An Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism Who Completed the 12-Week Treatment Period in the Phase 2 Study, MBX-2H1002 Study (Avail-Ext)

The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002.

开始日期2024-10-31

申办/合作机构

MBX Biosciences, Inc.初创企业

NCT06465108 / Recruiting临床2期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (Avail Study)

The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism.

开始日期2024-08-08

申办/合作机构

MBX Biosciences, Inc.初创企业

NCT06496217 / Recruiting临床1期

A Phase 1, Open-Label, Parallel-Group, Single Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function

Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function

开始日期2024-05-24

申办/合作机构

MBX Biosciences, Inc.初创企业

100 项与 MBX-2109 相关的临床结果

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100 项与 MBX-2109 相关的转化医学

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100 项与 MBX-2109 相关的专利（医药）

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项与 MBX-2109 相关的文献（医药）

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

MBX 2109, A Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-In-Human, Randomized Trial

Article

作者: Cutler, Gordon B ; Zhang, Fa ; DiMarchi, Richard ; Schneider, Kristi ; Carney, Patricia

Abstract:

Context:

Hypoparathyroidism denotes parathyroid hormone (PTH) deficiency and impaired mineral metabolism. MBX 2109, a novel prodrug yielding a biologically active PTH peptide agonist (PTH[1-32], extended by a fatty acylated Lys33), is being developed as a long-acting, once-weekly PTH replacement therapy.

Objective:

Here, we report the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MBX 2109 in healthy volunteers.

Methods:

This phase 1, randomized, double-blind, placebo-controlled, multiple ascending-dose study (NCT05158335) enrolled healthy adults, who were randomly assigned 4:1 to receive MBX 2109 (200, 400, 600, and 900 μg; n = 8) or placebo (n = 2) by subcutaneous administration once weekly for 4 doses (days 1, 8, 15, and 22). The primary end point was safety and tolerability. Key secondary end points were PK and PD.

Results:

Overall, 40 participants (MBX 2109 n = 32, placebo n = 8) were randomly assigned (mean age, 43.3 years; 22.5% female). Treatment-emergent adverse events (TEAEs) occurred in 50% to 88% of MBX 2109 groups and in 25% of placebo participants. In the MBX 2109 groups, no severe or serious TEAEs were observed. Injection-site reaction was the most common treatment-related TEAE. The half-lives were 79 to 95 hours for MBX 2109 and 184 to 213 hours for the fatty-acylated biologically active PTH peptide, which showed dose- and time-dependent exposure increases.

Conclusion:

The sustained-action PTH prodrug MBX 2109 was well tolerated with no unexpected, off-target safety issues. The long half-life and flat exposure profile of MBX 2109's biologically active PTH agonist supports once-weekly administration. MBX 2109 doses were identified for future studies.

