Can-Fite Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol

Core Insights - The psoriasis market is projected to reach $30 billion by 2030, with a significant shift towards oral drugs [1] - Can-Fite BioPharma Ltd. has initiated a pivotal Phase 3 study for its oral drug Piclidenoson, targeting moderate to severe plaque psoriasis [1][3] Company Overview - Can-Fite BioPharma Ltd. is a biotechnology company focused on developing small molecule drugs for oncological and inflammatory diseases [1][5] - The company’s lead drug candidate, Piclidenoson, has shown efficacy in previous clinical studies and is now entering a Phase 3 trial [5] Clinical Study Details - The Phase 3 study is randomized, double-blind, and placebo-controlled, aiming to demonstrate the safety and efficacy of Piclidenoson [2] - Co-primary efficacy objectives include achieving a Psoriasis Area and Severity Index (PASI) score response of ≥75% and a Static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 16 [2] Drug Mechanism and Profile - Piclidenoson is a first-in-class A3 adenosine receptor agonist with a strong safety profile and evidence of efficacy in earlier trials [4] - The drug works by inhibiting inflammatory cytokines IL-17 and IL-23 and inducing apoptosis in skin cell keratinocytes [4]