Altimmune is expanding the clinical testing of its investigational GLP-1/glucagon dual agonist pemvidutide beyond obesity into alcohol-related disorders, positioning itself to compete with pharmaceutical giants in the rapidly evolving metabolic disease space.
During a virtual R&D event on Thursday, Altimmune revealed plans to initiate a Phase II trial of pemvidutide for alcohol use disorder (AUD) in the second quarter of 2025, followed by another Phase II trial for alcohol-related liver disease beginning in the third quarter.
The announcement sparked investor interest, with Altimmune shares rising approximately 4% following the news.
Strategic Expansion into Alcohol-Related Disorders
Altimmune executives emphasized the scientific rationale behind this expansion, highlighting the interconnection between alcohol use and obesity in causing liver damage. William Blair analysts Andy Hsieh and Alexandra Ramsey supported this approach in a note to investors, stating, "In our view, AUD and [alcohol-related liver disease] are logical extensions for evaluation of pemvidutide's efficacy, given its mechanisms of action."
The Phase II trial for alcohol-related liver disease will use liver stiffness as its primary endpoint—a non-invasive proxy for liver health that avoids the risks associated with biopsies. For the AUD study, researchers will measure the change in the number of heavy drinking days after 24 weeks of treatment as the primary endpoint.
Competitive Landscape in GLP-1 Applications
Altimmune joins several major pharmaceutical companies exploring GLP-1 based therapies for alcohol-related conditions. Eli Lilly has already advanced its GLP-1 agonist mazdutide into Phase II trials for AUD, while Novo Nordisk is evaluating semaglutide, an amylin analogue, and an FGF21 analogue for alcoholic liver disease.
This expansion reflects the growing interest in repurposing metabolic drugs for conditions beyond their original indications, potentially opening new revenue streams for companies in this space.
Promising Obesity Data
Pemvidutide has already shown significant promise in obesity treatment. Last summer, Altimmune released data from its Phase II MOMENTUM trial, demonstrating 15.6% weight loss at the highest dose. The company highlighted a key differentiator from competing obesity medications: approximately 80% of the weight loss came from fat reduction rather than lean muscle mass loss.
"The preservation of lean muscle mass could represent an important advantage for pemvidutide in the increasingly competitive obesity market," noted a clinical investigator familiar with the trial results.
Ongoing Development and Partnership Strategy
Beyond obesity and the newly announced alcohol-related disorder trials, Altimmune continues to evaluate pemvidutide in the Phase II IMPACT study for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver condition.
According to William Blair analysts, Altimmune is actively seeking a partner to help advance pemvidutide into Phase III trials, a critical step that would require significant resources. This partnership strategy could accelerate the drug's development timeline while sharing the financial burden of late-stage clinical trials.
Market Implications
The expansion into alcohol-related disorders potentially broadens pemvidutide's market opportunity significantly. Alcohol use disorder affects approximately 29.5 million adults in the United States alone, according to recent epidemiological data, while alcohol-related liver disease represents a growing health concern with limited treatment options.
If successful in these new indications, pemvidutide could establish Altimmune as a significant player in multiple high-value therapeutic areas, challenging established pharmaceutical companies that currently dominate the GLP-1 market.
