This Biotech Company Looks To Be Targeting A New Drug To Treat NASH, The Leading Cause of Liver Transplants

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Israeli biotechnology company Can-Fite BioPharma Ltd. CANF recently enrolled the first patient in a study aimed at finding a treatment for non-alcoholic steatohepatitis (NASH), a not-so-well-known but increasingly common liver disease.

That patient will be part of a 140-strong cohort of people suffering from NASH, a disease characterized by liver inflammation and thought to affect between 2% and 5% of the U.S. population. NASH is a leading cause of liver transplants.

Can-Fite is centering the trial around its drug Namodenoson, which is currently in phase IIb. Phase IIa of the trial showed encouraging signs regarding key liver fibrosis and NASH biomarkers, the company stated.

“We hope to see a similar therapeutic effect in a larger patient population as measured by liver biopsy,” Can-Fite CEO Pnina Fishman said.

Early Encouragement?

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency have highlighted certain criteria that could give conditional approval to a drug that shows NASH resolution without worsening fibrosis (scarring) or fibrosis improvement without worsening NASH.

“We see via its mechanism of action (MOA) and preclinical models, as well as the positive impact across a broad range of noninvasive tests from the proof of concept phase IIa trial, that this drug candidate has the potential to have a significant impact on fatty liver disease,” Dr. Stephen Harrison, an expert in the field said.

Phase IIb of the Namodenoson trial will consist of oral 25-milligram doses for patients every 12 hours over a period of 36 weeks to compare with a placebo group.

Namodenoson also is headed into a phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted orphan drug designation in the U.S. and Europe and fast-track designation as a second-line treatment for HCC by the FDA.

The drug has shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma, Can-Fite says.

Can-Fite has out-licensing agreements for Namodenoson in the treatment of NASH in Eastern Europe, China, and South Korea.

The company is also working on final approval for an oral drug, Piclidenoson, to treat psoriasis, an area in which competes with major pharmaceutical providers such as Novartis AG NVS with its Cosentyx product and Amgen Inc. AMGN with Otezla.

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