RAMAT GAN, Israel, July 6, 2026
Can-Fite BioPharma announced the completion of enrollment of the first 247 patients in its pivotal Phase 3 clinical trial evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The achievement marks the pre-specified enrollment target required to initiate an interim analysis under a clinical protocol previously agreed upon with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim review will evaluate both efficacy and safety outcomes in the enrolled participants, with topline results anticipated during Q4 2026 or Q1 2027, representing a significant milestone in the global development program.
Pivotal Trial Evaluates Oral Therapy for Moderate-to-Severe Plaque Psoriasis
The ongoing Phase 3 study is a randomized, double-blind, placebo-controlled trial designed to establish the clinical efficacy and safety of oral Piclidenoson in patients with moderate-to-severe plaque psoriasis. Participants receive 3 mg Piclidenoson tablets or placebo administered orally twice daily. The trial’s co-primary efficacy endpoints include the proportion of patients achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and the proportion achieving a Static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 16. These endpoints are widely recognized by regulatory agencies as key measures of meaningful clinical improvement in psoriasis treatment.
Piclidenoson Offers Oral Alternative with Differentiated Mechanism
Piclidenoson is a first-in-class, orally administered A3 adenosine receptor (A3AR) agonist designed to target inflammatory pathways involved in psoriasis. Unlike injectable biologic therapies, Piclidenoson is formulated as an oral tablet, potentially offering greater convenience for long-term disease management. The investigational therapy works by inhibiting inflammatory cytokines, including interleukin-17 (IL-17) and interleukin-23 (IL-23), while promoting apoptosis of pathogenic keratinocytes that contribute to psoriasis progression. Across multiple clinical studies involving more than 1,500 treated participants, Piclidenoson has demonstrated a favorable safety profile, supporting its potential as a chronic treatment option for inflammatory skin diseases.
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Interim Analysis Supports Global Regulatory Development Strategy
The completion of enrollment for the interim analysis represents an important regulatory milestone for Can-Fite as it advances Piclidenoson toward potential marketing approval. Conducting the study under a protocol jointly agreed with both the FDA and EMA provides a well-defined regulatory pathway for future submissions in major global markets. The company believes Piclidenoson’s combination of oral administration, differentiated mechanism of action, and established safety profile positions it to address an important unmet need in the expanding global psoriasis therapeutics market. If the upcoming interim analysis produces positive efficacy and safety results, the program could strengthen Piclidenoson’s position as a potential long-term treatment alternative for patients seeking effective non-biologic therapies for moderate-to-severe plaque psoriasis.
Source:Can-Fite BioPharma press release
