Altimmune drug cuts heavy drinking in mid-stage trial for alcohol use disorder
ALT•Secondary goals and safety findings
The drug also met key secondary goals of the study, including increasing the proportion of patients who achieved a two-level reduction in World Health Organization risk drinking levels and those reporting no heavy drinking days during the final four weeks of treatment.
Pemvidutide was generally well tolerated, Altimmune said. Gastrointestinal side effects, including nausea, vomiting and constipation, were more common in the treatment group.
Five patients discontinued treatment because of drug-related side effects, while one serious adverse event, low sodium levels in the blood, was considered possibly related to the drug.
Next regulatory steps and other studies
Altimmune said it plans to seek a meeting with the U.S. Food and Drug Administration to discuss next steps.
The drug is also being tested for liver diseases including MASH and alcohol-related liver damage.
Mid-stage trial shows reduced heavy drinking
July 28 (Reuters) - Altimmune said on Tuesday its experimental drug helped patients with alcohol use disorder cut back on heavy drinking in a mid-stage trial, sending the company's shares 10% higher in premarket trading.
The drug, pemvidutide, showed a placebo-adjusted reduction of 1.45 heavy drinking days per week in the trial, which tested a 2.4 mg dose in about 100 patients with moderate to severe alcohol use disorder over 24 weeks.
Ahead of the trial results, Jefferies analysts had forecast a placebo-adjusted reduction of about 0.9 to 1.1 heavy drinking days per week.
The drug, which is also being tested for weight loss, activates both glucagon and GLP-1 receptors. Its effect on GLP-1 receptors suppresses appetite and regulates cravings, and the results could potentially expand pemvidutide's market, if it secures approval for alcohol use disorder.
