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Altimmune Announces Initiation of 48-week Phase 2 MOMENTUM Trial of Pemvidutide in Obesity
The Company also announces completion of enrollment in 12-week, Phase 1b trial of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD)
About this update from Altimmune, Inc.
[{"type":"text","content":"The Company also announces completion of enrollment in 12-week, Phase 1b trial of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD)\nGAITHERSBURG, Md., April 01, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has enrolled the first subject in the 48-week Phase 2 MOMENTUM trial evaluating the safety and efficacy of pemvidutide1 in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). The Company also today announced the completion of enrollment in its 12-week Phase 1b clinical trial of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD). The 48-week MOMENTUM trial is being conducted at approximately 25 sites in the United States with Dr. Lou Aronne, a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator. The randomized, placebo-controlled trial is expected to enroll approximately 320 non-diabetic subjects randomized 1:1:1:1 to receive either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo weekly for 48 weeks. 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. An interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with an expected readout in Q4 2022. “Initiation of the Phase 2 MOMENTUM obesity trial marks an important milestone in the development of pemvidutide,” stated Dr. Scott Harris, Chief Medical Officer at Altimmune. “Built on a foundation of compelling Phase 1 clinical data, we see a great potential for pemvidutide to address the serious and widespread disease of obesity and its debilitating consequences.” Results from a Phase 1 trial of pemvidutide in individuals with obesity or overweight showed that 12 weekly subcutaneous doses of pemvidutide resulted in an average weight loss of 10.3%, or approximately 20 pounds, without diet or lifestyle modification. If these effects continue over the 48-week study as anticipated, weight loss approaching or equaling those of bariatric surgery may be achieved. Side effect...