项与 MBX-2109 相关的新闻（医药）

2024-12-08

·药明康德

“癌症之王”患者6个月生存率达97%的KRAS靶向小分子；100%晚期前列腺癌患者应答的创新疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 泛RAS抑制剂RMC-6236在携带RAS突变或野生型RAS的晚期实体瘤患者中展现出令人鼓舞的抗肿瘤活性和安全性，携带任意RAS突变的胰腺导管腺癌（PDAC）患者的6个月生存率达97%。 2. 在肿瘤激活T细胞接合器（TRACTr）JANX007治疗晚期或转移性去势抵抗性前列腺癌（mCRPC）患者的1a期临床试验中，100%的患者达到PSA 50（PSA水平下降≥50%）标准。 3. 在一项早期临床试验中，DFP-17729联用TS-1作为晚期胰腺癌患者三线或三线以上治疗，与对照治疗相比能够显著延长患者的中位总生存期（OS）近3个月。药明康德内容团队整理 RMC-6236：公布两项1/1b期临床试验的新数据 Revolution Medicines公司公布了其在研泛RAS抑制剂RMC-6236的最新临床结果。RMC-6236是一款口服、可靶向突变和野生型RAS在GTP结合（具活性，ON）状态下的选择性抑制剂。此次公布的1/1b期多中心、开放标签、剂量递增和剂量扩展研究RMC-6236-001旨在评估RMC-6236作为单药治疗携带RAS突变或野生型RAS晚期实体瘤患者的效果。分析显示，RMC-6236单药作为转移性PDAC患者二线疗法时显示出显著疗效，支持3期临床试验RASolute 302的持续推进，具体数据如下： ▲接受RMC-6236单药治疗PDAC患者的总生存率结果（图片来源：参考资料[2]） KRAS G12X突变患者（n=22）：中位无进展生存期（PFS）为8.8个月（95% CI：8.5个月–不可估计[NE]），中位OS仍不可估计（95% CI：NE–NE）。任意RAS突变患者（n=37）：中位PFS为8.5个月（95% CI：5.9个月–NE），中位OS仍不可估算（95% CI：8.5个月–NE）。 6个月生存率：KRAS G12X突变患者为100%，任意RAS突变患者为97%。客观缓解率（ORR）：KRAS G12X突变患者为36%，任意RAS突变患者为27%。 ▲接受RMC-6236治疗NSCLC患者的总生存期结果（图片来源：参考资料[2]） RMC-6236在经治NSCLC患者中的表现同样亮眼。截至2024年9月30日，最新数据涵盖了124名携带RAS突变的经治NSCLC患者，这些患者接受了每日一次120至300毫克的RMC-6236治疗。在此剂量范围内，RMC-6236展现良好的耐受性。在40名二线或三线NSCLC患者（这些患者既往接受过免疫疗法和铂类化疗，但未接受多西他赛）中，中位PFS为9.8个月（95% CI：6–12.3个月），中位OS为17.7个月（95% CI：13.7个月–NE），ORR为38%。 JANX007：公布1a期临床试验数据 Janux Therapeutics公司公布了在研疗法JANX007的积极中期临床数据。JANX007目前正在针对晚期或转移性去势抵抗性前列腺癌患者进行的1a期临床试验中接受评估。JANX007是一款靶向前列腺特异性膜抗原（PSMA）的肿瘤激活T细胞接合器，分别靶向PSMA和T细胞表面表达的CD3受体。它的设计让JANX007在肿瘤微环境中经过蛋白酶切割而被激活，从而在降低了其潜在毒性的同时，最大化抗肿瘤免疫反应。截至2024年11月15日的数据，共有16名患者以每周一次的给药方案接受2-9 mg的目标剂量治疗。在所有剂量组中均观察到了高比例的PSA应答率和显著的PSA水平下降：100%的患者达到PSA 50标准，63%的患者达到PSA 90，31%的患者达到PSA 99。在目标剂量≥2 mg时，PSA下降具有持久性：75%的患者在≥12周内维持PSA 50，50%的患者在≥12周内维持PSA 90。不论患者的耐药驱动基因状态或是否接受过紫杉烷类药物或其它药物治疗，均观察到了深度且持久的PSA应答。在可按RECIST评估的患者中，观察到抗肿瘤活性，50%（4/8）的患者出现确认或未确认的部分缓解。