Altimmune, a clinical-stage biopharmaceutical company, today presented data from the 48-week Phase 2 MOMENTUM clinical trial of pemvidutide, its GLP-1/glucagon dual receptor agonist candidate, in obesity, including the results of a recently completed body composition analysis, at the American Diabetes Association’s (ADA) 84th Scientific Sessions.
“We’re pleased with the data presented at ADA that highlight the impressive lean mass preservation achieved with pemvidutide, with only 21.9% of weight loss attributable to lean mass,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune.
“The preservation of lean mass observed in this trial was better than reported historically with diet and exercise programs and greater than what has been publicly reported with other incretin weight loss drugs, where lean mass has accounted for as much as 40% of total weight loss. Preservation of lean mass, which is primarily muscle tissue, is believed to be important in maintaining healthy weight loss and physical function. We believe that the level of muscle preservation observed in the Phase 2 trial further adds to the differentiation of pemvidutide in the treatment of obesity.”
391 enrolled in trial
The trial enrolled 391 subjects with obesity, or overweight with at least one co-morbidity and without diabetes. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. A subgroup of subjects was evaluated in a body composition analysis. At Week 48, subjects receiving pemvidutide achieved mean weight losses of 10.3%, 11.2%, 15.6% and 2.2% at the 1.2 mg, 1.8 mg, and 2.4 mg doses and placebo, respectively, with a near-linear continued weight loss observed on the 2.4 mg dose at the end of treatment. The full MRI-based body composition analysis included 50 subjects who received pemvidutide and showed that subjects in the pemvidutide groups had an average lean mass loss of 21.9% with 78.1% of weight loss attributable to fat. In addition, pemvidutide resulted in robust reductions in serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate.
“Obesity is a multifactorial disease, and patients will need a variety of treatment options that fit their specific needs and comorbidities,” said Louis Aronne, M.D., Director of the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes & Metabolism at Weill Cornell Medicine and Scientific Advisor of Altimmune. “These latest findings are particularly exciting given that pemvidutide has not only demonstrated significant weight loss but an impressive ability to preserve lean mass. With its favorable safety profile to-date and the potential to drive clinically meaningful improvements in other obesity-related conditions such as dyslipidemia and hypertension, pemvidutide could offer a highly promising, long-term treatment option for multiple segments of the obese patient population to safely and effectively manage body weight.” About Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. 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, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure.
USFDA Fast track
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. About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH.