Altimmune is scheduled to meet with the U.S. Food and Drug Administration (FDA) in December to discuss the design of a Phase 3 clinical programme for pemvidutide, its glucagon/GLP-1 dual receptor agonist being investigated for alcohol use disorder (AUD). The planned meeting follows findings from a Phase 2 study in which the candidate demonstrated a reduction in heavy-drinking days among participants receiving treatment.
The biotechnology company presented additional findings from its Phase 2 RECLAIM trial on Monday at the American Association for the Study of Liver Diseases (AASLD) meeting in Denver. Approximately 100 individuals with AUD were randomly assigned to receive either pemvidutide or a placebo once weekly over 24 weeks. Participants in both groups also received a standardized behavioural intervention.
The study achieved its primary endpoint, according to topline results released by Altimmune in July. During weeks 21 to 24, participants receiving pemvidutide experienced an average reduction of 4.2 heavy-drinking days per week compared with their baseline measurements. The placebo group recorded a corresponding reduction of 2.75 days per week. Altimmune described the difference as highly statistically significant.
Serum Biomarker Findings Support Clinical Results
Additional findings from the trial concerned serum phosphatidylethanol (PEth), a direct biomarker of alcohol consumption. Data disclosed in July showed that serum PEth levels declined by 38% among participants receiving pemvidutide, compared with a 5.9% increase in the placebo group.
William Blair analysts identified this result as the “strongest validation for pemvidutide in this indication” in a note to investors.
The analysts also assessed the findings in relation to an earlier Phase 2 study of semaglutide, while acknowledging the limitations of comparisons between separate clinical trials. That study, conducted in February 2025, evaluated semaglutide, a GLP-1 receptor agonist marketed by Novo Nordisk as Ozempic and Wegovy. Among 48 participants who received weekly treatment for nine weeks, heavy-drinking days declined from two to fewer than one per week.
FDA Discussions and Competing Clinical Programmes
Altimmune has arranged an end-of-Phase 2 meeting with the FDA next month to discuss the design of a registrational Phase 3 programme evaluating pemvidutide in AUD.
Eli Lilly is also investigating an incretin-based candidate for the condition. Last year, the pharmaceutical company initiated two Phase 3 trials of brenipatide, a GLP-1/GIP receptor agonist, in adults with AUD. Each study is designed to enrol 1,100 participants and examine whether 56 weeks of treatment changes their drinking patterns. According to the federal clinical trial database, the studies are expected to conclude in early 2028.
William Blair analysts noted the size and duration of Lilly’s studies when discussing the financial requirements for Altimmune’s proposed programme. They indicated that the biotechnology company would need additional capital to support a pivotal AUD programme.
Pemvidutide’s Development in Liver Disease
Altimmune reported having $519 million in cash, cash equivalents and investments at the end of June. The company has also recently initiated a Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH), a liver disease.
Although William Blair analysts believe pemvidutide has demonstrated therapeutic activity in MASH, they questioned whether the Phase 2b findings establish clear clinical differentiation. They also highlighted increasing competition in the MASH market, with Madrigal Pharmaceuticals’ Rezdiffra and Novo Nordisk’s Wegovy already in the market, while Boehringer Ingelheim and Eli Lilly continue advancing their respective candidates through clinical development.
Altimmune Prepares for an Important FDA Discussion
Altimmune is preparing to discuss the future development of pemvidutide with the U.S. Food and Drug Administration. The planned End-of-Phase 2 meeting, scheduled for December 2026, will focus on the potential design of a Phase 3 registrational program for alcohol use disorder (AUD). Altimmune
The discussion represents an important step for Altimmune as the company works to advance pemvidutide, an investigational dual glucagon/GLP-1 receptor agonist. The FDA has also granted pemvidutide Fast Track designation for the treatment of AUD. altimmune.com
Pemvidutide Shows Promise in Alcohol Use Disorder
Altimmune reported positive results from the RECLAIM Phase 2 trial, where pemvidutide achieved its primary endpoint of reducing heavy drinking days. The study also produced positive results across important secondary measures, supporting further clinical development.
