Altimmune Announces Initiation of Phase 2b IMPACT Trial Evaluating the Efficacy and Safety of Pemvidutide in Non-Alcoholic Steatohepatitis (NASH)
This randomized, placebo-controlled biopsy-driven trial is being conducted at approximately 60 sites in
Results from a blinded, 24-week Phase 1b trial of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD) showed a greater than 75% relative reduction in liver fat and 19% relative reduction in liver volume, with over 50% of the subjects achieving normalization of liver fat at the 1.8 mg dose. In addition, significant reductions in serum alanine aminotransferase (ALT) and MRI-based corrected T1 (cT1) were observed, both established markers of liver inflammation. Glycemic control was maintained, with trends toward improvements in fasting glucose and HbA1c in subjects with diabetes. Subjects on 1.8 mg pemvidutide also achieved a mean weight loss of 6.2%, with continuing weight loss at the end of treatment. Preclinical studies have shown pemvidutide to have anti-fibrotic effects in animal studies.
“Initiation of the IMPACT Phase 2b trial represents an important milestone in the development of pemvidutide for NASH,” said
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 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 EuPortTM 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.
Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation therapeutics for the treatment of patients with liver diseases and obesity. The Company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell™, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. For more information, please visit www.altimmune.com.
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the timing of the data readout of the Phase 2b IMPACT trial of pemvidutide in NASH and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to
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