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Investing.com -- Altimmune, Inc. (NASDAQ:ALT) stock fell 37% after the company announced topline results from its IMPACT Phase 2b trial of pemvidutide for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
The clinical-stage biopharmaceutical company reported that the trial met its primary endpoint, with up to 59.1% of participants achieving MASH resolution without worsening of fibrosis in an intent-to-treat analysis. Despite this positive outcome, investors appeared concerned about other aspects of the data.
The 24-week study enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3. Patients receiving pemvidutide 1.2 mg and 1.8 mg doses showed fibrosis improvement without worsening of MASH in 31.8% and 34.5% of cases respectively, compared to 25.9% for placebo - differences that were not statistically significant.
Weight loss was significant in the treatment groups, with participants receiving pemvidutide 1.2 mg and 1.8 mg achieving 5.0% and 6.2% reductions respectively versus 1.0% in the placebo group. The drug also demonstrated favorable tolerability with less than 1% of treatment discontinuations due to adverse events.
"Based on the results generated in the IMPACT trial, pemvidutide demonstrated significant MASH resolution and encouraging evidence of fibrosis improvement at 24 weeks," said Dr. Scott Harris, Chief Medical (TASE:BLWV) Officer of Altimmune. The company believes there is "a clear path to a successful End of Phase 2 meeting with the FDA in the fourth quarter of 2025."
A supplemental AI-based analysis showed statistically significant reductions in fibrosis, with 30.6% of participants receiving the 1.8 mg dose achieving a 60% or more reduction compared to 8.2% receiving placebo.
Altimmune plans to discuss the results with the FDA later this year as it prepares to advance pemvidutide to Phase 3 trials.
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