Budesonide

最新研究结果证实，耐赋康®在“四重打击”中第一、二、三重打击均有积极作用，最终实现减少50%的肾功能恶化1。既往研究已证实，耐赋康®作用于第一重打击，显著降低血液中的Gd-IgA1水平。NefIgArd试验的完整分析发现，其不仅显著降低循环中Gd-IgA1水平，还显著降低第二重打击的生物标志物IgG抗IgA抗体、第三重打击的生物标志物IgA-IC水平。最新研究发现，在最初治疗的2个月内Gd-IgA1或多聚IgA，尤其多聚IgA的变化与降蛋白尿效果显著相关，提示它们可能成为指导耐赋康®治疗的生物标志物。两项最新研究进一步揭示了耐赋康®通过靶向肠道调节，显著降低致病性半乳糖缺陷型IgA1（Gd-IgA1）、IgG抗IgA抗体及免疫复合物水平，并发现Gd-IgA1或多聚IgA最初两个月内的变化与降蛋白尿效果具有相关性，为其对因治疗提供了更多证据。在第62届欧洲肾脏协会（ERA 2025）大会上，耐赋康®（布地奈德肠溶胶囊，NEFECON®）展示了9项最新研究成果，涵盖从疗效预测的生物标志物到不同诊断时间、基线肾功能水平患者的疗效评估，再到长期治疗的可持续性分析，以及对作用机制和安全性的探讨。此次会上两项最新研究证实，耐赋康®通过靶向肠道调节，显著降低致病性半乳糖缺陷型IgA1（Gd-IgA1）、IgG抗IgA抗体及免疫复合物水平，并发现Gd-IgA1或多聚IgA最初两个月内的变化与降蛋白尿效果具有相关性，为“对因治疗”策略提供了坚实支持，全面夯实了耐赋康®IgA肾病首选对因治疗地位，为其在“对因治疗、尽早治疗、全部治疗”新管理策略中提供了强有力的循证支持与理论基础。作为靶向肠道黏膜免疫调节剂，耐赋康®是首个且唯一在中国、美国和欧洲获得完全批准的IgA肾病对因治疗药物，并同时获得《2024版KDIGO IgA肾病和IgA血管炎临床管理实践指南（公开审查版）》以及《中国成人IgA肾病及IgA血管炎临床实践指南（预审版本）》国内外指南推荐，证实了其作为IgA肾病一线基石治疗的领导地位。吕继成教授北京大学第一医院既往研究已证实，布地奈德肠溶胶囊作用于第一重打击，显著降低血液中的Gd-IgA1水平。此次NefIgArd试验的完整分析发现，其不仅显著降低循环中Gd-IgA1水平，还显著降低第二重打击的生物标志物IgG抗IgA抗体、第三重打击的生物标志物IgA-IC水平。这些结果提示，布地奈德肠溶胶囊在“四重打击”中第一、二、三重打击均有积极作用，最终实现减少50%的肾功能恶化1。此外，最新研究发现，在最初治疗的2个月内Gd-IgA1或多聚IgA，尤其多聚IgA的变化与降蛋白尿效果显著相关，提示它们可能成为指导布地奈德肠溶胶囊治疗的生物标志物。因此，布地奈德肠溶胶囊通过特异性调节肠道黏膜免疫，减少Gd-IgA1的产生，从而阻止下游的病理途径，最终有效控制蛋白尿并保护肾功能。其局部靶向性不仅提高了治疗的安全性，还开启了对因治疗的全新策略，为国内外IgA肾病治疗理念的变革和指南的更新奠定了证据基础。罗永庆云顶新耀首席执行官在ERA 2025大会上公布的多项最新研究成果，进一步证实了耐赋康®从源头干预IgA肾病发病机制、延缓疾病进展及保护肾功能的临床价值，巩固了其作为首选对因治疗药物的领导地位。IgA肾病在中国是最常见的原发性肾小球疾病，患者人数庞大，起病隐匿且进展迅速。据估计，我国IgA肾病患者超过500万，每年新增确诊病例超过10万例，发病人群多为青中年，疾病负担沉重，若延误治疗，易发展为终末期肾病，造成患者、家庭及社会的多重压力。作为全球首个也是目前唯一在中国、美国和欧洲获得完全批准，且不受蛋白尿水平限制的IgA肾病对因治疗药物，耐赋康®已被多项中外指南推荐，为‘对因治疗、尽早治疗、全部治疗’的IgA肾病新疾病管理策略提供了坚实的科学依据和临床支持。这一策略正重塑IgA肾病的治疗路径，有望为更广泛患者群体带来更多治疗选择。作为全球首个IgA肾病对因治疗药物，耐赋康®具体作用路径在最新研究中得到进一步验证。在一项布地奈德肠溶胶囊对IgA肾病第一、二、三重打击影响研究的NefIgArd试验的完整分析2中，从216例NefIgArd试验参与者（每组108例）中收集基线以及3、6、9、12和18个月时的血清样本，测量Gd-IgA1、IgG抗IgA抗体和IgA免疫复合物（IgA-IC）水平。结果显示，与安慰剂相比，布地奈德肠溶胶囊在3、6、9和12个月时显著降低循环中Gd-IgA1水平（图1）；在3、6和9个月治疗时显著降低IgG抗IgA抗体水平，12个月时水平接近基线（图2）；在3个月时显著降低IgA-IC水平，并在6和9个月时维持了数值上的降低（图3）。这项18个月的生物标志物数据显示，布地奈德肠溶胶囊通过作用于第一重打击，对后续第二、三重打击也有积极的调节作用，表明其可从源头阻断IgA肾病的进展。图1. 第一重打击的作用：循环中Gd-IgA1水平的变化图2. 第二重打击的作用：IgG抗IgA抗体水平的变化图3. 第三重打击的作用：IgA-IC水平的变化在另一项Gd-IgA1、多聚IgA在布地奈德肠溶胶囊治疗IgA肾病中的预测价值的中国研究3中，收集了27例接受布地奈德肠溶胶囊治疗的IgA肾病成年患者的血清样本，测量血Gd-IgA1和多聚IgA水平，并分析这两项生物标志物基线水平及其变化与蛋白尿减少之间的关系。结果显示，基线平均蛋白尿为1.3 g/d。在随访期间，蛋白尿随时间逐渐降低，在3、6、9和12个月时，分别降低0.12 g/d、0.42 g/d、0.58 g/d和0.86 g/d。血浆中Gd-IgA1、多聚IgA在治疗后的2个月内分别显著降低1067.3 ng/ml、1.18 mg/l，它们的降低均与蛋白尿减少显著相关（P<0.0001）（图4），尤其多聚IgA在最初两个月内的变化与6个月时蛋白尿减少具有显著相关性（P=0.01）。同时，对Gd-IgA1也观察到了类似的趋势。该病例系列研究结果表明，Gd-IgA1或多聚IgA可能成为指导布地奈德肠溶胶囊治疗的生物标志物。图4. 