3rd June, 2021—Can-Fite
BioPharma Ltd. today announced it has received clearance from the Israeli Ministry
of Health to commence a Phase IIb study of its drug candidate Namodenoson in
the treatment of NASH. Can-Fite expects to commence enrollment in Q3 2021,
ahead of the prior expected start date of Q4 2021. The Company expects to
expand the study at additional clinical sites in Europe. A prior Phase IIa
clinical trial of Namodenoson in the treatment of NASH met study endpoints
showing anti-steatotic, anti-inflammatory, and anti-fibrotic effects.
The Phase IIb trial is a multicenter,
randomized, double-blind, placebo-controlled study in subjects with
biopsy-confirmed NASH. 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 will be
randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12
hours or a matching placebo every 12 hours for 36 weeks.
“We are very pleased to receive the Israeli Ministry of Health’s approval
to proceed with our Phase IIb NASH study. Namodenoson has the potential to
offer a safe and effective treatment for NASH with the aim of reducing liver
transplants and improving quality of life and longevity for patients,” stated
Can-Fite CEO Dr. Pnina Fishman.
NASH is a clear and urgent unmet medical need, as there currently is no
U.S. approved drug to treat the disease. As of 2016,
NASH was the leading cause for liver transplants among women and second leading
cause for liver transplants overall. NASH is expected to become the leading
indication for liver transplants in males as well. The NIH estimates the
incidence of NASH in the U.S. at 2-5% of the population.Incidence is increasing based on rising obesity rates. By 2025, the addressable pharmaceutical market for NASH is estimated to reach
$35-40 billion.
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