Can-Fite announced that it received a positive opinion from the Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency (EMA) with respect to the submission of a registration plan for a pivotal Phase III clinical trial for the treatment of moderate to severe psoriasis. The pivotal Phase III study and the safety of the 3 mg twice daily dose of Piclidenoson are accepted by the agency.
The Company intends to initiate a prospective double-blind, placebo-controlled and randomized clinical trial with its lead product Piclidenoson aimed at demonstrating clinical safety and efficacy for the treatment of moderate to severe psoriasis sufficient to support a marketing authorization application.
The agency also commented on the registration plan submitted by the Company relating to the chemistry, manufacturing, and controls (CMC), nonclinical data, and clinical pharmacology data. Can-Fite is currently submitting a comparable data package to the US Food and Drug Administration.
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.
“Piclidenoson’s oral dosage and excellent safety record combined with its progressive effectiveness over time make it ideally suited for the treatment of psoriasis, a chronic disease. Should this market registration study produce positive results similar to our COMFORT study, we believe Piclidenoson will be well positioned in a very large market which needs more safe and effective oral drug options,” stated Can-Fite CEO Dr. Pnina Fishman.
Original website link: https://ir.canfite.com/news-events/press-releases/detail/1014/can-fite-ema-gives-green-light-for-piclidenoson-pivotal