Market registration plans submitted to EMA for CF 101 in psoriasis
Can-Fite BioPharma announced it has submitted a market registration plan to the European Medicines Agency (EMA) for its lead drug candidate CF 101 (piclidenoson) in the treatment of moderate to severe psoriasis. A submission to the FDA will follow
Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s successful COMFORT Phase III study and the protocol for the Company’s upcoming Phase III 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 III COMFORT study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for piclidenoson. The Phase III COMFORT data point towards a better safety profile for piclidenoson as compared to Otezla, the leading oral therapy for psoriasis on the market today, 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.
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