Altimmune (ALT) Reports Positive Phase 2b Results for Pemvidutide in MASH Trial

Altimmune, Inc. (NASDAQ:ALT) is one of Goldman Sachs’ top penny stock picks. On June 26, the company reported positive topline results from its Phase 2b IMPACT trial evaluating Pemvidutide, a treatment candidate for metabolic dysfunction-associated steatohepatitis (MASH). The results mark a key milestone in advancing potential therapies for this chronic liver condition.

Altimmune (ALT) Reports Positive Phase 2b Results for Pemvidutide in MASH Trial

A biotechnologist in a lab wearing an apron and safety glasses, working on a biopharmaceutical process.

According to the company, the trial’s findings indicate that Pemvidutide is the first product candidate to demonstrate significant MASH effects and weight loss within 24 weeks. The trial achieved its primary endpoint, showing “statistically significant MASH resolution without worsening of fibrosis.” This was observed in up to 59.1% of participants in an intent-to-treat (ITT) analysis. In the ITT analysis, MASH resolution without worsening of fibrosis was achieved in 59.1% of participants treated with 1.2 mg of Pemvidutide and in 52.1% with 1.8 mg, compared to 19.1% in the placebo group (p < 0.0001 for both doses).

The trial met several secondary endpoints, including reductions in liver fat content and liver enzyme levels. As such, the company concluded that Pemvidutide has additional therapeutic benefits for MASH patients.

These positive results are expected to pave the way for Altimmune to engage with the FDA in an End-of-Phase 2 meeting. The objective will be to define the path forward, including the design and scope of a Phase 3 trial. A final readout from the 48-week treatment period is anticipated in the fourth quarter of 2025.

Altimmune, Inc. (NASDAQ:ALT) is a clinical-stage biopharmaceutical company. It develops peptide-based treatments for obesity, liver diseases, and metabolic disorders. Its lead product is Pemvidutide, a dual GLP-1/glucagon receptor agonist being tested for obesity, metabolic-associated steatohepatitis (MASH), and alcohol use disorder.

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Disclosure: None. This article is originally published at Insider Monkey.