Rifabutin

RHB-2041 is a next-generation optimized formulation of RedHill's oral RHB-1042, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking Mycobacterium avium subspecies paratuberculosis (MAP)-targeted therapeutic approach for Crohn's disease (CD) In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048)3 New RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-1044. Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects Based on the FDA guidance on path to approval, RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm changing approach to treatment of Crohn's disease. With discussions ongoing and grant application submitted, funding for this program is planned to be non-dilutive Expected transferal of RHB-104's FDA pediatric orphan drug designation to RHB-204, potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher. RHB-204 is patent protected through 2041, granted FDA Fast Track and Orphan Drug Designation, QIDP Designation under the GAIN Act (extending US market exclusivity to a potential total of 12 years) and EU Orphan Designation (eligibility for 10 years EU market exclusivity) for NTM disease caused by MAC5 The multibillion-dollar CD market is expected to grow from $13.6 billion in 2024 to over $19 billion in 2033 in key markets,6 presenting a significant opportunity for new FDA-approved therapies RALEIGH, N.C. and TEL AVIV, Israel, April 30, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis (MAP) killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking MAP-targeted therapeutic approach to the treatment of Crohn's disease (CD). The comparability results were achieved in both spot and phage assays of several different MAP strains. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects. "As published in the peer-reviewed journal, Antibiotics3, RedHill's RHB-104 had previously delivered positive Phase 3 results showing a statistically significant 64% improvement in efficacy in treating CD using this potentially transformative MAP-targeted approach, achieving the primary endpoint of induction of clinical remission at week 26 (p = 0.0048). The demonstration of RHB-204's comparability to RHB-104 is an important step forward in the ongoing development of RHB-204 for MAP-related CD, following the pathway to approval guided by the FDA at our positive meeting," said Reza Fathi, PhD, Senior VP, R&D at RedHill. "Up to 40% of CD patients fail to respond to anti-TNF treatment, and over time a similar number of responders lose response and have disease flare-ups7. Many existing treatment options are both expensive and intravenously administered, further increasing the cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings. A safe and effective orally administered therapy would provide a welcome alternative approach." A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. There is a significant body of peer reviewed published research supporting the scientific rationale that MAP may be a root cause of CD8, however, a major hurdle in previous clinical studies for new therapies directed at MAP has been the ability to rapidly and accurately detect MAP – one of the slowest growing and hard to detect bacteria on the planet. This study, along with RedHill's collaborations with two leading European academic centers for the provision of cutting-edge MAP detection diagnostics, which support the study's novel design and the potential future commercial application