Can-Fite BioPharma completes enrolment for Piclidenoson Phase 3 study
Can-Fite BioPharma enrolled 247 patients in a Phase 3 study of Piclidenoson for psoriasis, reaching the interim analysis stage. The trial, agreed upon by the FDA and EMA, aims to demonstrate safety and efficacy with results expected in Q4 2026/Q1 2027.
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Can-Fite BioPharma has completed 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 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). Results from the interim analysis, which will evaluate efficacy and safety data, are expected during Q4 2026/Q1 2027.
The Phase 3 trial is a randomized, double-blind, placebo-controlled study designed to demonstrate clinical safety and efficacy. Patients are administered 3 mg Piclidenoson tablets or placebo orally twice daily. The co-primary efficacy objectives include the proportion of subjects achieving a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) and the proportion achieving a Static Physician's Global Assessment (sPGA) 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. It 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.
Study Details
| Parameter | Details |
|---|---|
| Study Type | Randomized, double-blind, placebo-controlled |
| Dosage | 3 mg tablets twice daily |
| Primary Endpoints | PASI 75 response; sPGA of 0 or 1 at Week 16 |
| Interim Analysis Timing | Q4 2026/Q1 2027 |
What are the potential market implications if Piclidenoson demonstrates efficacy comparable to injectable biologics?
How might the oral administration of Piclidenoson influence patient adherence and treatment preferences in psoriasis management?
What strategic partnerships or commercialization plans is Can-Fite considering ahead of the anticipated interim analysis results?
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