多聚IgA及Gd-IgA1变化与蛋白尿变化的关系关于耐赋康®（NEFECON®）耐赋康®(NEFECON®)是布地奈德肠溶胶囊，作为全球首个对因治疗IgA肾病的药物，是靶向肠道黏膜B细胞的免疫调节剂，能减少50%肾功能下降1，在中国人群中能延缓肾功能衰退达66%4，预计将疾病进展至透析或肾移植的时间延缓12.8年5。同时布地奈德首过代谢程度达90%6，具有良好的安全性。耐赋康®专为IgA肾病患者研制，每颗胶囊含布地奈德4mg，通过特殊的迟释及缓释双重制剂工艺，将布地奈德靶向释放于回肠末端的黏膜B细胞（包括派尔集合淋巴结），胶囊溶解后，三层包衣微丸持续稳定释放布地奈德，高浓度覆盖整个靶区域，从而减少诱发IgA肾病的半乳糖缺陷的IgA1抗体（Gd-IgA1）产生，进而干预发病机制上游阶段，达到治疗IgA肾病的作用。2019年6月，云顶新耀与Calliditas Therapeutics 签订独家授权许可协议，获得在大中华地区和新加坡开发以及商业化耐赋康®的权利。该协议于2022年3月扩展，将韩国纳入云顶新耀的授权许可范围。关于云顶新耀云顶新耀是一家专注于创新药和疫苗研发、临床开发、制造和商业化的生物制药公司，致力于满足亚洲市场尚未满足的医疗需求。云顶新耀的管理团队在中国及全球领先制药企业从事过高质量研发、临床开发、药政事务、化学制造与控制（CMC）、业务发展和商业化运营，拥有深厚的专长和丰富的经验。云顶新耀已打造多款疾病首创或者同类最佳的药物组合，公司的治疗领域包括肾科疾病、感染性和传染性疾病、自身免疫性疾病。有关更多信息，请访问公司网站：www.everestmedicines.com。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述，乃基于本公司或管理层在做出表述时对公司业务运营情况及财务状况的现有看法、相信、和现有预期，可能会使用“将”、“预期”、“预测”、“期望”、“打算”、“计划”、“相信”、“预估”、“确信”及其他类似词语进行表述。这些前瞻性表述并非对未来业绩的保证，会受到风险、不确定性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展等各种因素及假设的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司及各附属公司、各位董事、管理人员、顾问及代理未曾且概不承担更新该稿件所载前瞻性表述以反映在本新闻稿发布日后最新信息、未来项目或情形的任何义务，除非法律要求。参考文献1.Lafayette R,et al. Lancet. 2023 Sep 9;402(10405):859-870.2.Ishika Khan, et al. Abstract#2642-Effects of Nefecon on Hits 1, 2, and 3 of the pathogenic cascade of IgA nephropathy: a full NefIgArd analysis. Presented at ERA 2025.3.Chen Qinlan, et al. Abstract#732-Predictive Value of Gd-IgA1, Poly-IgA in the Treatment of IgA Nephropathy with Targeted Release Formulation-Budesonide. Presented at ERA 2025.4.2023ASN. Oral presentation.5.Jonathan Barratt,et al. 2023 ASN. Poster no. SA-PO886.6.Edsbäcker S,et al. Aliment Pharmacol Ther. 1999 Feb;13(2):219-24.

Daix (France), New York City (New York, United States), June 10, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the appointment of Renée Aguiar-Lucander to its Board of Directors. The appointment was approved by shareholders at the recent Company’s Annual General Meeting. Mark Pruzanski, Chairman of Inventiva: “ We are thrilled to welcome Renée to the Board at this pivotal moment in Inventiva’s journey. Her exceptional track record in our industry speaks for itself and will be key as we enter the final stages of clinical development for lanifibranor and prepare for its potential approval and launch.” Renée Aguiar-Lucander : “ I’m honored to have the opportunity to join Inventiva’s Board. With the NATiV3 Phase 3 trial fully enrolled, I look forward to working with the team to potentially bring lanifibranor to patients with MASH. ” Mrs. Aguiar-Lucander has served as the Chief Executive Officer of Hansa Biopharma since April 2025. She was previously Chief Executive Officer of Calliditas Therapeutics, where she led the transformation of the company from a small biotech company into a NASDAQ-listed, commercial-stage leader in rare diseases, culminating in its $1.1 billion acquisition by Asahi Kasei in 2024. Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy (TARPEYO®) and successfully launched the product in the U.S. Prior to her role at Calliditas, Ms. Aguiar-Lucander held various senior roles in the field of life sciences investment and corporate finance, including Partner and COO at Omega Fund Management and Managing Director at a global investment bank. She holds an MBA from INSEAD and a BA in Finance from the Stockholm School of Economics. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com Contacts Inventiva Pascaline Clerc EVP, Strategy and Corporate Affairs media@inventivapharma.com +1 202 499 8937 Brunswick Group Tristan Roquet Montegon / Aude Lepreux / Julia Cailleteau Media relations inventiva@brunswickgroup.com +33 1 53 96 83 83 ICR Healthcare Patricia L. Bank Investor relations patti.bank@icrhealthcare.com +1 415 513 1284 Important Notice This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, Inventiva’s clinical trials, including Inventiva’s ongoing NATiV3 Phase 3 clinical trial of lanifibranor in MASH, including related timing and regulatory matters, Inventiva’s pipeline development plans, the clinical development of and regulatory plans and pathway for lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing, to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners’ clinical trials may not support Inventiva's and its partners’ product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners’ control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s and its partners' business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in law and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil and natural catastrophes, uncertain financial markets and disruptions in banking systems, and the vote of Inventiva’s shareholders. The review of potential financial and strategic options may not result in any particular action or transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024, filed with the Autorité des Marchés Financiers on April 15, 2025, and the Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors” and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Appointment Renee Aguiar Lucanter to the Board - EN - 06 10 2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.