of RHB-204, represents a groundbreaking approach that could potentially make RHB-204, if approved, an exciting new therapy treating both the suspected cause of the disease and its symptoms. RedHill is actively pursuing partnerships and collaborations for this program, including via an innovation development grant application, which has already been submitted. In addition, RedHill is engaging in ongoing discussions with non-dilutive external funding sources. The development of RHB-204 is supported by a strong foundation of published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, achieving clinical CD remission at week 26 (the primary endpoint) in 36.7% of the RHB-104-treated group compared to 22.4% in the placebo (standard of care only) group3. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy3. The CD market is expected to expand significantly through 2033, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%5. About RHB-204 RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease. Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to the U.S. Food and Drug Administration (FDA) approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Originally developed for the treatment of pulmonary non-tuberculous mycobacteria (NTM) disease caused by Mycobacterium avium complex (MAC), RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. Where applicable, the Company intends to explore the potential for additional regulatory process designations, such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers. About Crohn's Disease Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications. There is no known cure for Crohn's disease. It is estimated that 1 million Americans9 and approximately 6-8 million people globally have Crohn's disease10. Commonly used FDA-approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib). About RedHill Biopharma RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults11, with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (NASDAQ: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for medical countermeasures including radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases. Visit / X.com/RedHillBio for more information about the Company Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the potential transferal of pediatric orphan drug designation to RHB-204, the potential for breakthrough therapy designations, fast track designations, additional regulatory exclusivity and priority review vouchers, the potential for partnerships and funding sources for the development of RHB-204, and the potential success of any transactions, commercial programs or development activities. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia; (v) the Company's ability to successfully commercialize and promote Talicia; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) the Company's ability to collect on its judgement against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 27, 2026. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate and Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: R&D 1 RHB-204 is an investigational new drug, not available for commercial distribution in the United States. 2 RHB-104 is an investigational new drug, not available for commercial distribution in the United States. 3 Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694. PMID: 39199994; PMCID: PMC11350828. 