安全性方面，JANX007耐受性良好，细胞因子释放综合征（CRS）及CRS相关的不良事件主要局限于治疗第一个周期，且为1级和2级。同样，与治疗相关的不良事件（TRAEs）主要也局限于第一个周期，且为1级和2级。目前尚未达到JANX007的最大耐受剂量。 DFP-17729：公布1/2a期临床试验的新数据 Delta-Fly Pharma公司宣布，DFP-17729联用TS-1或TS-1单药作为晚期胰腺癌患者的三线后治疗的2/3期临床试验已获日本医药品医疗器械综合机构（PMDA）批准。DFP-17729是一种新型方法，旨在中和酸性的肿瘤微环境。该公司首先评估了DFP-17729作为难治性胰腺癌的治疗方法，未来将寻求把其适应症扩展到其他类型的癌症。在针对晚期胰腺癌患者的1/2期研究中，与对照治疗（TS-1或吉西他滨）相比，接受DFP-17729联用TS-1作为三线或三线以上治疗超过6周的患者的中位OS有显著延长（9.0个月对比6.1个月）。此外，在接受DFP-17729治疗的胰腺癌患者中，尿液碱化与中位OS之间存在显著相关性，可作为关键的概念验证。 MBX 2109：公布1期临床试验数据 MBX Biosciences公司宣布在The Journal of Clinical Endocrinology and Metabolism杂志上发表了其候选疗法MBX 2109的1期研究结果。MBX 2109是其基于精确内分泌肽（PEP）平台开发的甲状旁腺激素（PTH）多肽前药，能够以一周一次的给药频率，提供长效的PTH活性，旨在作为治疗甲状旁腺功能减退症（HP）的潜在长效激素替代疗法。此药物于2022年7月获得美国FDA的孤儿药资格，用于治疗HP。此次公布的结果显示，MBX 2109的前药和活性药物的半衰期均较长，分别为79-95小时和184-213小时，支持每周一次的给药频率。每周给药后，药物在体内的浓度变化相对平稳，峰谷比值根据给药剂量的不同在1.47到1.79之间。此外，观察到与剂量成正比增加的白蛋白调整后的血清钙浓度以及内源性PTH（1-84）的抑制，这与健康受试者中预期的PTH药理学效果一致。安全性方面，MBX 2109重复给药在所有测试剂量下通常耐受性良好，大多数不良反应轻微，最常见的问题是注射部位反应，没有报告与药物剂量相关的严重不良事件或死亡。 RES-010：在荷兰启动1期临床试验 Resalis Therapeutics公司宣布启动RES-010的首次人体1期研究。RES-010是一种靶向脂质生物合成、线粒体功能和脂肪组织转化的主要调节因子miR-22的反义寡核苷酸（ASO）疗法，旨在重编程代谢途径，对肥胖和脂肪肝疾病具有持久的疾病缓解治疗作用。临床前研究表明，RES-010能减少脂肪量、保持瘦体重并增强能量消耗。RES-010以减少身体各部位（包括内脏和肝脏）的脂肪为目标，有望补充和增强现有抗肥胖药物（如GLP-1受体激动剂）的疗效，支持可持续的长期体重管理。1期临床试验将在健康、超重和中度肥胖受试者中探索RES-010的安全性、耐受性、药代动力学、药效学和疗效。 SRSD107：公布1期临床试验数据 Sirius Therapeutics公司宣布，其用于预防和治疗血栓栓塞性疾病的下一代小干扰RNA（siRNA）疗法SRSD107的1期临床试验的初步数据将在第66届美国血液学会（ASH）年会上公布。SRSD107是该公司开发的新型双链siRNA，特异性靶向编码人凝血因子XI（FXI）的mRNA并抑制FXI蛋白表达，从而阻断内在凝血途径并促进抗凝/抗血栓作用。此次公布的结果显示，SRSD107具有良好的安全性和有效性，可以预防血栓形成事件，并且不会增加出血风险，有望为需要慢性抗凝剂的患者提供只需每半年一次甚至每年一次的治疗。该公司计划在未来几个月内开始2期研究。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Revolution Medicines Provides Clinical Updates from its RAS(ON) Inhibitor Portfolio. 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临床结果免疫疗法临床3期临床2期

