Can Fite BioPharma, an advanced clinical stage biotechnology company ramping up pipeline of its proprietary small molecule drugs designed for inflammatory, cancer and liver diseases, has reportedly announced the enrollment of first patient in its Phase IIb study of Namodenoson for non-alcoholic steatohepatitis (NASH).

The Phase IIb clinical trial of its drug candidate Namodenoson is a randomized, multi-center, double-masked, placebo-centered study conducted in subjects diagnosed with biopsy-confirmed NASH.

Primary assessment stage of the study will focus on evaluating the efficacy of Namodenoson against that of placebo among 140 subjects with NASH, as standardized by a histological endpoint.

As a part of the study, eligible subjects are randomly aligned in 2:1 ratio, offered either 25 mg of Namodenoson dose orally every 12 hours or similar pattern of placebo for 36 weeks.

As of now, not a single NASH treatment has been approved by the U.S. FDA, while the increasing prevalence of the condition is estimated to drive the potential pharmaceutical market to approximately $35-$40 billion by 2025.

The U.S. National Institutes of Health highlights that incidences of NASH in the U.S. are seen among 2-5% of the American population.

Moreover, NASH is at the forefront of causative factors for liver transplant in women and the second to lead cause in both men and women in the U.S., notably to flag itself as the leading position in causes for liver transplants in men as well.

Dr. Pnina Fishman, CEO of Can-Fite, explained that the Phase IIa study rendered promising results associated with key liver fibrosis and NASH biomarkers and hence the biopharma anticipates similar therapeutic effect among a larger cohort of subjects tested using liver biopsy.

Currently, Can-Fite has already secured out-licensing agreements for its proprietary drug Namodenoson in the treatment of NASH in China, Eastern Europe, and South Korea, consisting of milestone payments structure along with double-digit royalties following approval and commercialization.  

Source Credit: https://www.businesswire.com/news/home/20220131005278/en/Can-Fite-Announces-First-Patient-Enrolled-in-Phase-IIb-NASH-Clinical-Trial-with-Namodenoson