4 Data on file 5 Non-tuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) 6 DataMonitor - Disease Analysis: Crohn's Disease, September 2024 7 Singh S, George J, Boland BS, Vande Casteele N, Sandborn WJ. Primary Non-Response to Tumor Necrosis Factor Antagonists is Associated with Inferior Response to Second-line Biologics in Patients with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis. 2018 May 25;12(6):635-643. doi: 10.1093/ecco-jcc/jjy004. PMID: 29370397; PMCID: PMC7189966. 8 Bull T.J., McMinn E.J., Sidi-Boumedine K., Skull A., Durkin D., Neild P., Rhodes G., Pickup R., Hermon-Taylor J. Detection and verification of Mycobacterium avium subsp. paratuberculosis in fresh ileocolonic mucosal biopsy specimens from individuals with and without Crohn's disease. J. Clin. Microbiol. 2003;41:2915–2923. doi: 10.1128/JCM.41.7.2915-2923.2003 9 Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165:1197–1205. doi:10.1053/j.gastro.2023.07.003 10 Heydari K, Rahnavard M, Ghahramani S, Hoseini A, Alizadeh-Navaei R, Rafati S, Raei M, Vahidipour M, Salehi F, Motafeghi F, Neshat S, Moosazadeh M, Yousefi M, Pourali A, Rasouli K, Shokrirad S, Lotfi P, Beladi SA, Hadizadeh Neisanghalb M, Sheydaee F, Moghadam S. Global prevalence and incidence of inflammatory bowel disease: a systematic review and meta-analysis of population-based studies. Gastroenterol Hepatol Bed Bench. 2025;18(2):132-146. doi: 10.22037/ghfbb.v18i2.3105. PMID: 40936779; PMCID: PMC12421925. 11 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. 21% more press release views with Request a Demo

RHB-204 RHB-2041 1is a next-generation optimized formulation of RedHill's oral RHB-104 是RedHill口服RHB-104的下一代优化配方2 2, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking Mycobacterium avium subspecies paratuberculosis (MAP)-targeted therapeutic approach for Crohn's disease (CD) ，旨在提高耐受性、安全性并增强患者依从性，采用了一种突破性的针对鸟分枝杆菌副结核亚种 (MAP) 的治疗方法用于克罗恩病 (CD)。In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048) 在RHB-104的阳性III期研究中，该药物达到了主要和关键次要终点，具有统计学意义，显示在治疗克罗恩病（CD）时，与仅使用标准护理（SoC）的安慰剂组相比，RHB-104加标准护理比单独使用标准护理有效性提高了64%（p = 0.0048）。3 3New RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-104 新型RHB-204的体外数据（包括斑点测定和噬菌体测定）显示，其对MAP的杀灭效果与RHB-104相当。4 4. Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects 重要的是，与RHB-104相比，MAP杀伤效力是通过较低剂量的两种活性成分实现的，这表明有可能降低毒性和副作用。Based on the FDA guidance on path to approval, RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm changing approach to treatment of Crohn's disease. With discussions ongoing and grant application submitted, funding for this program is planned to be non-dilutive . 基于FDA关于审批路径的指导，RedHill新颖的二期RHB-204研究被设计为首个在特定定义的MAP阳性CD患者群体中进行的充分对照临床研究——这是一种可能改变克罗恩病治疗模式的方法。随着讨论的持续进行和资助申请的提交，该计划的资金预计将不具稀释性。Expected transferal of RHB-104's FDA pediatric orphan drug designation to RHB-204, potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher. RHB-204 is patent protected through 2041, granted FDA Fast Track and Orphan Drug Designation, QIDP Designation under the GAIN Act (extending US market exclusivity to a potential total of 12 years) and EU Orphan Designation (eligibility for 10 years EU market exclusivity) for NTM disease caused by MAC. 预计RHB-104的FDA儿科孤儿药资格将转移至RHB-204，有可能获得突破性疗法资格、快速通道资格、额外的监管独占权以及优先审查券。RHB-204受专利保护至2041年，已获得FDA快速通道和孤儿药资格认定，GAIN法案下的QIDP资格（将美国市场独占期延长至潜在总计12年），以及欧盟孤儿药资格（符合10年欧盟市场独占条件），适用于由MAC引起的NTM疾病。