2024-12-02

·GlobeNewswire-Health Care

MBX Biosciences Announces MBX 2109 Phase 1 Study Results Published in The Journal of Clinical Endocrinology and Metabolism

Peer-reviewed publication features positive results from multiple ascending dose (MAD) portion of Phase 1 MBX 2109 study in healthy participantsCARMEL, Ind., Dec. 02, 2024 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the publication of a peer-reviewed article highlighting results from the Phase 1 study of MBX 2109, the Company’s parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP). The publication, titled “MBX 2109, a Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-in-Human, Randomized Trial”, was published in The Journal of Clinical Endocrinology and Metabolism (JCEM) and can be accessed here. “We are pleased to have published results from our Phase 1 MAD study of MBX 2109 in JCEM, a leading peer-reviewed journal of endocrine and metabolic research,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “MBX 2109’s long half-life and flat exposure profile demonstrated in the Phase 1 study may lead to a more consistent therapeutic effect and minimize symptoms from large fluctuations in calcium compared to PTH agonists with a shorter half-life. These results, combined with its safety profile to date and pharmacodynamic activity, support the continued development of MBX 2109 as a potential once-weekly PTH prodrug for the treatment of HP. We look forward to completing enrollment in our Phase 2 Avail™ trial of MBX 2109 in patients with HP in the first quarter of 2025 and reporting topline results in the third quarter of 2025.” The publication features results from the multiple ascending dose portion of the Phase 1 study of MBX 2109, a peptide prodrug yielding a biologically active PTH agonist. The Phase 1 study was a randomized, double-blind, placebo-controlled trial designed to evaluate safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MBX 2109 in healthy adults. Forty participants were randomized 4:1 to receive four once-weekly subcutaneous doses of either placebo or MBX 2109 at 200, 400, 600, or 900 µg. Key highlights from the publication: The observed half-lives of the prodrug (79-95 hours) and the active drug (184-213 hours) reflected the prodrug design and were supportive of once-weekly administration.Peak-to-trough exposures to the active drug with weekly dosing were relatively flat, with ratios ranging from 1.47 and 1.79 across dose levels.With weekly injections, dose-proportional increases in albumin-adjusted serum calcium and concomitant suppression of endogenous PTH(1-84) were observed, consistent with the expected PTH pharmacology in healthy participants.Repeat doses of MBX 2109 were generally well-tolerated at all doses tested.Most treatment emergent adverse events (TEAEs) were mild in severity. Injection-site reaction was the most common TEAE.No MBX 2109 dose-related serious or severe adverse events or deaths were reported. About HypoparathyroidismHP is a rare endocrine disease caused by a deficiency of PTH released by the parathyroid glands that results in decreased calcium levels in the blood leading to hypocalcemia. Hypocalcemia can result in a variety of acute symptoms, such as muscle cramping or spasm, tingling, and neurological symptoms such as depression, confusion and cognitive impairment. More serious complications can occur, including seizures and cardiac arrhythmias. As a result, HP can interfere with daily activities, negatively impacting the quality of life for patients and we estimate that HP affects approximately 120,000 people in the United States and more than 250,000 in the United States and Europe. The most common cause for HP, in approximately 75% of cases, is the inadvertent removal or damage to the parathyroid glands during neck surgery. It can also be caused by certain autoimmune processes and genetic conditions. The current standard of care for HP does not address the PTH deficiency, which is the underlying cause of the disease. To avoid hypocalcemia and its symptoms due to PTH deficiency, the current standard of care consists primarily of high doses of oral calcium supplements and active vitamin D. About MBX 2109MBX 2109 is a parathyroid hormone peptide prodrug that is designed as a potential long-acting hormone replacement therapy for the treatment of HP. Leveraging the company’s proprietary Precision Endocrine Peptide™ (PEP™) platform technology, MBX 2109 was designed to provide convenient, once-weekly administration and a continuous, infusion-like PTH exposure with lower daily peak-to-trough ratios than observed with daily PTH dosing regimens. MBX 2109 received orphan drug designation from the U.S. Food and Drug Administration for the treatment of HP. About MBX BiosciencesMBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn. About MBX’s Proprietary Precision Endocrine Peptide (PEP™) PlatformMBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: MBX Biosciences’ expectations regarding the Phase 2 Avail™ trial of MBX 2109, including the timing of enrollment of patients and topline results; and statements relating to MBX 2109’s clinical profile, including the potential to be a once-weekly PTH prodrug for the treatment of HP. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect MBX Biosciences’ business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; uncertainties relating to preclinical and clinical development activities; the risk that preliminary results may not be indicative of later results; the Company’s dependence on third parties to conduct clinical trials; MBX Biosciences’ ability to attract, integrate and retain key personnel; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; as well as other risks described in “Risk Factors,” in MBX Biosciences’ Registration Statement on Form S-1 filed with the Securities and Exchange Commission (SEC), most recent Quarterly Report on Form 10-Q, as well as subsequent filings with the SEC. MBX Biosciences expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. MBX uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Media Contact:Kate BurdickInizio Evoke Commskate.burdick@inizioevoke.com 860-462-1569 Investor Contact:Jim DeNikeMBX Biosciencesjdenike@mbxbio.com

临床1期孤儿药临床结果临床2期

2024-11-18

·GlobeNewswire-Health Care

MBX Biosciences Announces Last Subject Last Visit in Phase 1 Trial of MBX 1416 for the Treatment of Post-Bariatric Hypoglycemia

