Altimmune enrolls first patient in ALD treatment trial

GAITHERSBURG, Md. - Altimmune, Inc. (NASDAQ:ALT), a clinical-stage biopharmaceutical company with a market capitalization of $371 million and strong liquidity position, has enrolled the first patient in its RESTORE Phase 2 trial evaluating pemvidutide for Alcohol-Associated Liver Disease (ALD), according to a company press release issued Wednesday. According to InvestingPro data, the company maintains more cash than debt on its balance sheet, with a healthy current ratio of 15.85.

The randomized, placebo-controlled trial will enroll approximately 100 patients across 34 sites. Participants will be randomized to receive either 2.4mg pemvidutide or placebo for 48 weeks. Five analysts have recently revised their earnings expectations upward for the upcoming period, according to InvestingPro analysis, suggesting growing confidence in the company’s clinical programs.

Dr. Rohit Loomba, Professor of Medicine and Director of the MASLD Research Center at the University of California, San Diego, will serve as principal investigator.

The primary endpoint is change in liver stiffness measurement by vibration controlled transient elastography at Week 24. Secondary endpoints include changes in Enhanced Liver Fibrosis score, alcohol consumption, and body weight.

Pemvidutide is a GLP-1/glucagon dual receptor agonist being developed for several conditions including Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder, ALD, and obesity.

"Of the 28 million Americans with AUD, over 6 million have progressed to ALD, a condition for which there are no approved treatments and few in development," said Dr. Loomba in the statement.

The drug previously demonstrated statistically significant reductions in liver fat and markers of fibrosis in the company’s IMPACT trial for MASH.

The U.S. FDA granted Fast Track designation to pemvidutide for the treatment of MASH. The ongoing IMPACT Phase 2b MASH trial 48-week readout is expected in Q4 2025.

Altimmune is a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases. Trading at $4.58 per share, the stock has shown significant volatility, with a 52-week range of $2.90 to $11.16. For deeper insights into Altimmune’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports, which offer expert analysis on over 1,400 US stocks.

In other recent news, Altimmune announced positive results from its Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), meeting its primary endpoint with significant MASH resolution in patients. The trial revealed that 59.1% of participants receiving the 1.2 mg dose and 52.1% receiving the 1.8 mg dose achieved MASH resolution without worsening fibrosis, compared to 19.1% with placebo. However, while some improvements in fibrosis were noted, these did not reach statistical significance. Altimmune’s drug also demonstrated notable weight loss and favorable tolerability, with minimal treatment discontinuation due to adverse events. UBS maintained a Buy rating and a $26 price target, acknowledging the mixed trial results but expressing long-term value potential for pemvidutide. H.C. Wainwright also maintained a Buy rating with a $12 target, suggesting advancement to Phase 3 trials. Citizens JMP reiterated a Market Outperform rating with a $25 target, as Altimmune prepares for further presentations on pemvidutide. The company plans to discuss these results with the FDA later this year, aiming to advance pemvidutide to Phase 3 trials.

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