Akero Therapeutics announced that it has completed enrollment for a phase 2a study of AKR-001, the company’s FGF21 analog candidate for the treatment of nonalcoholic steatohepatitis, according to a press release.
“We believe NASH represents one of the single largest indications that has no approved therapy in the United States and that AKR-001 has the potential to fundamentally change important parameters of disease for people with NASH, including improved lipid profiles, improved glycemic control and reduction of liver fat,” Kitty Yale, chief development officer for Akero, said in the release. “We will have two data readouts for this trial next year and are hopeful that our approach of targeting FGF21 will provide a disease-modifying treatment for people affected with NASH.”
Investigators designed AKR-001 to mimic the biological activity profile of native FGF21. Previous study data showed that AKR-001, much like other FGF analogs under investigation, has the potential to reduce liver fat, cellular stress, inflammation, and fibrosis in patients with NASH, as well as improve cardiovascular disease risk factors.
The randomized control phase 2a BALANCED study includes 80 patients who will receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks with safety and tolerability follow-up through week 20.
Akero expects topline results in the first quarter of 2020 and a full data readout in the second quarter of 2020.