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Altimmune Granted Fast Track Designation by FDA for Pemvidutide for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
GAITHERSBURG, Md., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S.
About this update from Altimmune, Inc.
[{"type":"text","content":"GAITHERSBURG, Md., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today 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 FDA’s decision was informed by the results of Altimmune’s studies including its Phase 1b randomized, placebo-controlled study of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD), which showed class-leading relative reductions in liver fat and non-invasive markers of hepatic inflammation and a favorable safety and tolerability profile,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “The Fast Track designation reflects Altimmune’s commitment to patients with NASH and efforts to find safe and effective treatments for this condition.” 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. In addition to IMPACT, the efficacy and safety of pemvidutide in obesity is being evaluated in MOMENTUM, a Phase 2b, randomized, placebo-control trial that is being conducted at approximately 30 sites in the U.S. An interim analysis of 160 subjects completing 24 weeks of treatment was reported in Q1 2023, and full results of 391 subjects receiving up to 48 weeks of treatment are expected later this quarter. About Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. Activation of the GLP-1 and glucago...