Core Insights - Altimmune, Inc. has completed patient enrollment in the RECLAIM Phase 2 clinical trial for pemvidutide in adults with alcohol use disorder (AUD) ahead of schedule, indicating strong interest from the patient community [1][2] - The trial involves approximately 100 patients and aims to announce topline results in 2026 [1][2] - Pemvidutide is positioned as a potential therapeutic advance for AUD, targeting cravings and addressing alcohol-related liver damage [2][6] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [9] - The lead product candidate, pemvidutide, is a dual receptor agonist targeting metabolic dysfunction-associated steatohepatitis (MASH), AUD, and alcohol-associated liver disease (ALD) [9] Clinical Trials - The RECLAIM trial evaluates the safety and efficacy of pemvidutide in AUD, with a primary endpoint of reducing heavy drinking days and secondary endpoints including changes in WHO risk drinking levels and serum biomarker levels [2][8] - Concurrently, Altimmune is enrolling patients in the RESTORE Phase 2 trial for ALD [3][8] - The FDA has granted Fast Track designations to pemvidutide for both MASH and AUD, highlighting the significant unmet medical need in these areas [7] Market Context - Approximately 28 million adults in the U.S. suffer from AUD, with a significant portion presenting with comorbidities such as obesity and liver fat [5] - Current FDA-approved treatments for AUD have limited efficacy and are used by less than 2% of patients, indicating a substantial unmet need for more effective therapies [5]
Altimmune Announces Early Completion of Enrollment in RECLAIM Phase 2 Trial Evaluating Pemvidutide in Alcohol Use Disorder