Well-Balanced: Akero Therapeutics (AKRO) Reports Encouraging NASH Trial Data
Akero Therapeutics Inc.’s (AKRO) phase IIa study of its investigational drug AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis, or NASH, has met the primary endpoint.
In the study, dubbed BALANCED, all AKR-001 dose groups, say 28mg, 50 mg, and 70 mg, met the primary endpoint, with statistically significant absolute reductions in liver fat of 12-14% at Week 12. Similarly, all the dosage groups of AKR-001 met the secondary endpoint of relative reduction in liver fat, with the 50mg and 70mg dose groups achieving more than 70% relative reductions.
After 12 weeks of treatment, patients who have achieved at least a 30% relative reduction in liver fat are eligible for an end-of-study biopsy. Across the AKR-001 dose groups, 75-85% of patients are eligible for biopsies. As of March 30, 2020, the Company noted that 25 end-of-study biopsies have been collected from a total of 50 eligible patients.
The trial enrolled 80 patients who were randomized to receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20.
The Company expects to report the top-line safety/tolerability, laboratory measures and paired biopsy data from the BALANCED study in the second quarter of this year.
However, the Company cautioned that it is still not clear how the COVID-19 pandemic will interfere with collection of the remaining biopsies and data from other scheduled clinical visits, including the safety follow-up visit at week 20.
Non-alcoholic steatohepatitis, or NASH, refers to liver inflammation due to fat buildup in the liver and is said to affect 2 to 5 percent of Americans. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD, which affects an estimated 10 to 20 percent of people in the U.S.
Currently, there are no approved drugs for NASH. Liver transplantation is the only option for NASH cirrhosis at this time. The most advanced drug candidate for NASH is that of Intercept’s (ICPT) Obeticholic acid. An FDA panel is slated to review Obeticholic acid on June 9, 2020, and a final decision is expected by June 26, 2020.
AKRO has traded in a range of $10.78 to $34.00 in the last 1 year. The stock closed Monday’s trading at $17.18, up 6.58%.
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