5 5The multibillion-dollar CD market is expected to grow from $13.6 billion in 2024 to over $19 billion in 2033 in key markets, 预计在关键市场中，价值数十亿美元的CD市场将从2024年的136亿美元增长到2033年的超过190亿美元，6 6presenting a significant opportunity for new FDA-approved therapies 呈现出新FDA批准疗法的重大机遇RALEIGH, N.C. and TEL AVIV, Israel 北卡罗来纳州罗利和以色列特拉维夫, ，April 30, 2026 2026年4月30日/PRNewswire/ -- /PRNewswire/ --RedHill Biopharma Ltd. 红山生物制药有限公司 (NASDAQ: （纳斯达克：RDHL RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced new `)('RedHill'或'公司')，一家专业生物制药公司，今天宣布了新的`in vitro 体外testing results demonstrating RHB-204's comparability to RHB-104 in 测试结果表明 RHB-204 与 RHB-104 具有可比性 Mycobacterium avium subspecies paratuberculosis 副结核分枝杆菌亚种(MAP) killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking MAP-targeted therapeutic approach to the treatment of Crohn's disease (CD). (MAP) 杀灭效果。口服RHB-204是RedHill公司RHB-104的下一代优化配方，旨在提高耐受性、安全性，并增强患者依从性，采用了一种突破性的MAP靶向治疗方案用于克罗恩病（CD）的治疗。The comparability results were achieved in both spot and phage assays of several different MAP strains. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects. 在几种不同MAP菌株的斑点和噬菌体检测中均取得了可比的结果。重要的是，与RHB-104相比，两种活性成分在较低剂量下即达到了MAP杀灭效果，这表明其具有降低毒性和副作用的潜力。'As published in the peer-reviewed journal, '如同行评审期刊中所发表的，Antibiotics 抗生素3 3, RedHill's RHB-104 had previously delivered positive Phase 3 results showing a statistically significant 64% improvement in efficacy in treating CD using this potentially transformative MAP-targeted approach, achieving the primary endpoint of induction of clinical remission at week 26 (p = 0.0048). RedHill公司的RHB-104此前在3期试验中取得了积极结果，显示通过这种潜在的变革性MAP靶向方法治疗CD时，疗效显著提高了64%，达到了第26周临床缓解诱导的主要终点（p = 0.0048）。The demonstration of RHB-204's comparability to RHB-104 is an important step forward in the ongoing development of RHB-204 for MAP-related CD, following the pathway to approval guided by the FDA at our positive meeting,' . RHB-204与RHB-104的对比研究表明，这是在FDA于我们积极会议中指导的批准路径下，RHB-204针对MAP相关CD持续开发的重要一步。said Reza Fathi, PhD, Senior VP, R&D at RedHill 雷扎·法蒂博士，RedHill公司研发高级副总裁表示. 'Up to 40% of CD patients fail to respond to anti-TNF treatment, and over time a similar number of responders lose response and have disease flare-ups “多达40%的克罗恩病患者对抗TNF治疗无反应，随着时间推移，相似数量的有反应者会失去反应并出现疾病复发。”7 7. Many existing treatment options are both expensive and intravenously administered, further increasing the cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings. A safe and effective orally administered therapy would provide a welcome alternative approach.'. 许多现有的治疗方案既昂贵又需静脉注射，进一步增加了成本负担。此外，这些现有疗法中有几种存在已知的安全问题，包括黑框警告。一种安全有效的口服疗法将提供一种受欢迎的替代方法。A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. There is a significant body of peer reviewed published research supporting the scientific rationale that MAP may be a root cause of CD 预计RHB-204在克罗恩病（CD）中的计划二期研究将是首个针对明确界定的MAP阳性CD患者群体的临床研究。有大量经过同行评议的已发表研究支持这一科学依据，即MAP可能是CD的根本原因。8 8, however, a major hurdle in previous clinical studies for new therapies directed at MAP has been the ability to rapidly and accurately detect MAP – one of the slowest growing and hard to detect bacteria on the planet. This study, along with RedHill's collaborations with two leading European academic centers for the provision of cutting-edge MAP detection diagnostics, which support the study's novel design and the potential future commercial application of RHB-204, represents a groundbreaking approach that could potentially make RHB-204, if approved, an exciting new therapy treating both the suspected cause of the disease and its symptoms.. 然而，以往针对MAP的新疗法临床研究中的一个主要障碍是能够快速且准确地检测MAP——这是地球上生长最缓慢、最难检测的细菌之一。