Altimmune, Inc. 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. 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. 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. 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.