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GAITHERSBURG, Md. - Altimmune, Inc. (NASDAQ:ALT), a biopharmaceutical company valued at $452 million, has initiated the first subject enrollment in its Phase 2 RECLAIM trial, which is set to evaluate pemvidutide’s efficacy and safety for individuals with Alcohol Use Disorder (AUD). According to InvestingPro data, analysts maintain a strong buy consensus on the stock, with price targets ranging from $6 to $28 per share. The trial is being conducted under the guidance of Principal Investigator Dr. Henry Kranzler at approximately 15 U.S. sites.
The RECLAIM trial will assess the investigational GLP-1/glucagon dual receptor agonist, pemvidutide, which is also being studied for metabolic dysfunction-associated steatohepatitis (MASH), obesity, and alcohol liver disease (ALD). The study will enroll around 100 subjects, who will be randomized to receive either 2.4 mg of pemvidutide or a placebo weekly for a duration of 24 weeks. InvestingPro analysis shows the company maintains a strong financial position with more cash than debt and a healthy current ratio of 15.85, providing adequate resources for its clinical programs. The primary measure for the trial’s success will be the reduction in the average number of heavy drinking days per week, with secondary endpoints including changes in World Health Organization (WHO) risk drinking levels and levels of phosphatidylethanol (PEth), a biomarker of alcohol intake.
The investigational new drug (IND) application for pemvidutide in AUD was filed in December 2024 and approved by the FDA in January 2025. This development comes as a response to the significant treatment gap for AUD in the United States, where it is estimated that less than 10% of over 28 million affected individuals receive any treatment, and even fewer with the three medications currently approved.
Dr. Kranzler highlighted the urgent need for new therapies given the limited effectiveness and compliance rates of existing treatments. Altimmune’s Chief Medical Officer, Dr. Scott Harris, noted the potential of GLP-1 agents like pemvidutide to reduce alcohol cravings, referencing preclinical studies showing significant reductions in alcohol preference.
The company anticipates sharing topline data from the IMPACT Phase 2b trial of pemvidutide in MASH in the second quarter of 2025, with a Phase 2 trial for ALD expected to begin enrollment in the third quarter of 2025. While five analysts have recently revised their earnings expectations upward, InvestingPro subscribers can access over 10 additional key insights about Altimmune’s financial health and growth prospects through the comprehensive Pro Research Report, available exclusively on the platform.
This news article is based on a press release statement from Altimmune, Inc.
In other recent news, Altimmune reported its first-quarter 2025 financial results, revealing a narrower-than-expected loss. The company posted an earnings per share (EPS) of -$0.26, surpassing analyst expectations of -$0.38. Revenue for the quarter was $5 million, and Altimmune successfully raised $35 million through an ATM facility. Piper Sandler maintained its Overweight rating on Altimmune, with a $25 price target, highlighting the potential of the company’s lead candidate, pemvidutide, in the non-alcoholic steatohepatitis (NASH) market. The firm expressed optimism about the upcoming Phase 2b IMPACT trial data, anticipated to be a pivotal event for Altimmune.
The research firm emphasized pemvidutide’s promising mechanism of action, which targets the liver and has shown effects on weight loss and liver fat reduction. Piper Sandler addressed numerous investor inquiries regarding pemvidutide’s development and market potential, suggesting a strong interest in the drug’s future prospects. Altimmune continues to focus on developing pemvidutide, particularly targeting NASH, a market with significant unmet medical needs. The company anticipates a transformative year in 2025, with key developments in its pipeline, including preparations for a Phase III trial for NASH expected to commence in early 2026.
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