primary endpoint in Phase IIa NASH study by reducing liver fat, inhibiting
fibrosis, and demonstrating anti-inflammatory effect
31th January 2022 – Can-Fite BioPharma issued a
press release, which is summarized as follows:
Can-Fite has enrolled the first patient in a Phase
IIb study of its drug candidate Namodenoson in the treatment of NASH.
The Phase IIb trial is a multicenter, randomized,
double-blind, placebo-controlled study. The primary efficacy objective of the
trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140
subjects with NASH, as determined by a histological endpoint. Eligible subjects
are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every
12 hours or a matching placebo for 36 weeks.
There is currently no U.S. FDA approved treatment
for NASH, an addressable pharmaceutical market estimated to reach $35-$40
billion by 2025 driven by increasing incidence. The U.S. National Institutes of
Health estimate the prevalence of NASH in the U.S. at 2-5% of the population.
NASH is the leading cause for liver transplants among women and second leading
cause overall in the U.S. Given the rate of increase, it is expected to become
the leading indication for liver transplants in males as well.
website link: https://ir.canfite.com/news-events/press-releases/detail/981/can-fite-announces-first-patient-enrolled-in-phase-iib-nash