14th Dec, 2020– Can-Fite
BioPharma Ltd. today announced the following progress with its Namodenoson drug
candidate for non-alcoholic steatohepatitis (NASH) treatment:
1. The Company is currently engaged in
the design of a Phase IIb study for Namodenoson in the treatment of NASH. The
protocol is being developed in conjunction with leading Key Opinion Leaders
(KOLs) in NASH and liver diseases including Dr. Scott Friedman, Chief of the Division
of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York,
and Dr. Stephen A. Harrison, Medical Director of Pinnacle Clinical Research,
both of whom were involved in the design of Namodenoson’s successfully
completed Phase II study in NAFLD/NASH which achieved its efficacy endpoints.
2. Drug supply – Manufacturing of
Namodenoson for the upcoming clinical study has been completed.
3. NASH patents were issued by the U.S.
& European patent offices. Can-Fite’s NASH clinical program is now
protected by claims covering the use of the A3 adenosine receptor (A3AR), the
target of Can-Fite’s platform technology, in reducing ectopic fat accumulation
particularly in fatty liver as manifested in nonalcoholic fatty liver disease
(NAFLD) and NASH.
Namodenoson for the treatment of NASH is
licensed for distribution in Korea and China in deals that include upfront and
milestone payments.
“We accumulated very important and encouraging data from our
well-designed former Phase II study which successfully met its endpoints with
60 patients and determined the optimal dosage. The Phase IIb NASH protocol will
dose patients with 25 mg Namodenoson and will measure several safety and
efficacy endpoints including liver biopsy,” stated Can-Fite CEO Dr. Pnina Fishman.
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