Topline results expected in early January 2025CARMEL, Ind., Nov. 18, 2024 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the completion of the last subject’s last visit in its Phase 1 single and multiple ascending dose trial of MBX 1416, the Company’s long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist in development for the treatment of post-bariatric hypoglycemia (PBH). “We are pleased to complete the last subject visit in our Phase 1 trial of MBX 1416 in healthy adults and extend our sincere appreciation to the participants, investigators and clinical team for their support,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “This achievement is a significant milestone in our MBX 1416 program, bringing us closer to treating patients with PBH, for which there are no approved therapies. We look forward to sharing full-topline results in early January 2025.” The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 1416 in healthy adult participants. The trial is being conducted in the United States and enrolled a total of 69 participants. The primary endpoint is safety and tolerability, and secondary endpoints include pharmacokinetics and pharmacodynamics. More information on the Phase 1 study can be found at www.clinicaltrials.gov, identifier NCT06036784. About MBX 1416MBX 1416 is an investigational long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist in development as a potential treatment for PBH. It was designed using the Company’s novel, proprietary PEP™ platform to prevent the occurrence of severe hypoglycemia in individuals with PBH so they can lead healthier and more independent lives. About Post-Bariatric HypoglycemiaPost-bariatric hypoglycemia (PBH) is a rare and serious complication of bariatric surgery. PBH is characterized by repeated episodes of symptomatic hypoglycemia, triggered by exaggerated secretion of GLP-1 levels following a meal, and can present as early as six months after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy. Hypoglycemic episodes can occur multiple times per day and can periodically manifest with severe symptoms, such as dizziness, confusion, loss of consciousness or seizure. The unpredictability of hypoglycemic episodes and their associated risks may meaningfully hinder daily activities. As a result, the patient burden can be substantial, and many individuals cannot drive, work or live alone. To date, there are no approved pharmacotherapies to treat PBH. As the use of surgery to address metabolic conditions continues to rise, the incidence of PBH is expected to increase, reinforcing the need for safe and effective therapies. About MBX BiosciencesMBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn. About MBX’s Proprietary Precision Endocrine Peptide (PEP™) Platform MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: MBX Biosciences’ expectations regarding the Phase 1 trial of MBX 1416, including the timing of topline results and statements relating to the ability of MBX 1416 to treat patients with PBH. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect MBX Biosciences’ business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; uncertainties relating to preclinical and clinical development activities; the risk that preliminary results may not be indicative of later results; the Company’s dependence on third parties to conduct clinical trials; MBX Biosciences’ ability to attract, integrate and retain key personnel; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; as well as other risks described in “Risk Factors,” in MBX Biosciences’ Registration Statement on Form S-1 filed with the Securities and Exchange Commission (SEC), most recent Quarterly Report on Form 10-Q, as well as subsequent filings with the SEC. MBX Biosciences expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. MBX uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Media Contact:Kate BurdickInizio Evoke Commskate.burdick@inizioevoke.com 860-462-1569 Investor Contact:Jim DeNikeMBX Biosciencesjdenike@mbxbio.com

临床1期临床2期

100 项与 MBX-2109 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
甲状旁腺功能减退症	临床2期	美国	MBX Biosciences, Inc.初创企业	2024-08-08
甲状旁腺功能减退症	临床2期	阿根廷	MBX Biosciences, Inc.初创企业	2024-08-08

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05158335 (Pubmed) 人工标引	临床1期	甲状旁腺功能减退症	40	MBX 2109	餘艱壓鹹淵壓網鹹夢鑰(糧襯夢築廠鏇壓淵鬱膚) = 餘廠觸鏇構鹽醖衊簾鏇齋遞廠鏇鏇繭獵廠範願 (製醖襯蓋繭鹹衊壓襯壓 ) 更多	积极	2024-11-22
				Placebo	餘艱壓鹹淵壓網鹹夢鑰(糧襯夢築廠鏇壓淵鬱膚) = 蓋網襯獵選鑰構衊觸膚齋遞廠鏇鏇繭獵廠範願 (製醖襯蓋繭鹹衊壓襯壓 )
NEWS 人工标引	临床1期	-	76	MBX 2109	簾窪餘鹹網範衊蓋簾艱(夢糧壓獵遞蓋膚窪糧憲) = the majority of treatment emergent adverse events were mild in severity. No MBX 2109 dose-related serious or severe adverse events, or deaths were observed 淵鑰願廠壓齋壓壓鏇獵 (醖淵衊遞齋壓蓋憲憲窪 )	积极	2023-10-16
				placebo