In This Article:
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter.
Dive Brief:
-
Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people with cirrhosis due to metabolic dysfunction-associated steatohepatitis, a common disease that was formerly known as NASH.
-
Announced Monday by Akero, the study results exceeded investor expectations, more than doubling the value of shares in the biotechnology company. They also helped to push up the stock of 89bio, a competitor developing a similar type of drug to Akero’s.
-
While the Food and Drug Administration last year approved the first treatment for MASH, its use is limited to people whose livers aren’t yet cirrhotic. According to Akero, its drug is the first compound to show a significant reversal of cirrhosis due to MASH in clinical testing.
Dive Insight:
Akero’s positive results Monday represent a redemption of sorts for the company, which in late 2023 lost around $2 billion in value after data from the same trial missed an earlier bar for success.
Those data were after 36 weeks of treatment, while Monday’s findings came after 96 weeks. Over the 15 months in between, more study participants responded to Akero’s drug, called efruxifermin.
Overall, 29% of people given the highest tested dose of efruxifermin experienced improvement in liver scarring of at least one stage and no worsening of MASH — the study’s main measurement. Only 12% of those on placebo met the same criteria.
Akero also presented results from the smaller group of study participants who had liver biopsy results both at baseline and at week 96. (Some people in the trial discontinued due to side effects of treatment, withdrawn consent, doctor’s advice or were otherwise lost to follow-up.) Among this group, 39% of those on the high dose of efruxifermin had improved liver scarring without worsening of MASH, versus 15% of people given placebo.
Since the 36-week data missed the study’s primary goal, all statistical comparisons at 96 weeks are considered “nominal.”
Still, the data at 96 weeks was better than what Wall Street anticipated and, per Akero, showed how longer treatment with efruxifermin can result in better outcomes.
“We believe today’s first-ever public report of reversal of cirrhosis due to MASH ... sets [efruxifermin] apart from other approved or investigational treatments in the MASH landscape as a compound with transformational potential,” Akero CEO Andrew Cheng said in a statement.