GAITHERSBURG, Md., July 28, 2026
Altimmune, Inc. announced positive topline results from its Phase 2 RECLAIM clinical trial evaluating pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). The study successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in heavy drinking days compared with placebo. The trial also achieved multiple important secondary endpoints, including two-level reductions in World Health Organization (WHO) Risk Drinking Levels, zero heavy drinking days, increased days of abstinence, and significant reductions in phosphatidylethanol (PEth), an objective biomarker of alcohol consumption. The treatment showed a generally favorable safety and tolerability profile, prompting the company to plan an End-of-Phase 2 meeting with the U.S. FDA to discuss the future development pathway for pemvidutide in AUD.
Pemvidutide Demonstrates Strong Efficacy Across Multiple Clinical Endpoints
The 24-week randomized Phase 2 RECLAIM trial enrolled approximately 100 patients with moderate to severe alcohol use disorder and a BMI greater than 25 kg/m², assigning participants to receive either 2.4 mg pemvidutide or placebo once weekly. Patients treated with pemvidutide experienced a significantly greater reduction in heavy drinking days, achieving the study’s primary endpoint with a p-value of 0.0014. Additionally, 64.4% of treated participants achieved a two-level reduction in WHO Risk Drinking Levels, compared with 34.8% in the placebo group. Nearly 42.2% of patients receiving pemvidutide reported zero heavy drinking days during the final weeks of treatment, while meaningful improvements were also observed in abstinence rates, PEth biomarker levels, and body weight, with a 9.1% placebo-adjusted reduction at Week 24. These findings support pemvidutide’s potential to address both alcohol dependence and associated metabolic complications.
Safety Profile Supports Continued Clinical Development
Pemvidutide demonstrated a generally favorable tolerability profile, with most adverse events classified as mild to moderate. Gastrointestinal events such as nausea, vomiting, diarrhea, and constipation occurred more frequently than placebo but remained manageable, aided by a simplified two-step dose titration strategy. Serious adverse events were uncommon, with only one treatment-related serious adverse event reported. Importantly, treatment discontinuation rates were similar between the pemvidutide and placebo groups. Investigators noted that the balanced glucagon/GLP-1 mechanism may offer unique advantages by addressing alcohol cravings, liver health, and metabolic dysfunction, differentiating pemvidutide from currently available therapies for AUD.
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Altimmune Advances Toward Late-Stage Development
Following the encouraging RECLAIM results, Altimmune plans to request an End-of-Phase 2 meeting with the FDA to discuss the regulatory pathway for pemvidutide in alcohol use disorder. The company also intends to present the complete clinical findings at upcoming scientific conferences and publish the data in a peer-reviewed journal. Beyond AUD, pemvidutide is being developed for metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease (ALD), where it has already received FDA Fast Track Designation for both MASH and AUD and Breakthrough Therapy Designation for MASH. With the Phase 3 PERFORMA trial in MASH expected to begin in the third quarter of 2026 and the RESTORE Phase 2 trial in ALD continuing enrollment, the positive RECLAIM results further strengthen pemvidutide’s potential as a multi-indication therapy targeting serious liver and metabolic diseases.
Source: Altimmune, press release
