Novel Psoriasis Therapy to be Submitted to FDA

Can-Fite BioPharma has announced plans to submit applications to the FDA and the European Medicines Agency (EMA) for its lead drug candidate piclidenoson in the treatment of moderate-to-severe psoriasis. Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist small molecule that inhibits the inflammatory cytokines interleukin 17 and 23.

The company plans to submit the final efficacy and safety results from the phase 3 COMFORT study, which assessed the efficacy and safety of piclidenoson in more than 400 adults with moderate-to-severe plaque psoriasis. The study met its primary endpoint with statistically significant improvement over placebo in psoriasis patients.

Topline results released in June 2022 showed that at week 16, patients receiving piclidenoson 3 mg demonstrated statistically significant improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response 3mg: 9.7% vs. placebo: 2.6%.

Secondary endpoint parameters at week 32 comparing piclidenoson with the active control drug, Amgen’s Otezla (apremilast), revealed inferiority with respect to PASI 75, but revealed superiority of piclidenoson as compared with Otezla in the Psoriasis Disability Index (PDI) 20.5% vs. 10.3%, respectively.

Additional safety analysis of the COMFORT data points toward a better safety profile for piclidenoson compared with Otezla (apremilast), according to Can-Fite. Otezla induced gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or piclidenoson. Discontinuation of treatment among patients treated with Otezla was significantly higher compared with that of the piclidenoson treated patients.

The company indicated full results from the COMFORT study will be presented at an upcoming medical conference and published in a peer-reviewed medical journal.

Additionally, current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data will be submitted to the agencies along with a pivotal phase protocol and other supporting clinical pharmacology plans.