NeuroBo Pharmaceuticals has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the treatment of nonalcoholic steatohepatitis (NASH).

The Boston, US-based company’s drug candidate, DA-1241, has been shown to reduce hepatic steatosis, inflammation, and fibrosis, as well as improved lipid metabolism and glucose control regardless of body weight reduction, based on preclinical evidence generated by the company.

“We look forward to initiating the clinical development for DA-1241 and, if regulatory review of our IND is completed, key upcoming milestones for this program include enrollment of our first patient, expected in the third quarter of this year, with data targeted for the second half of 2024,” said Joe Hooker, interim president and chief executive officer of NeuroBo, in a statement.

The Phase IIa trial is expected to be a 16-week, multicentre, randomised, double-blind, placebo-controlled, parallel arm study involving 87 subjections with presumed NASH. Three cohorts will receive DA-1241 at increasing doses, and a fourth will receive a placebo. Primary endpoint is alanine transaminase (ALT) levels at week 16.

In Phase Ia/Ib clinical studies, DA-1241 was well tolerated in both healthy volunteers and patients with type 2 diabetes (T2D).

DA-1241 is a novel G-protein-coupled receptor 119 agonist, which promotes the release of key gut peptides that play roles in glucose metabolism, lipid metabolism, and weight loss. The drug can be used as combination therapy for both NASH and T2D or as a standalone.

“Filing of the IND for DA-1241 marks the first significant milestone for NeuroBo since acquiring the rights to this very promising cardiometabolic asset which is targeted to address the underserved NASH market,” Hooker added.