本研究以及RedHill与两家欧洲领先的学术中心合作提供的尖端MAP检测诊断技术，支持了这项研究的创新设计，并为RHB-204潜在的未来商业应用奠定了基础，这一突破性的方法可能使RHB-204在获批后成为一种令人兴奋的新疗法，既能治疗疾病的疑似病因，又能缓解其症状。RedHill is actively pursuing partnerships and collaborations for this program, including via an innovation development grant application, which has already been submitted. In addition, RedHill is engaging in ongoing discussions with non-dilutive external funding sources. RedHill 正在积极为该项目寻求合作伙伴关系和合作，包括通过已提交的创新开发资助申请。此外，RedHill 正在与非稀释性外部资金来源进行持续讨论。The development of RHB-204 is supported by a strong foundation of published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, achieving clinical CD remission at week 26 (the primary endpoint) in 36.7% of the RHB-104-treated group compared to 22.4% in the placebo (standard of care only) group. RHB-204 的开发基于 RHB-104 在活动性克罗恩病（CD）中的 3 期随机、双盲、安慰剂对照 331 例研究中发表的强有力的临床疗效和安全性数据支持，该研究成功达到了主要和次要终点，显示 RHB-104 加标准治疗（SoC）比单独使用标准治疗有效性高出 64%，在第 26 周达到临床 CD 缓解（主要终点）的比例为 RHB-104 治疗组的 36.7%，而安慰剂（仅标准治疗）组为 22.4%。3 3. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy 第三阶段研究还证明了RHB-104与抗TNF、免疫调节剂和类固醇联合使用的安全性和有效性，表明RHB-204可能是一种变革性的、安全有效的、单独使用或联合使用的口服疗法。3 3. 。The CD market is expected to expand significantly through 2033, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87% 预计CD市场到2033年将显著扩张，美国、日本和欧洲五大主要市场的销售额将从136亿美元增长到191亿美元，复合年增长率（CAGR）为3.87%。5 5. 。About RHB-204 关于RHB-204RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat RHB-204 是一种专利的固定剂量口服胶囊，包含特定剂量的克拉霉素、利福布汀和氯法齐明，旨在安全有效地治疗。Mycobacterium avium subspecies paratuberculosis 副结核分枝杆菌亚种-positive (MAP-positive)-related Crohn's disease. -阳性（MAP阳性）相关的克罗恩病。Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to the U.S. Food and Drug Administration (FDA) approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. 专利保护至少到2041年，并有望获得儿科孤儿药资格（需经美国食品药品监督管理局（FDA）批准从RHB-104转移），RHB-204是RHB-104的下一代制剂，针对克罗恩病（CD）治疗进行了优化。它包含相同的三种具有强效细胞内、抗分枝杆菌和抗炎特性的抗菌药物，且通过优化的剂量方案，RHB-204可将药片负担减少40%，从而提升耐受性、安全性和患者依从性。RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD.. RHB-204 得益于 RHB-104 在克罗恩病 (CD) 的 III 期临床试验中取得的积极安全性和有效性结果的强大临床数据支持，其潜力还通过黏膜愈合成像得以进一步验证，该成像被认为是评估克罗恩病疗效的金标准。Originally developed for the treatment of pulmonary non-tuberculous mycobacteria (NTM) disease caused by 最初开发用于治疗由非结核分枝杆菌（NTM）引起的肺部疾病Mycobacterium avium complex 鸟分枝杆菌复合群(MAC), RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. (MAC)、RHB-204 已获得 FDA 快速通道和孤儿药资格认定，此外还根据《推动抗生素激励法案》（GAIN 法案）获得了 QIDP 资格认定，将美国批准后的市场独占期延长至潜在总计 12 年。RHB-204 还获得了欧盟孤儿药资格认定，可享有欧盟批准后 10 年的市场独占权。Where applicable, the Company intends to explore the potential for additional regulatory process designations, such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers.. 在适用的情况下，公司打算探索额外的监管程序指定的潜力，例如突破性疗法指定和快速通道指定，这些可能提供额外的独占权或优先审查券的潜力。About Crohn's Disease 关于克罗恩病Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications. 克罗恩病（CD）是一种炎症性肠病（IBD），会引起消化道组织的炎症，导致腹痛、严重腹泻、疲劳、体重减轻和营养不良。克罗恩病可能令人极度虚弱，并对患者和医疗系统造成严重的负担：破坏生活质量，甚至引发危及生命的并发症。There is no known cure for Crohn's disease. It is estimated that 1 million Americans. 克罗恩病尚无已知的治愈方法。据估计，有一百万美国人患病。9 9and approximately 6-8 million people globally have Crohn's disease 全球大约有600万到800万人患有克罗恩病。10 10. 。Commonly used FDA-approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib). 常用于治疗克罗恩病的FDA批准疗法包括：艾伯维的Humira®（阿达木单抗）、杨森的Remicade®（英夫利昔单抗）和Stelara®（乌司奴单抗）、百时美施贵宝的Zeposia®（奥扎莫德）以及辉瑞的Xeljanz®（托法替尼）。About RedHill Biopharma 关于RedHill生物制药公司RedHill Biopharma Ltd. (NASDAQ: RedHill 生物制药有限公司 (NASDAQ:RDHL RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug ）是一家专注于美国市场胃肠疾病、传染病和肿瘤学药物开发与商业化的专业生物制药公司。