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北京时间·🕒 发布 08-03 20:16:36时区推断·⟳ 抓取 08-03 20:17:08·⚡ 决策 08-04 10:02:25 +13h45m·84.5 天前
Altimmune启动pemvidutide治疗MASH的PERFORMA三期试验入组
PERFORMA三期包括约990人加约800人的两个队列，52周数据预计到2029年，属于长期临床推进而非近期读出。
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Altimmune begins phase 3 trial of pemvidutide for MASH
Oil falls over 4% as Trump calls off Iran strike, announces fresh talks GAITHERSBURG, Md. - Altimmune Inc. (NASDAQ:ALT)…
不做 Altimmune（ALT.US）
三期开始入组虽正面，但关键数据预计2029年，当前没有短周期可量化增量或交易edge。
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研究档案
🔎 新鲜度:最早出现 2026-08-03 · 扩散 low · price-in 风险 medium ↗
消息传播链
- 报道称Altimmune开始PERFORMA三期入组，52周读出预计2029年。
关键理由
- PERFORMA三期包括约990人加约800人的两个队列，52周数据预计到2029年，属于长期临床推进而非近期读出。
主要风险
- MASH适应症空间大，但本条只是开始入组，距离52周数据和最终监管结论仍远，短线缺少可交易里程碑。
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原文全文
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Oil falls over 4% as Trump calls off Iran strike, announces fresh talks
GAITHERSBURG, Md. - Altimmune Inc. (NASDAQ:ALT) announced Monday that it has started enrolling patients in the PERFORMA Phase 3 trial evaluating pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), according to a press release statement.
The PERFORMA trial is a global, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of pemvidutide in MASH patients with moderate to advanced fibrosis. The trial will evaluate treatment effects on fibrosis improvement, MASH resolution, and clinical outcomes.
The study includes two parallel cohorts. Cohort 1 will enroll approximately 990 patients and is designed to support the accelerated approval pathway based on a biopsy-assessed primary efficacy endpoint of MASH resolution and fibrosis improvement at 52 weeks. A second cohort will enroll approximately 800 patients with fibrosis as evidenced through non-invasive tests to add to the safety dataset. The 52-week data readout from the trial is anticipated in 2029.
Pemvidutide is an investigational balanced glucagon/GLP-1 dual receptor agonist also in development for the treatment of alcohol use disorder and alcohol-associated liver disease. The FDA granted Fast Track Designation and Breakthrough Therapy Designation to pemvidutide for the treatment of MASH.
The trial follows findings from the IMPACT Phase 2b study, where pemvidutide demonstrated MASH resolution rates, improvements in non-invasive measures of fibrosis and liver health, and weight loss. The company announced topline 48-week data from the IMPACT Phase 2b trial in December 2025.
The study will integrate the FDA-qualified AIM-MASH AI Assist tool to help standardize histological assessment of liver biopsy samples. Final regulatory approval will be based on liver-related events at approximately 60 months.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
GAITHERSBURG, Md. - Altimmune Inc. (NASDAQ:ALT) announced Monday that it has started enrolling patients in the PERFORMA Phase 3 trial evaluating pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), according to a press release statement.
The PERFORMA trial is a global, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of pemvidutide in MASH patients with moderate to advanced fibrosis. The trial will evaluate treatment effects on fibrosis improvement, MASH resolution, and clinical outcomes.
The study includes two parallel cohorts. Cohort 1 will enroll approximately 990 patients and is designed to support the accelerated approval pathway based on a biopsy-assessed primary efficacy endpoint of MASH resolution and fibrosis improvement at 52 weeks. A second cohort will enroll approximately 800 patients with fibrosis as evidenced through non-invasive tests to add to the safety dataset. The 52-week data readout from the trial is anticipated in 2029.
Pemvidutide is an investigational balanced glucagon/GLP-1 dual receptor agonist also in development for the treatment of alcohol use disorder and alcohol-associated liver disease. The FDA granted Fast Track Designation and Breakthrough Therapy Designation to pemvidutide for the treatment of MASH.
The trial follows findings from the IMPACT Phase 2b study, where pemvidutide demonstrated MASH resolution rates, improvements in non-invasive measures of fibrosis and liver health, and weight loss. The company announced topline 48-week data from the IMPACT Phase 2b trial in December 2025.
The study will integrate the FDA-qualified AIM-MASH AI Assist tool to help standardize histological assessment of liver biopsy samples. Final regulatory approval will be based on liver-related events at approximately 60 months.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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