SOUTH SAN FRANCISCO – Akero Therapeutics, Inc. (NASDAQ: AKRO), a clinical-stage biopharmaceutical company with a market capitalization of $3.38 billion, has announced in the New England Journal of Medicine the results from its Phase 2b SYMMETRY trial, which suggest that its drug efruxifermin (EFX) may improve liver fibrosis in patients with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH). The company’s stock has shown remarkable strength, delivering a 103.8% return over the past year. According to InvestingPro, five analysts have recently revised their earnings expectations upward for the upcoming period.
The trial included 182 patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to MASH. The study evaluated the efficacy and safety of EFX over 96 weeks, with a primary endpoint of ≥1-stage fibrosis improvement without MASH worsening at 36 weeks. Secondary outcomes included fibrosis improvement at week 96 and MASH resolution at both 36 and 96 weeks.
Results showed that at week 36, 19% of participants in the EFX 50mg group and 18% in the EFX 28mg group met the primary endpoint, compared to 13% for the placebo group. At week 96, 29% of the EFX 50mg group and 21% of the EFX 28mg group showed fibrosis improvement without MASH worsening, versus 11% in the placebo group. Patients who showed improvement at week 36 generally maintained their response at week 96, with additional responders observed at the later stage, particularly in the EFX 50mg group.
EFX also demonstrated improvements in noninvasive markers of liver injury and fibrosis, as well as markers of insulin sensitivity and lipid metabolism, when compared with placebo at week 96. The treatment’s safety and tolerability profile was consistent with previous trials, with most adverse events being gastrointestinal or injection site related, mild or moderate, and transient.
Kitty Yale, chief development officer of Akero, expressed optimism regarding the potential of EFX, as the company proceeds with its Phase 3 SYNCHRONY program. EFX is also being evaluated in three ongoing Phase 3 clinical studies targeting different stages of MASH. The company maintains a strong financial position with a current ratio of 19.38, indicating robust liquidity to support its clinical programs. InvestingPro analysis reveals the company holds more cash than debt on its balance sheet, providing additional financial flexibility for its development pipeline.
MASH is a serious condition that can lead to liver failure, cancer, and death, affecting an estimated 17 million Americans. There are currently no approved treatments for MASH, which is also the fastest-growing cause of liver transplants and liver cancer in the US and Europe.
This news is based on a press release statement from Akero Therapeutics.
In other recent news, Akero Therapeutics has garnered attention from analysts with updates on its stock target and rating. Clear Street initiated coverage on Akero with a Buy rating, setting a price target of $49. The firm highlighted Akero’s primary clinical asset, Efruxifermin (EFX), for its potential in treating non-alcoholic steatohepatitis (NASH), emphasizing its promising results in Phase 3 clinical trials. EFX’s efficacy, particularly in the cirrhosis stage F4, has been noted as a key differentiator in the market, with Clear Street citing its ability to significantly improve fibrosis as a crucial factor. Meanwhile, H.C. Wainwright analyst Ed Arce raised the price target for Akero to $75, maintaining a Buy rating. Arce’s analysis focuses on the potential of EFX, projecting global peak revenues of $5.8 billion by 2037 and valuing the drug’s risk-adjusted per-share at approximately $50.60. The evaluation considers the 96-week SYMMETRY study results and anticipates market exclusivity for EFX through 2037. Both firms underscore the strategic value of EFX in the NASH market, particularly for patients in advanced stages of the disease.
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