Key Highlights

  • ALT shares rose 9.85% pre-market to $3.25, building on a 6.86% gain in the prior session that closed at $2.96.
  • The company reported positive topline results from its Phase 2 RECLAIM trial of pemvidutide in moderate to severe alcohol use disorder, meeting its primary endpoint of reduced heavy drinking days.
  • Pemvidutide showed a statistically significant treatment effect of negative 1.45 heavy drinking days per week versus placebo, with a p-value of 0.0014.
  • Nearly two-thirds of patients treated with pemvidutide achieved a two-level reduction in WHO Risk Drinking Levels, versus 34.8% on placebo.
  • Altimmune plans to request an End-of-Phase 2 meeting with the FDA based on the trial results.

Phase 2 Trial Meets Primary and Secondary Endpoints

Altimmune (NASDAQ:ALT) shares surged in pre-market trading on Tuesday after the company announced positive topline results from its Phase 2 RECLAIM trial evaluating pemvidutide, an investigational balanced glucagon and GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder. The trial met its primary endpoint, showing a highly statistically significant reduction in heavy drinking days compared with placebo.

Altimmune is a Gaithersburg, Maryland-based late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for serious liver and metabolic diseases. Pemvidutide, the company's lead product candidate, is also advancing through Phase 3 trials for metabolic dysfunction-associated steatohepatitis, in addition to the alcohol use disorder and alcohol-associated liver disease programs.

In the RECLAIM trial, patients on pemvidutide showed a reduction of 4.20 heavy drinking days per week from baseline at week 24, compared with a reduction of 2.75 for placebo, a treatment difference of 1.45 heavy drinking days with a p-value of 0.0014. Secondary endpoints also favored pemvidutide, with 64.4 percent of treated patients achieving a two-level reduction in World Health Organization Risk Drinking Levels compared with 34.8 percent on placebo, and 42.2 percent achieving zero heavy drinking days in the final four weeks of the trial compared with 17.4 percent on placebo. The company said the drug demonstrated a generally favorable tolerability profile.

Company Plans FDA Meeting as Shares Rally

Altimmune carries a market capitalization of approximately $261.24 million and reported a trailing loss per share of $0.93. Shares have traded in a 52-week range of $2.56 to $6.44. Following the results, the company said it plans to request an End-of-Phase 2 meeting with the FDA to discuss a path forward for pemvidutide in alcohol use disorder.

The rally adds to a string of positive newsflow for Altimmune this month, with shares having already moved higher on prior updates tied to the pemvidutide program. The scale of Tuesday's move underscores investor enthusiasm for a therapeutic mechanism that management has said may offer added benefit over GLP-1 monotherapy in alcohol use disorder, given the known effects of alcohol on the liver and the liver-directed activity of glucagon.

Conclusion

Altimmune's sharp advance reflects investor optimism that pemvidutide's positive Phase 2 results in alcohol use disorder could support an expanded regulatory pathway alongside its existing metabolic disease programs. The company's planned End-of-Phase 2 meeting with the FDA will be the next milestone determining how the program advances toward late-stage development.

This article is for informational purposes only and does not constitute investment advice. Readers should conduct their own research before making financial decisions.