Can-Fite Announces Initiation Of Phase 3 Psoriasis Study for Piclidenoson With FDA And EMA; Study To Assess Clinical Safety And Efficacy; Co-Primary Endpoints Include PASI 75 And sPGA Of 0 Or 1 At Week 16; Enrolment Begins In Europe, US And Canada To Follow. The Psoriasis Market Is Estimated At $30B by 2030 And Has Shifted Significantly To Oral Drugs

Author: Benzinga Newsdesk | March 24, 2025 09:05am

Ramat Gan, Israel, March 24, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - approved clinical study protocol. The study will enroll patients with moderate to severe plaque psoriasis. Patient enrolment will be initiated in Europe and US and Canada expected to follow.

The study is a randomized, double-blind, placebo-controlled Phase 3 aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. Patients will be treated with 3 mg twice daily orally Piclidenoson tablets or placebo. The co-primary efficacy objectives of this study are the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) and the proportion of subjects who achieve a Static Physician's Global Assessment (sPGA) at of 0 or 1 at Week 16.  The FDA requested two Phase 3 safety and efficacy studies and also encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies.

"We are excited to initiate the Phase 3 study and we believe that Piclidenoson's oral dosage and excellent safety record, together with its progressive effectiveness over time, make it an ideal drug for the chronic treatment of psoriasis," stated Can-Fite CEO Motti Farbstein.

Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA.

The Psoriasis Market Is Estimated at $30 Billion by 2030 and Has Shifted Significantly to Oral Drugs

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