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Altimmune Announces Initiation of 12-week Phase 1b Trial of Pemvidutide in Subjects with Non-Alcoholic Fatty Liver Disease
First patient has been enrolled in 12-week non-alcoholic fatty liver disease (NAFLD) studyDr. Stephen Harrison will be serving as Principal Investigator for
About this update from Altimmune, Inc.
[{"type":"text","content":"First patient has been enrolled in 12-week non-alcoholic fatty liver disease (NAFLD) studyDr. Stephen Harrison will be serving as Principal Investigator for the studyTopline data readout expected in the first half of 2022 GAITHERSBURG, Md., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has enrolled the first patient in a Phase 1b clinical trial of pemvidutide (proposed INN, formerly known as ALT-801) in subjects with non-alcoholic fatty liver disease (NAFLD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH), the most severe form of NAFLD. The trial is being conducted at multiple sites in the United States with Dr. Stephen Harrison, a renowned expert in the field of NASH and liver diseases, serving as the Principal Investigator. This double-blind, randomized, placebo-controlled study will enroll approximately 72 diabetic and non-diabetic overweight and obese adult patients with a liver fat content greater than 10% as measured by MRI-PDFF. Pemvidutide will be administered weekly at one of three dose levels versus placebo over 12 weeks. The primary efficacy endpoint is change in liver fat content from baseline, as measured by MRI-PDFF. Secondary efficacy endpoints include weight loss, serum lipid profile, hemoglobin A1c, adiponectin, and inflammatory and fibrosis markers. The study is expected to read out topline results in the first half of 2022. Based on the findings of the NAFLD study, the Company intends to initiate a 52-week biopsy driven Phase 2 NASH study in 2022. “We are excited to initiate this NAFLD trial as we build on our recent clinical trial results in overweight and obese subjects, where we saw 10.3% weight loss at the 1.8 mg dose and positive effects on blood pressure, serum lipids and insulin resistance in only 12-weeks,” said Dr. Scott Harris, Chief Medical Officer of Altimmune. “Studies show that sustained weight loss greater than 10% leads to NASH resolution and fibrosis improvement. Meaningful weight loss, combined with the potent effects of glucagon agonism on liver fat, as observed in animal models, make a compelling case for pemvidutide in the treatment of NASH.” NAFLD is a precursor to NASH, characterized by...