Can-Fite BioPharma Completes Enrolment Of First 247 Patients In Pivotal Phase 3 Study Evaluating Piclidenoson For Treatment Of Moderate-To-S

Interim analysis to be conducted under an FDA- and EMA-agreed protocol Ramat Gan, Israel, July 06, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE: CANF ) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced completion of enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis.

The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S.

Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The interim analysis will evaluate efficacy and safety data from the enrolled patients.

Results are expected during Q4 2026/Q1 2027.

The study is a randomized, double-blind, placebo-controlled Phase 3 trial aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis.

Patients are treated with 3 mg Piclidenoson tablets or placebo administered orally twice daily.

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.

Piclidenoson is a first-in-class oral A3 adenosine receptor (A3AR) agonist with a differentiated mechanism of action targeting key inflammatory pathways implicated in psoriasis.

Unlike injectable biologic therapies, Piclidenoson is administered orally as a tablet and has demonstrated a favourable safety profile in more than 1,500 subjects treated across clinical studies, supporting its potential use as a chronic long-term treatment.