Altimmune Stock Plummets After Mixed Results In Liver Disease Trial: Retail Sees 'Nothing Of Substance' To Start A Position
Altimmune, Inc. (ALT) on Thursday said that its mid-stage study of Pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) yielded mixed results, sending shares down 57% in morning trade.
Metabolic dysfunction-associated steatohepatitis (MASH) is a serious liver disease characterized by fat accumulation in the liver accompanied by inflammation and cell damage.
The trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes. F2 and F3 fibrosis refer to stages of liver fibrosis, with F2 indicating moderate scarring and F3 indicating severe scarring.
Up to 59.1% patients enrolled in the study achieved MASH resolution without worsening of fibrosis at 24 weeks, as compared to merely 19.1% for placebo.
However, the percentage of participants in the trial who achieved fibrosis improvement without worsening of MASH in an intent-to-treat analysis as compared to placebo was not statistically significant.
Furthermore, only a total of 25.8% and 24.1% of participants receiving pemvidutide 1.2 mg and 1.8 mg, respectively, achieved the endpoint of both MASH resolution and fibrosis improvement, versus 13.5% in participants receiving placebo.
Treatment with the drug, however, resulted in weight loss, with a mean weight loss of up to 6.2% in Pemvidutide-treated participants, compared to 1.0% in the placebo arm.
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, the company said.
Scott Harris, Chief Medical Officer of Altimmune, expressed optimism about the company holding an end-of-mid-stage trial meeting with the FDA in the fourth quarter of 2025 and rapid progression to late-stage trials following the data.
Pemvidutide is an investigational drug in development for the treatment of MASH, obesity, Alcohol Use Disorder (AUD), and Alcohol-associated Liver Disease (ALD).
On Stocktwits, retail sentiment around Altimmune jumped from 'bullish' to 'extremely bullish' over the past 24 hours while message volume rose from 'high' to 'extremely high' levels.
A Stocktwits user, however, opined that the fibrosis improvement data, which was the only thing“worth looking forward to”, was poor, and they see no ground to start a position.
ALT stock is down by 54% this year and by 47% over the past 12 months.
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