Altimmune has completed dosing (last subject last dose) in its 48-week Phase 2 MOMENTUM trial evaluating the efficacy and safety of pemvidutide in subjects with obesity or overweight. Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. 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. Pemvidutide incorporates the EuPort domain, a proprietary technology that increases its serum half-life for weekly dosing while likely slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability.
MOMENTUM is a multi-centre, randomised, placebo-controlled trial that is being conducted at approximately 30 sites in the US, with Dr Louis J Aronne, Founder and Director of the Center for Weight Management at Weill-Cornell Medical Center, serving as the Principal Investigator. The primary endpoint of the trial is the relative (percent) change in body weight at 48-weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.
At the conclusion of enrolment, a total of 391 subjects with obesity or overweight and without diabetes were enrolled and randomized, the higher than planned enrolment reflecting the high enthusiasm for the trial and surge in eligible participants at final screenings. Subjects were randomized 1:1:1:1 to either 1.2mg, 1.8mg, 2.4mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
“We remain on target to announce topline 48-week results from our Phase 2 MOMENTUM trial in the fourth quarter of this year,” said Dr Vipin K Garg, President and CEO of Altimmune. “We believe pemvidutide offers a highly differentiated product profile that includes significant reductions in body weight, serum lipids and liver fat, without increases in heart rate or other cardiovascular safety signals. We also believe this combination of attributes has the potential to demonstrate best in class benefits in future cardiovascular outcome trials.”