Can-Fite BioPharma has initiated a pivotal Phase 3 clinical trial for its oral psoriasis drug Piclidenoson, following protocol approval from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). The study will focus on patients with moderate to severe plaque psoriasis, with initial enrollment beginning in Europe before expanding to the United States and Canada.
The global psoriasis treatment market is projected to reach $30 billion by 2030, with a significant shift toward oral medications, positioning Piclidenoson as a potentially important addition to the treatment landscape.
Trial Design and Endpoints
The Phase 3 study employs a randomized, double-blind, placebo-controlled design to evaluate both safety and efficacy in moderate to severe plaque psoriasis patients. Participants will receive either 3 mg Piclidenoson tablets twice daily or a matching placebo.
The trial features two co-primary efficacy endpoints measured at Week 16:
- The proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75)
- The proportion of patients achieving a Static Physician's Global Assessment (sPGA) score of 0 or 1
Notably, the FDA has requested two Phase 3 safety and efficacy studies and encouraged the inclusion of adolescent patients, citing Piclidenoson's strong safety profile demonstrated throughout its development history and previous clinical studies.
"We are excited to initiate the Phase 3 study and we believe that Piclidenoson's oral dosage and excellent safety record, together with its progressive effectiveness over time, make it an ideal drug for the chronic treatment of psoriasis," stated Can-Fite CEO Motti Farbstein.
Mechanism of Action and Development Path
Piclidenoson represents a novel approach to psoriasis treatment as a first-in-class A3 adenosine receptor agonist (A3AR). The drug's mechanism of action involves inhibiting inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) while inducing apoptosis of keratinocytes involved in disease pathogenicity.
The compound has already demonstrated efficacy in both Phase 2 and earlier Phase 3 clinical studies, with an established safety profile across more than 1,600 patients in various clinical trials.
Upon successful completion of the Phase 3 program, Can-Fite plans to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA.
Psoriasis Treatment Landscape
Psoriasis affects millions worldwide, causing painful, scaly plaques on the skin that significantly impact quality of life. Current treatment options include topical therapies, phototherapy, and systemic medications, with biologics dominating the high-end market despite their injectable administration and high costs.
An effective oral medication with a favorable safety profile could address significant unmet needs in the psoriasis treatment paradigm, particularly for patients seeking alternatives to injectable biologics or those with moderate disease not severe enough to warrant biologic therapy.
Company Pipeline
Beyond Piclidenoson, Can-Fite is advancing several other candidates through clinical development:
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Namodenoson: Currently in Phase 3 trials for hepatocellular carcinoma (HCC), Phase 2b for metabolic dysfunction-associated steatohepatitis (MASH), and Phase 2a for pancreatic cancer. The drug has received Orphan Drug Designation in both the U.S. and Europe, along with Fast Track Designation for second-line HCC treatment from the FDA.
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CF602: Has demonstrated efficacy in erectile dysfunction treatment in preclinical studies.
The company's platform technology targets multi-billion-dollar markets across oncology, liver disease, and inflammatory conditions, with all candidates showing favorable safety profiles in clinical studies to date.
