Can-Fite BioPharma announced it has submitted a market registration plan to the European Medicines Agency (EMA) for its lead drug candidate Piclidenoson in the treatment of moderate to severe psoriasis. The company said a submission to the FDA will follow.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a safety profile demonstrating evidence of efficacy in Phase 2 clinical studies. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.

Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s COMFORT Phase 3 study and the protocol for the company’s upcoming Phase 3 pivotal trial together with a request for registration advice from the regulators. Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are also included.

Can-Fite recently reported topline results from its Phase 3 COMFORT study, which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson, according to a Can-Fite news release.

According to Can-Fite, the COMFORT data point toward a better safety profile for Piclidenoson as compared to Otezla, the leading oral therapy for psoriasis on the market, as Otezla induced: 1) gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson; and 2) 9.9% nervous system disorders in the Otezla vs. 0.7% in the Piclidenoson treated patients.

“Piclidenoson’s clinical trial results to date demonstrate its highly favorable safety profile which is similar to placebo, superior to oral Otezla, and based on published studies, far superior to biologics," Can-Fite’s Medical Director Michael Silverman, MD, said in a company news release. "Efficacy results from the COMFORT study show Piclidenoson is most effective longer term and with the most severe cases, suggesting it can be a preferred choice for the safe and effective treatment of this chronic condition."