Altimmune Stock Sinks After Mid-Stage Data From Fatty Liver Candidate

On Thursday, Altimmune, Inc. ALT released topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH).

Treatment discontinuation rates were low, with 9% of participants prematurely discontinuing treatment.

In an intent-to-treat (ITT) analysis, the proportions of participants achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% and 52.1% for pemvidutide 1.2 mg and 1.8 mg, respectively, versus 19.1% for placebo (p< 0.0001 both doses).

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In an ITT analysis, the effects on fibrosis improvement without worsening of MASH were 31.8% and 34.5% for pemvidutide 1.2 mg and 1.8 mg, respectively, compared with 25.9% for placebo (differences not statistically significant).

A supplemental AI-based analysis demonstrated statistically significant reductions in fibrosis, including 30.6% of participants receiving pemvidutide 1.8 mg achieving a 60% or more reduction in fibrosis compared to 8.2% receiving placebo.

Statistically significant changes in well-established non-invasive tests (NITs) of fibrosis were also observed compared with placebo at both doses.

Together, these data suggest strong evidence of pemvidutide’s anti-fibrotic activity in the MASH population.

At 24 weeks, mean weight loss in pemvidutide-treated participants was 5.0% and 6.2% at the 1.2 mg and 1.8 mg doses, respectively, versus 1.0% in the placebo arm (p< 0.001, both doses).

Pemvidutide also demonstrated favorable safety and tolerability, with 0.0% and 1.2% adverse events (AE) related discontinuations in the pemvidutide 1.2 mg and 1.8 mg groups versus 2.4% in the placebo group, and there were no serious adverse events (SAEs) related to study medication.

25.8% and 24.1% of participants receiving pemvidutide 1.2 mg and 1.8 mg achieved the stringent endpoint of MASH resolution and fibrosis improvement versus 13.5% in participants receiving placebo (differences not significant).

Participants receiving pemvidutide 1.2 mg and 1.8 mg achieved weight loss of 5.0% and 6.2% vs. 1.0% in placebo (p< 0.001), with the trajectory showing no plateauing at 24 weeks.

Liver fat reductions of 58.0% and 62.8% were achieved in participants who received pemvidutide 1.2 mg and 1.8 mg, respectively, vs. 16.2% in placebo participants (p< 0.001, both doses).

AEs leading to treatment discontinuation were 0.0% and 1.2% for pemvidutide 1.2 mg and 1.8 mg, respectively, vs. 2.4% in participants on placebo.

Price Action: ALT stock is trading lower by 59.9% to $3.090 at last check Thursday.

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