Shares in Akero Therapeutics (AKRO) spiked by 42% in Tuesday’s trading, and continued to rally 9% after-hours, following positive results in its Phase 2a study of efruxifermin (EFX), previously known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH). This is Akero’s lead product candidate for NASH, and is engineered to mimic the biological activity profile of native FGF21.
Notably, of the 40 treatment responders who had end-of-treatment biopsies, 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis.
In addition, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also observed across all dose groups. For instance, the 70 mg dose group achieved a statistically significant 3.7kg reduction in body weight at Week 16.
Treatment with EFX was generally reported to be well tolerated, says Akero, with only two Serious Adverse Events, one of which occurred before dosing.
NASH is a serious form of NAFLD (non-alcoholic fatty liver disease) estimated to affect 17 million Americans. It is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, and can progress to cirrhosis, liver failure and cancer. NASH is a leading cause of liver transplants in the US and Europe.
“These substantial improvements… are extremely encouraging and among the strongest biopsy results reported in NASH to date,” cheered Stephen Harrison of Pinnacle Clinical Research. “I believe Efruxifermin continues to set itself apart as one of the most promising drug candidates in NASH, with impressive histology results after just 16 weeks of treatment.”
The company previously reported that each of the 28, 50 and 70 mg EFX dose groups met the primary endpoint compared to placebo, with absolute reductions of 12, 13 and 14% of liver fat, respectively, compared with 0.3% for placebo, and relative reductions of 63, 71 and 72%, compared to 0% for placebo.
Overall shares in Akero are trading up 62% year-to-date, and analysts have a Moderate Buy consensus on the stock. That’s with an average analyst price target of $34.50 (38% upside potential). HC Wainwright analyst Ed Arce estimates the current risk-adjusted per-share value of AKR-001 for patients with NASH and F3 fibrosis at $33 (40% probability of success; $3.8B global peak revenues in 2037).
He adds that at this time, he continues to view the market potential of AKR-001 in cirrhotic NASH (BALANCED trial Cohort C) as upside to the model. (See Akero stock analysis on TipRanks).
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