Altimmune, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program investigating pemvidutide for the treatment of NASH. NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. NASH is a growing public health concern, and there are currently no approved treatments.

The Fast Track designation is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical needs. The efficacy and safety of pemvidutide in NASH are being evaluated in IMPACT, a Phase 2b randomized, placebo- controlled biopsy-driven trial that is being conducted at approximately 60 sites in the U.S. Approximately 190 subjects with and without diabetes are being enrolled. Key efficacy endpoints are NASH resolution and fibrosis improvement at 24 weeks of treatment, with subjects followed for an additional 24 weeks to a total of 48 weeks for safety and biomarker responses.

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. Glucagon is also recognized as having direct effects on hepatic fat metabolism, leading to rapid reductions in levels of liver fat. Pemvidutide incorporates the EuPort(TM) 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.