RedHill 推广经 FDA 批准的胃肠药物。Talicia, 塔莉西亚，for the treatment of 用于治疗Helicobacter pylori (H. pylori) 幽门螺杆菌 (H. pylori)infection in adults 成人感染11 11, with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (NASDAQ: ，与Cumberland Pharmaceuticals（纳斯达克：）签订了美国共同商业化协议CPIX CPIX). RedHill's key clinical late-stage development programs include: (i) ). RedHill的关键临床后期开发计划包括：(i)opaganib (ABC294640) 奥帕尼布 (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for medical countermeasures including radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) . ，一种首创的口服鞘氨醇激酶-2（SPHK2）选择性抑制剂，具有抗炎、抗病毒、代谢和抗癌活性，针对多种适应症，并与美国政府和学术机构合作开发医疗对策，包括辐射和化学暴露适应症，如胃肠道急性辐射综合症（GI-ARS）、一个针对住院COVID-19患者的II/III期项目，以及一项与达洛鲁胺联合用于前列腺癌的正在进行的II期研究；（ii）。RHB-102 (Bekinda) RHB-102（Bekinda）, with a planned Phase 2 proof-of-concept study for ，计划进行2期概念验证研究以GLP-1 GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) . /GIP受体激动剂相关的胃肠道不耐受，美国急性胃肠炎和胃炎的3期研究取得积极结果，美国IBS-D的2期研究取得积极结果，并计划在英国提交用于化疗和放疗引起的恶心和呕吐。RHB-102与Hyloris Pharmaceuticals（EBR：HYL）合作，在北美以外地区进行全球开发和商业化；(iii)。RHB-204 RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) 下一代优化配方的RHB-104，计划进行针对克罗恩病的二期研究（基于RHB-104在三期克罗恩病研究中的积极结果）；以及 (iv)RHB-107 RHB-107( (upamostat 向上移动状态), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases. ），一种口服广谱、宿主导向的丝氨酸蛋白酶抑制剂，具有应对大流行病的潜力，包括新冠肺炎，同时也针对多种癌症和炎症性胃肠道疾病。Visit 访问www.redhillbio.com www.redhillbio.com/ /X.com/RedHillBio X.com/RedHillBiofor more information about the Company 有关公司的更多信息，请参阅Forward Looking Statements 前瞻性声明This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words, and include, among others, statements regarding the potential transferal of pediatric orphan drug designation to RHB-204, the potential for breakthrough therapy designations, fast track designations, additional regulatory exclusivity and priority review vouchers, the potential for partnerships and funding sources for the development of RHB-204, and the potential success of any transactions, commercial programs or development activities. 本新闻稿包含1995年《私人证券诉讼改革法案》意义上的“前瞻性声明”，并可能讨论投资机会、股票分析、财务业绩、投资者关系和市场趋势。这些声明可能以“打算”、“可能”、“将”、“计划”、“预期”、“预计”、“预测”、“估计”、“目标”、“相信”、“希望”、“潜力”或类似词语为前导，其中包括但不限于关于将儿科孤儿药资格转让给RHB-204的潜在可能性、突破性疗法资格的潜力、快速通道资格、额外的监管独占权和优先审查券、RHB-204开发的潜在合作伙伴和资金来源，以及任何交易、商业计划或开发活动的潜在成功等声明。Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. 前瞻性声明基于某些假设，并受到各种已知和未知的风险及不确定性的影响，其中许多风险和不确定性是公司无法控制的，也无法预测或量化，因此，实际结果可能与这些前瞻性声明所表达或暗示的内容存在重大差异。Such risks and uncertainties include, without limitation: the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce . 此类风险和不确定性包括但不限于：RHB-204针对克罗恩病的开发可能无法完成，或即使完成也可能未获批准或无法实现商业成功；opaganib对我们的产品所针对的适应症无效的风险；RHB-102（Bekinda）无法有效减少。GLP-1 GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. /GIP相关的恶心、呕吐和腹泻；公司能否重新获得并维持与纳斯达克上市要求（包括最低出价要求）的合规性的风险；新增收入产品或外部许可交易无法实现的风险；公司不会根据现有协议收到未来的里程碑付款，或者该款项少于预期的风险；当前关于美国的不确定性风险。government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into . 政府研发资金，而且美国政府没有义务继续支持我们产品的开发，并且可以随时停止此类支持；产品被纳入RNCP产品开发管线或其他政府和非政府开发项目并不保证持续开发，也不能保证任何此类开发能够完成或取得成功；FDA可能不同意公司为其项目提出的开发计划；公司的开发项目和研究可能不会成功，即使成功，这些研究和结果也可能不足以满足监管申请（包括紧急使用或上市申请），并且可能需要进行额外的研究；公司可能无法成功将其产品商业化；以及与以下事项相关的风险和不确定性：(i) 公司研究、制造、临床前研究、临床试验和其他治疗候选产品开发工作的启动、时间安排、进展和结果，及其商业产品和未来可能收购或开发的产品的商业发布时间；(ii) 公司将其治疗候选产品推进到下一阶段的能力。