Clinical DevelopmentAltimmune announced completion of an end-of-Phase 2 meeting with FDA, attaining agreement on the design of a Phase 3 registrational program for pemvidutide in obesity that is expected to include four Phase 3 trials, VELOCITY-1, -2, -3, and -4.
Market PotentialAltimmune plans to submit IND applications for pemvidutide in up to three additional indications, potentially expanding to more patient populations.
Safety And EfficacyThe FDA confirmed there were no safety signals for pemvidutide, allowing the focus to be on its key efficacy attributes such as weight loss and lipid reduction.