Altimmune's Pemvidutide Obesity Program Gains FDA Agreement on Phase 3 Design
核心洞察
Altimmune has reached an agreement with the FDA on the design of its Phase 3 program for pemvidutide in treating obesity (搜索), marking a significant regulatory milestone.
The Phase 3 program will consist of four randomized, double-blind, placebo-controlled trials, evaluating pemvidutide over 60 weeks in approximately 5,000 subjects.
The trials will assess pemvidutide's impact on body weight, lipid levels, liver fat, and body composition, including in elderly individuals with sarcopenia (搜索).
Altimmune, Inc. has announced a successful conclusion to its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding pemvidutide, a GLP-1 (搜索)/glucagon dual receptor agonist being developed for obesity (搜索) treatment. The agreement encompasses the design of a Phase 3 registrational program.
Phase 3 Trial Design
The planned Phase 3 program will consist of four Phase 3, randomized, double-blind, placebo-controlled, parallel-group trials. Each trial will evaluate pemvidutide treatment over a 60-week period. Approximately 5,000 subjects are expected to be enrolled across the four trials. The trials will assess the safety and efficacy of pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg, with the goal of securing approval for all three doses.
The Phase 3 program is designed to leverage the key attributes of pemvidutide, including the effects of balanced GLP-1 (搜索)/glucagon dual agonism in subjects with overweight and obesity (搜索).
- VELOCITY-1: This trial will assess the effects of pemvidutide on body weight in patients with obesity or overweight without diabetes. Other endpoints will include reductions in waist circumference, serum lipids, and blood pressure.
- VELOCITY-2: This trial will assess the effects of pemvidutide on body weight and serum lipids in subjects with obesity or overweight and elevated LDL cholesterol levels. The study population will include a subset of subjects with elevated LDL cholesterol levels despite ongoing statin therapy.
- VELOCITY-3: This trial will assess the effects of pemvidutide on body weight in subjects with obesity or overweight and elevated liver fat. Excess liver fat is highly prevalent in patients with obesity and is associated with an increased risk of cardiovascular disease.
- VELOCITY-4: This trial will assess the effects of pemvidutide on body weight and body composition, including in an elderly population, with emphasis on individuals entering the study with sarcopenia at baseline. Functional measures and activities of daily living will also be assessed in this patient population.
Pemvidutide's Potential
According to Vipin K. Garg, Ph.D., Chief Executive Officer of Altimmune, pemvidutide's ability to address both obesity (搜索) and its underlying comorbidities will become increasingly important. Scott Harris, M.D., Chief Medical Officer of Altimmune, stated that the Phase 3 obesity program is designed to maximize the unique attributes of pemvidutide beyond weight loss, including its potential for lipid-lowering effects, liver fat reduction, and lean mass preservation.
Pemvidutide is a novel, investigational, peptide-based GLP-1 (搜索)/glucagon dual receptor agonist in development for the treatment of obesity (搜索) and MASH (搜索). Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH.