Altimmune has reported topline results from its Phase 2 RECLAIM trial evaluating pemvidutide, an investigational dual GLP-1/GIP receptor agonist, in patients with alcohol use disorder (AUD). The study met its primary endpoint as well as multiple key secondary endpoints, according to data released by the company.
The RECLAIM trial enrolled approximately 100 patients who were randomly assigned to receive either pemvidutide or placebo over a 24-week treatment period. Participants receiving the 2.4 mg weekly injection experienced an average reduction of 4.20 heavy drinking days per week from baseline. Heavy drinking was defined as five drinks for men and four drinks for women.
In comparison, patients in the placebo group recorded an average reduction of 2.75 heavy drinking days per week over the same period. The resulting placebo-adjusted reduction was 1.45 heavy drinking days per week. Altimmune stated that the treatment effect was “highly statistically significant” in favor of pemvidutide.
Ahead of the data release, Jefferies analysts had projected a placebo-adjusted reduction of approximately 0.9 to 1.1 heavy drinking days per week.
Secondary Endpoints Also Achieved
Beyond the primary endpoint, pemvidutide met several key secondary goals in the study. These included increasing the proportion of patients who achieved a two-level reduction in World Health Organization risk drinking levels (WHO-RDL), increasing the percentage of days involving alcohol abstinence, and improving the proportion of participants reporting no heavy drinking days during the final four weeks of treatment.
The study also showed improvements in serum phosphatidyl ethanol levels, a biomarker used to assess alcohol consumption.
The FDA validated a two-level reduction in WHO-RDL as an accepted endpoint last year. According to the agency, this endpoint provides researchers and drug developers with an additional option alongside abstinence and measures based on heavy drinking days.
Commenting on the findings, Altimmune Chief Medical Officer Christophe Arbet-Engels said the company was encouraged by the outcomes observed in the trial.
Safety Results and Next Regulatory Steps
Altimmune reported that pemvidutide demonstrated a generally favorable tolerability profile during the study. Gastrointestinal adverse events, including nausea, vomiting and constipation, occurred more frequently among patients receiving the drug.
Five participants discontinued treatment because of drug-related side effects. The company also reported one serious adverse event involving low sodium levels in the blood that was considered possibly related to treatment.
Following the Phase 2 results, Altimmune plans to request an end-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss the path forward for pemvidutide in alcohol use disorder. The company also intends to present the RECLAIM findings at a scientific meeting and submit the data for publication in a peer-reviewed journal.
“Given the known detrimental effects of alcohol on the liver, the liver-directed impact of glucagon in pemvidutide may provide further benefit in the treatment of AUD over GLP-1 alone, underscoring pemvidutide’s promising potential differentiation,” Arbet-Engels said.
Pemvidutide Development and Other AUD Programs
Pemvidutide is administered as a once-weekly injection and activates both glucagon and GLP-1 receptors. In addition to alcohol use disorder, the drug is being studied for metabolic dysfunction-associated steatohepatitis (MASH), alcohol-related liver damage, and weight loss. Altimmune previously reported Phase 2b data showing significantly improved disease resolution versus placebo in MASH.
Other companies are also advancing GLP-1-based treatments for alcohol use disorder. Eli Lilly is conducting two Phase 3 studies of its investigational GLP-1/GIP candidate brenipatide in AUD, including one trial focused on patients with moderate-to-severe disease and another without that enrollment restriction. Baseline Therapeutics, which launched in January, is advancing a weekly GLP-1 therapy for AUD and has stated plans to move into late-stage development this year.
Following the announcement of the RECLAIM results, Altimmune shares rose 10% in premarket trading.
Altimmune has announced encouraging Phase 2 clinical trial results for pemvidutide in the treatment of alcohol use disorder (AUD). The findings highlight Altimmune’s ongoing commitment to developing innovative therapies for metabolic and behavioral health conditions. The positive data provide valuable insights into pemvidutide’s potential as a novel treatment option for individuals struggling with alcohol dependence, an area where significant unmet medical needs remain.
Why the Altimmune Study Matters
The latest Phase 2 results strengthen Altimmune’s clinical development program by demonstrating the potential of pemvidutide to address alcohol use disorder through a differentiated therapeutic approach. With limited treatment options currently available, Altimmune aims to provide patients and healthcare providers with a new strategy for managing this chronic condition.
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