Altimmune Successfully Completes Phase 2 Meeting with FDA for Pemvidutide in Obesity Treatment

Altimmune, Inc., a clinical-stage biopharmaceutical firm, has successfully completed its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA). The meeting confirmed the design for a Phase 3 registrational program for their product candidate, pemvidutide, aimed at treating obesity. Vipin K. Garg, Ph.D., CEO of Altimmune, highlighted the productive interactions with the FDA and emphasized the potential of pemvidutide to address obesity and its related comorbidities. He expressed optimism that achieving this regulatory milestone will aid in advancing the company's partnering efforts and preparing for additional indications.

The interaction with the FDA involved a thorough review of preclinical and clinical data from six completed clinical trials of pemvidutide. The planned Phase 3 program will consist of four randomized, double-blind, placebo-controlled, parallel-group trials, each evaluating the effects of pemvidutide over a 60-week period. This program will enroll approximately 5,000 subjects across the four trials, assessing the safety and efficacy of pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg, aiming to gain approval for all three doses.

The design of the Phase 3 trials aims to leverage the unique attributes of pemvidutide, which includes balanced GLP-1/glucagon dual agonism in individuals who are overweight or obese. The trials are as follows:

- VELOCITY-1: This trial will focus on the impact of pemvidutide on body weight in patients with obesity or overweight without diabetes, with secondary endpoints including reductions in waist circumference, serum lipids, and blood pressure.
- VELOCITY-2: This trial will evaluate the effects of pemvidutide on body weight and serum lipids in patients with obesity or overweight and high LDL cholesterol levels, particularly in subjects whose LDL levels remain elevated despite statin therapy.
- VELOCITY-3: This trial will investigate the effects of pemvidutide on body weight in subjects with obesity or overweight who also have elevated liver fat, a condition associated with increased cardiovascular disease risk.
- VELOCITY-4: This trial will assess the effects of pemvidutide on body weight and body composition, including in elderly individuals, focusing on those with sarcopenia at the start. Functional measures and daily living activities will also be evaluated.

Scott Harris, M.D., Chief Medical Officer of Altimmune, expressed satisfaction with the FDA meeting's outcomes. He highlighted the distinct features of pemvidutide compared to other incretin-based agents, particularly its potential benefits beyond weight loss, such as lipid-lowering effects, liver fat reduction, and preservation of lean mass.

Pemvidutide is described as a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist, developed to treat obesity and MASH (Metabolic Associated Steatohepatitis). The dual activation of GLP-1 and glucagon receptors is believed to simulate the complementary effects of diet and exercise on weight loss, with GLP-1 reducing appetite and glucagon increasing energy expenditure and influencing liver fat metabolism. In clinical trials, once-weekly pemvidutide has shown significant weight loss, preservation of lean mass, and reductions in triglycerides, LDL cholesterol, liver fat content, and blood pressure. The FDA has granted Fast Track designation to pemvidutide for treating MASH. The drug has completed the Phase 2 MOMENTUM obesity trial and is currently being evaluated in the Phase 2b IMPACT trial for MASH.

Altimmune is focused on developing next-generation peptide-based therapeutics, with pemvidutide being one of their key candidates aimed at addressing obesity and MASH.