Altimmune's Mid-Stage Pemvidutide Study Cleared By FDA For Obesity

The FDA has cleared Altimmune Inc's (NASDAQ: ALT) Investigational New Drug (IND) application for its Phase 2 trial of pemvidutide for obesity. 

• Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development to treat obesity and nonalcoholic steatohepatitis (NASH). 
• Altimmune expects to initiate the Phase 2 trial in obesity in Q1 of 2022. 
• The Phase 2 clinical trial will enroll approximately 320 individuals with obesity or overweight with at least one obesity-related complication. 
• Related: See Why Altimmune Stock Plunged After Obesity Trial Data.
• 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 study's primary endpoint 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.
• The Company previously received IND clearance for pemvidutide in NASH and is enrolling subjects with nonalcoholic fatty liver disease in a Phase 1b trial.
• Price Action: ALT shares are up 6.43% at $7.67 during the market session on the last check Monday.