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Altimmune Announces FDA Clearance of Pemvidutide (ALT-801) IND for Obesity
Enrollment in 48-week Phase 2 clinical trial expected to begin in Q1 2022 GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT),
About this update from Altimmune, Inc.
[{"type":"text","content":"Enrollment in 48-week Phase 2 clinical trial expected to begin in Q1 2022\nGAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Altimmune expects to initiate the Phase 2 trial in obesity in the first quarter of 2022. The Company previously received IND clearance for pemvidutide in NASH and is currently enrolling subjects with nonalcoholic fatty liver disease (NAFLD) in a Phase 1b trial. “This Phase 2 trial in obesity represents an important milestone toward developing a safe and effective treatment option for people with obesity,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “Results from a recently completed Phase 1 study of pemvidutide in Australia showed that 12 weekly subcutaneous doses of pemvidutide at the 1.8 mg dose level resulted in an average weight loss of 10.3% in overweight and obese subjects. Importantly, there were no study discontinuations due to adverse events. We believe these results rank among the best in terms of the rate and magnitude of weight loss and tolerability among drugs in development for obesity.” The Phase 2 clinical trial will enroll approximately 320 individuals with obesity or who are overweight with at least one obesity-related complication. Subjects will be randomized 1:1:1:1 to receive either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks. The primary endpoint of the study 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. About Pemvidutide Pemvidutide (proposed INN, formerly known as ALT-801) is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. Activation ...