Globenewswire·2025-03-24 13:00Industry Overview - The psoriasis market is projected to reach $30 billion by 2030, with a significant shift towards oral drugs [1] Company Developments - Can-Fite BioPharma Ltd. has initiated a pivotal Phase 3 study for its oral drug Piclidenoson, targeting moderate to severe plaque psoriasis, with patient enrollment starting in Europe and expected to follow in the US and Canada [1][3] - The Phase 3 study is randomized, double-blind, and placebo-controlled, focusing on the safety and efficacy of Piclidenoson, with co-primary efficacy objectives including achieving a PASI score response of ≥75% and a sPGA score of 0 or 1 at Week 16 [2] - The FDA has requested two Phase 3 studies and encouraged the enrollment of adolescent patients due to the drug's strong safety profile [2] - Upon successful completion of the Phase 3 program, the company plans to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Plan (MAA) to the EMA [3] Product Information - Piclidenoson is a first-in-class A3 adenosine receptor agonist, demonstrating an excellent safety profile and efficacy in previous clinical studies, targeting inflammatory cytokines IL-17 and IL-23 [4] - Can-Fite's lead drug candidate, Piclidenoson, is part of a broader pipeline that includes other drugs like Namodenoson, which is being evaluated for various cancers and has received Orphan Drug Designation and Fast Track Designation from the FDA [5]