Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has enrolled the first subject in the Phase 2b IMPACT trial evaluating the efficacy and safety of pemvidutide in subjects with non-alcoholic steatohepatitis (NASH). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and NASH.
This randomized, placebo-controlled biopsy-driven trial is being conducted at approximately 60 sites in the United States, with Dr. Stephen Harrison, Medical Director, Pinnacle Research, and Adjunct Professor of Medicine, Oxford University, serving as the Principal Investigator. The trial is expected to enroll approximately 190 subjects with and without diabetes randomized 1:2:2 to receive either 1.2 mg, 1.8 mg pemvidutide or placebo weekly for 48 weeks. The 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. Top-line results are expected in Q1 2025.
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.
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