Altimmune's Experimental Drug Shows Promise Against Alcohol Use Disorder
Altimmune may have opened the door to a new way of treating alcohol use disorder.
The company just announced positive topline results from its Phase 2 RECLAIM trial, showing that its experimental drug, pemvidutide, significantly reduced heavy drinking in adults with moderate-to-severe alcohol use disorder (AUD).
The study met its primary endpoint and several important secondary endpoints, giving the company a strong foundation for discussions with the FDA about the next stage of development.
The 24-week study followed about 100 adults with alcohol use disorder who were also overweight or obese. Those who received a once-weekly 2.4 mg dose of pemvidutide averaged about one and a half fewer heavy drinking days each week than participants who received a placebo. That’s an encouraging result, and better than analysts were expecting going into the study.
The results went beyond the primary endpoint, too.
Turns out, more participants receiving the drug also reported no heavy drinking days during the final four weeks of treatment, which is another encouraging sign that the therapy may help people maintain healthier drinking habits over time.
This isn’t trivial, as AUD remains one of the most common (and difficult to treat) substance use disorders in the United States. According to the National Institute on Alcohol Abuse and Alcoholism, nearly 28 million U.S. adults met the criteria for AUD in 2024, yet only a small fraction receive medication as part of their treatment.
What’s next?
The drug was generally well tolerated. As expected with GLP-1 therapies, gastrointestinal side effects such as nausea, vomiting, and constipation were more common among patients receiving pemvidutide. Five participants discontinued treatment because of side effects, and one serious case of low blood sodium was considered possibly related to the drug.
Altimmune says it plans to meet with the FDA to discuss the next steps in development.
If larger clinical trials confirm these findings, pemvidutide could eventually become part of a growing class of medicines that not only treat obesity and metabolic disease but also help patients struggling with alcohol addiction; a combination that could address two major public health challenges with a single therapy.
have a look, Pemv Oral looks alive to me https://substack.com/@bambiopicks/note/c-307451589