Can-Fite Completes Enrollment in Phase 3 Psoriasis Trial, Data Expected Late 2026 — Can-Fite BioPharma Ltd.

Event summary

Can-Fite BioPharma has completed enrollment of 247 patients in its Phase 3 trial for Piclidenoson, an oral treatment for moderate-to-severe plaque psoriasis.
The study is now at the interim analysis stage under a protocol agreed with both the FDA and EMA.
Results from the interim analysis are expected in Q4 2026 or Q1 2027.
Piclidenoson is an oral A3 adenosine receptor agonist, differentiating it from injectable biologic therapies.

The big picture

Can-Fite's completion of patient enrollment in its Phase 3 trial for Piclidenoson marks a critical step in the development of an oral treatment for psoriasis, a market driven by demand for safe, effective, and convenient long-term options. The study's protocol, agreed upon with both the FDA and EMA, provides a clear regulatory pathway, potentially accelerating the drug's approval process. The global psoriasis therapeutics market continues to expand, presenting a significant opportunity for Piclidenoson if it can demonstrate efficacy and safety in the upcoming interim analysis.

What we're watching

Regulatory Pathway: How the FDA and EMA-agreed protocol will influence the regulatory approval process for Piclidenoson.
Market Differentiation: Whether Piclidenoson's oral administration and favorable safety profile can position it as a strong competitor in the psoriasis therapeutics market.
Data Readout Impact: The pace at which interim analysis results could affect Can-Fite's strategic positioning and investor confidence.