Altimmune’s Fatty Liver Candidate Faces Differentiation Doubts – Altimmune (NASDAQ:ALT)

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

MASH is a severe liver disease characterized by fat buildup and inflammation in the liver, which can lead to cirrhosis and liver cancer if untreated.

The Phase 2b trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes randomized 1:2:2 to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 24 weeks. 

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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).

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).

HC Wainwright reiterated a Buy rating for Altimmune with a price forecast of $12. The firm believes these data support advancing pemvidutide to Phase 3 and strengthens its case as a potential best-in-class therapy. Analyst Patrick R. Trucchio suggested the recent stock price fall was overdone, given expectations for a positive fibrosis outcome at 48 weeks.

Conversely, William Blair maintained a Market Perform rating, citing “underwhelming” results. Analyst Andy Hsieh highlighted the lack of statistically significant fibrosis improvement at the 24-week primary endpoint and expressed concerns about demonstrating stringent fibrosis improvement at the 48-week mark since no liver biopsy will be conducted. Hsieh also noted a lack of clear differentiation for pemvidutide in the increasingly competitive MASH market.

Price Action: ALT stock is trading lower by 1.80% to $3.545 at last check Friday.

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