Altimmune Achieves FDA Agreement on Phase 3 Program for Pemvidutide in Obesity Treatment
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, involving approximately 5,000 subjects over a 60-week treatment period.
The trials will evaluate pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg, aiming for approval across all three doses, while leveraging the benefits of balanced GLP-1 (搜索)/glucagon dual agonism.
Altimmune, Inc. (Nasdaq: ALT) announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 registrational program for pemvidutide, a GLP-1 (搜索)/glucagon dual receptor agonist, in the treatment of obesity (搜索).
The FDA and Altimmune aligned on key efficacy and safety measures to be studied in the Phase 3 program. The planned registrational program will include four Phase 3, randomized, double-blind, placebo-controlled, parallel-group trials, each evaluating treatment with pemvidutide over a 60-week period. Approximately 5,000 subjects are expected to enroll across the four trials. The safety and efficacy of pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg will be evaluated with the intention of obtaining approval for all three doses.
Phase 3 Trial Designs
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). The four trials are:
- 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
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. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss with class-leading lean mass preservation, and robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.
“Our interactions with the FDA regarding the Phase 3 development program have been incredibly productive, and this regulatory alignment represents a major accomplishment for our team,” said Vipin K. Garg, Ph.D., Chief Executive Officer of Altimmune. Scott Harris, M.D., Chief Medical Officer of Altimmune added, “We continue to believe that pemvidutide is highly differentiated from other incretin-based agents currently available and in development. The Phase 3 obesity (搜索) 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.”