Can-Fite BioPharma has obtained Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for a Phase IIb clinical trial of Namodenoson to treat metabolic dysfunction-associated steatohepatitis (MASH).

An orally bioavailable small molecule drug, Namodenoson acts on the A3 adenosine receptor, which is over-expressed on the surface of liver pathological cells in MASH and not in normal cells.

This specificity positions Namodenoson as a potentially ideal candidate for MASH treatment, the company noted.

In a Phase IIa clinical trial, Namodenoson demonstrated the ability to lower hepatic steatosis, inflammation, and fibrosis, while maintaining a robust safety profile.

Can-Fite is actively enrolling patients in the Phase IIb clinical trial in Europe and Israel.

With the IND clearance from the FDA, the company will now also be able to recruit patients in the US.

The randomised, multicentre, double-blind, placebo-controlled study will enrol subjects with biopsy-confirmed MASH.

Assessing the efficacy of Namodenoson versus placebo in 140 MASH patients is the trial’s primary efficacy objective.

Subjects eligible for the study will be randomised into a 2:1 ratio to receive either oral doses of Namodenoson 25mg every 12 hours or a placebo for a period of 36 weeks.

Can-Fite BioPharma CEO Motti Farbstein said: “The IND activation for the treatment of MASH patients with Namodenoson, opens the gate for the enrolment of US based patients and will contribute to the heterogeneity of the population of this study.

“As we are already enrolling patients for this study, we hope that in the next few months, we will complete recruitment. We are committed to improve the lives of MASH patients and based on the efficacy of the drug in the Phase IIa study, we are proud to develop a new potential treatment to address this disease.”

In August last year, the company submitted a plan to the US FDA to conduct a paediatric study of Piclidenoson for treating adolescents with psoriasis.