Can-Fite Completes 247-Patient Phase 3 Psoriasis Enrolment, Interim Data Due Q4 2026/Q1 2027
CANF•Can-Fite completed enrolment of 247 patients in its pivotal Phase 3 psoriasis trial under FDA- and EMA-agreed protocol, advancing to the pre-specified interim analysis stage. Efficacy and safety data from this randomized, double-blind study (PASI 75 and sPGA 0/1 endpoints) are expected in Q4 2026/Q1 2027.
1. Enrollment Milestone Achieved
Can-Fite reached full enrolment of 247 patients in its pivotal Phase 3 study of Piclidenoson for moderate-to-severe plaque psoriasis. This milestone triggers the interim analysis stage defined in the FDA- and EMA-approved protocol.
2. Trial Design and Endpoints
The randomized, double-blind, placebo-controlled trial administers 3 mg Piclidenoson tablets or placebo twice daily, with co-primary endpoints assessing PASI 75 response and static Physician’s Global Assessment scores of 0 or 1 at Week 16. The study aims to demonstrate both clinical efficacy and safety for chronic treatment.
3. Next Steps and Market Potential
Interim efficacy and safety data are slated for release in Q4 2026/Q1 2027, marking a crucial regulatory step ahead of potential approval discussions. Piclidenoson’s oral dosing and favorable safety profile could position it as a differentiated option in the expanding global psoriasis therapeutics market.
