Can-Fite BioPharma Ltd. (CANF), Monday announced the initiation of a pivotal Phase 3 clinical study of its oral drug, Piclidenoson, for the treatment of moderate to severe plaque psoriasis.
The study, which has an FDA and EMA-approved protocol, will enroll patients in Europe, with the U.S. and Canada expected to follow.
The randomized, double-blind, placebo-controlled study aims to demonstrate the clinical safety and efficacy of Piclidenoson.
The co-primary endpoints include achieving a Psoriasis Area and Severity Index or PASI score of =75% or PASI 75 and a Static Physician's Global Assessment or sPGA score of 0 or 1 at Week 16.
The FDA had previously requested two Phase 3 studies and encouraged the enrollment of adolescent patients due to Piclidenoson's strong safety profile.
Piclidenoson is a first-in-class, orally bioavailable anti-inflammatory drug with a proven safety record, targeting the A3 adenosine receptor.
It has shown efficacy in earlier clinical trials and is expected to be a promising treatment for chronic psoriasis.
Can-Fite plans to submit a New Drug Application or NDA to the FDA and a Marketing Authorization Application or MAA to the EMA upon the successful conclusion of the Phase 3 program.
Currently, CANF is trading at $1.62 up by 1.72 percent on the New York Stock Exchange.
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