Company contact: 公司联系人：Adi Frish 阿迪·弗里什Chief Corporate and Business Development Officer 首席企业与业务发展官RedHill Biopharma 红山生物制药公司+972-54-6543-112 +972-54-6543-112[email protected] 电子邮件地址Category: R&D 类别：研发1 1RHB-204 is an investigational new drug, not available for commercial distribution in the United States. RHB-204 是一种研究性新药，在美国尚未获得商业销售许可。2 2RHB-104 is an investigational new drug, not available for commercial distribution in the United States. RHB-104 是一种研究性新药，在美国尚未上市销售。3 3Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694. PMID: 39199994; PMCID: PMC11350828. Graham DY 等。抗分枝杆菌治疗（RHB-104）在活动性克罗恩病中的随机、双盲、安慰剂对照研究。《抗生素》（巴塞尔）。2024年7月25日；13(8):694。doi: 10.3390/antibiotics13080694。PMID: 39199994；PMCID: PMC11350828。4 4Data on file 数据存档5 5Non-tuberculous mycobacteria (NTM) lung disease caused by 由非结核分枝杆菌（NTM）引起的肺病Mycobacterium avium complex 鸟分枝杆菌复合群(MAC) （MAC）6 6DataMonitor - Disease Analysis: Crohn's Disease, September 2024 数据监测 - 疾病分析：克罗恩病，2024年9月7 7Singh S, George J, Boland BS, Vande Casteele N, Sandborn WJ. Primary Non-Response to Tumor Necrosis Factor Antagonists is Associated with Inferior Response to Second-line Biologics in Patients with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis. 2018 May 25;12(6):635-643. Singh S, George J, Boland BS, Vande Casteele N, Sandborn WJ。肿瘤坏死因子拮抗剂的原发性无反应与炎症性肠病患者对二线生物制剂的反应较差相关：系统评价与荟萃分析。《克罗恩病与结肠炎杂志》。2018年5月25日；12（6）：635-643。doi: 10.1093/ecco-jcc/jjy004. PMID: 29370397; PMCID: PMC7189966.. doi: 10.1093/ecco-jcc/jjy004. PMID: 29370397; PMCID: PMC7189966。8 8Bull T.J., McMinn E.J., Sidi-Boumedine K., Skull A., Durkin D., Neild P., Rhodes G., Pickup R., Hermon-Taylor J. Detection and verification of Mycobacterium avium subsp. paratuberculosis in fresh ileocolonic mucosal biopsy specimens from individuals with and without Crohn's disease. J. Clin. Microbiol. 布尔 T.J.，麦克明 E.J.，西迪-布梅迪内 K.，斯库尔 A.，杜尔金 D.，尼尔德 P.，罗兹 G.，皮克普 R.，赫蒙-泰勒 J. 检测和验证克罗恩病患者及非克罗恩病患者新鲜回结肠黏膜活检标本中的鸟分枝杆菌副结核亚种。《临床微生物学杂志》2003;41:2915–2923. doi: 10.1128/JCM.41.7.2915-2923.2003. 2003;41:2915–2923. doi: 10.1128/JCM.41.7.2915-2923.2003.9 9Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165:1197–1205. doi:10.1053/j.gastro.2023.07.003 刘易斯 JD，帕雷特 LE，容松·冯克 ML 等。美国炎症性肠病的发病率、患病率及种族和民族分布。《胃肠病学》。2023；165：1197–1205。doi:10.1053/j.gastro.2023.07.00310 10Heydari K, Rahnavard M, Ghahramani S, Hoseini A, Alizadeh-Navaei R, Rafati S, Raei M, Vahidipour M, Salehi F, Motafeghi F, Neshat S, Moosazadeh M, Yousefi M, Pourali A, Rasouli K, Shokrirad S, Lotfi P, Beladi SA, Hadizadeh Neisanghalb M, Sheydaee F, Moghadam S. Global prevalence and incidence of inflammatory bowel disease: a systematic review and meta-analysis of population-based studies. Heydari K, Rahnavard M, Ghahramani S, Hoseini A, Alizadeh-Navaei R, Rafati S, Raei M, Vahidipour M, Salehi F, Motafeghi F, Neshat S, Moosazadeh M, Yousefi M, Pourali A, Rasouli K, Shokrirad S, Lotfi P, Beladi SA, Hadizadeh Neisanghalb M, Sheydaee F, Moghadam S。全球炎症性肠病的患病率和发病率：基于人口研究的系统评价与荟萃分析。Gastroenterol Hepatol Bed Bench. 2025;18(2):132-146. doi: 10.22037/ghfbb.v18i2.3105. PMID: 40936779; PMCID: PMC12421925.. 胃肠病学与肝病学床边与实验室。2025；18（2）：132-146。doi：10.22037/ghfbb.v18i2.3105。PMID：40936779；PMCID：PMC12421925。11 11Talicia 塔利西亚® ®(omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of (奥美拉唑镁、阿莫西林和利福布汀) 适用于治疗H. pylori 幽门螺杆菌infection in adults. For full prescribing information see: 成人感染。欲获取完整的处方信息，请参见：www.Talicia.com www.Talicia.com. 。Logo: 标志：https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpgSOURCE RedHill Biopharma Ltd. 来源：RedHill 生物制药有限公司21 21% %more press release views with 更多新闻发布视图与 Request a Demo 请求演示