Altimmune's MASH Drug Shows Durable Liver, Weight Loss Gains At 48 Weeks
Altimmune Inc. (NASDAQ:ALT) on Friday shared topline results from the IMPACT Phase 2b trial of pemvidutide.
Patients had metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks.
MASH is a liver disease marked by excess liver fat (steatosis) alongside inflammation and liver cell damage.
Topline 48-week data from the IMPACT trial showed that treatment with pemvidutide achieved statistically significant improvements across treatment arms in key noninvasive tests, including Enhanced Liver Fibrosis and Liver Stiffness Measurement, versus placebo.
The data showed continued reductions from week 24 and demonstrated sustained improvement in antifibrotic activity with both treatment doses.
These are well-established markers of fibrosis and hepatic inflammation and are strongly associated with histological changes and liver-related events.
Participants receiving pemvidutide 1.2 mg and 1.8 mg achieved weight loss of 4.5% and 7.5%, respectively, vs. 0.2% of placebo-treated participants, with no plateauing at 48 weeks with the 1.8 mg dose.
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Pemvidutide-treated participants also achieved statistically significant reductions in key noninvasive measures of liver health and hepatic inflammation.
- Liver fat content: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of 45.2% and 54.7% respectively, compared to 8.2% in participants who received a placebo.
The 48-week data also maintained the favorable tolerability profile seen at 24 weeks, including a lower discontinuation rate due to adverse events than placebo.
Adverse events leading to treatment discontinuation occurred in 0% and 1.2% of patients treated with pemvidutide 1.2 mg and 1.8 mg, respectively, vs. 3.5% of participants on placebo.
Additionally, the company held a productive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which resulted in alignment on the parameters for a registrational Phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis.
With the FDA’s recent qualification of AIM-MASH AI Assist, the Agency was open to the company’s intent to integrate the use of this AI tool into the Phase 3 trial.
AIM-MASH AI Assist is intended to help standardize histologic assessment and reduce the time and resources needed for MASH drug development.
According to CEO Vipin Garg, pemvidutide will progress to a Phase 3 program in 2026.
Price Action: ALT stock is down 21.19% to $3.98 at last check on Friday.
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