Photo: Open Grid Scheduler / Grid Engine / Wikimedia Commons / CC0
DENVER, Colo. – Altimmune said Monday that its experimental drug pemvidutide cut heavy drinking days by 1.45 more days a week than placebo in a Phase 2 trial of adults with moderate-to-severe alcohol use disorder, according to detailed results the company presented at The Liver Meeting, the American Association for the Study of Liver Diseases’ annual conference in Denver. The results are company-reported. Pemvidutide is investigational and is not approved for any use.
The RECLAIM trial randomized about 100 adults with a body mass index above 25 to 2.4 mg of pemvidutide or placebo once weekly for 24 weeks, along with a standardized behavioral intervention. Heavy drinking days (five or more drinks a day for men, four or more for women) fell by 4.20 a week with pemvidutide versus 2.75 with placebo, a difference of 1.45 days (p=0.0014). The company said 42.2% of pemvidutide patients had zero heavy drinking days versus 17.4% on placebo. Participants on the drug lost 8.7% of body weight on average versus a 0.4% gain on placebo.
Gastrointestinal side effects were more common with the drug: nausea in 44% of the pemvidutide group versus 24% on placebo, vomiting 18% versus 6%, diarrhea 20% versus 10% and constipation 26% versus 6%. Altimmune called the drug generally well tolerated, with mostly mild-to-moderate adverse events. Treatment discontinuation was similar, 20% with pemvidutide and 22% with placebo.
Altimmune, based in Morristown, N.J., also presented new data from its Phase 2b IMPACT trial in MASH, a fatty liver disease. It said it has an end-of-Phase 2 meeting with the FDA scheduled for December to discuss the design of a Phase 3 trial in alcohol use disorder.
Why it matters: there is no approved drug that treats the combined metabolic and liver effects of alcohol use disorder, and the Phase 3 design is the next step toward a regulatory filing. Still unknown: whether the results hold in a larger trial, how the FDA will respond to the Phase 3 plan, and whether pemvidutide’s side effects will limit its use. The results come from the company and have not been independently reviewed here.
Archival photo: the Colorado Convention Center in Denver. The signage in the picture is from an earlier event, and the image is not from this year’s meeting or the trial.
JBizNews Desk | Denver, Colo.
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