Altimmune Completes Enrollment in Phase 2b IMPACT Trial of Pemvidutide for MASH
Key Insights
Altimmune has completed enrollment in its Phase 2b IMPACT trial, evaluating pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH (search)).
Top-line efficacy data from the IMPACT trial, which includes approximately 190 subjects, is anticipated in the second quarter of 2025.
The FDA has scheduled an End-of-Phase 2 meeting for Altimmune's obesity (search) program for early November 2024.
Altimmune, Inc. (Nasdaq: ALT) has announced the completion of patient enrollment in its Phase 2b IMPACT trial, designed to assess the safety and efficacy of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH (search)). The company anticipates top-line efficacy data from the trial in the second quarter of 2025. Additionally, Altimmune has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in early November 2024 to discuss its obesity (search) program and plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4 2024.
IMPACT Trial Details
The Phase 2b IMPACT trial is a biopsy-driven study involving approximately 190 subjects diagnosed with MASH (search). The primary endpoint is to evaluate the efficacy of pemvidutide in resolving MASH and improving liver fibrosis. Dr. Mazen Noureddin, M.D., MHSc, Professor of Medicine at Houston Methodist Hospital, emphasized the potential of pemvidutide, stating, "IMPACT will be the first incretin-based study to read out on a biopsy-driven fibrosis endpoint at only 24 weeks...the combination of direct liver effects and weight loss conferred by pemvidutide offers an important advantage over other approaches to the treatment of MASH."
Pemvidutide's Mechanism of Action
Pemvidutide is a novel, investigational, peptide-based GLP-1 (search)/glucagon dual receptor agonist. It is designed to mimic the effects of diet and exercise by suppressing appetite through GLP-1 receptor activation and increasing energy expenditure via glucagon receptor activation. Glucagon is also known to directly impact hepatic fat metabolism, potentially leading to rapid reductions in liver fat and serum lipids. Clinical trials have demonstrated that once-weekly administration of pemvidutide results in significant weight loss, substantial reductions in triglycerides and LDL cholesterol, decreased liver fat content, and lowered blood pressure, all while preserving lean mass. The FDA has granted Fast Track designation to pemvidutide for the treatment of MASH (search).
Future Development Plans
Altimmune is also preparing to file IND applications for pemvidutide in up to three additional indications, with the first submission expected in Q4 2024. Details regarding these indications will be disclosed following alignment with the FDA. Scott Harris, M.D., Chief Medical Officer of Altimmune, noted, "We believe we have strong scientific rationale to support the development of pemvidutide in these additional indications, all of which are areas of high unmet medical need, where we believe its balanced GLP-1 (search)/glucagon dual agonism could allow for differentiation from other approaches."
The company's strategic initiatives aim to broaden the application of pemvidutide in metabolic diseases and enhance its long-term value proposition. The End-of-Phase 2 meeting with the FDA will focus on the Phase 3 clinical development plan for pemvidutide in obesity (search), leveraging its unique attributes to benefit patients with obesity, excess liver fat, and elevated serum lipids while preserving lean mass.