Piclidenoson - (COMFORT)
- Indication
- Psoriasis
- Stage
- phase3
- Event
- Interim Data
- Details
July 06, 2026: Can-Fite BioPharma Ltd. (NYSE: CANF; TASE: CANF) announced it has completed enrollment of the first 247 patients in its pivotal Phase 3 randomized, double-blind, placebo-controlled trial of oral Piclidenoson (3 mg tablets twice daily) for moderate-to-severe plaque psoriasis. The trial has reached the pre-specified interim analysis stage under a protocol agreed with both the FDA and EMA; the interim analysis will assess efficacy and safety, with results expected in Q4 2026/Q1 2027. Co-primary endpoints are PASI 75 response and sPGA 0/1 at Week 16.
The release also notes other programs: Namodenoson is being evaluated in a Phase 3 trial for hepatocellular carcinoma (HCC), a Phase 2b trial in MASH, and a Phase 2a study in pancreatic cancer; it has Orphan Drug Designation in the U.S. and Europe and FDA Fast Track Designation as a second-line treatment for HCC. CF602 is described as having shown efficacy in erectile dysfunction.
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