【Can-Fite BioPharma-Product CF101】Can-Fite BioPharma Completes 50% Patient Enrollment in its Phase III Psoriasis Trial

Partner News

09th Dec,2019 — Can-Fite BioPharma Ltd. issued an announcement, which is summarized as follows:

– Psoriasis therapeutic market estimated to reach $11.4B in 2020

– Distribution deals for the psoriasis indication are in place for Canada, China, Korea and European countries

Can-Fite BioPharma Ltd. announced today it has completed enrollment of over 50% of the 407 patients planned for its Phase III Comfort? trial to evaluate its drug candidate Piclidenoson in the treatment of moderate-to-severe plaque psoriasis.

The Comfort? Phase III psoriasis study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla®) in patients with moderate to severe plaque psoriasis.

The randomized, double blind study is being conducted in Europe, Israel, and Canada. The study’s primary end point is the proportion of subjects who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16. The secondary endpoints include non-inferiority to Otezla® on weeks 16 and 32.

“With just over half the patients enrolled in this pivotal Phase III study, we have achieved an important milestone. We look forward to completing enrollment and announcing topline results. We believe Piclidenoson is a potentially efficacious drug that can be safely used long-term on a daily basis by patients for chronic conditions,” stated Can-Fite CEO Dr. Pnina Fishman.

Piclidenoson has been out-licensed for the indication of psoriasis in Canada, South Korea, Spain, Austria, Switzerland, Hong Kong, Macau, Taiwan, and China. According to Visiongain, the psoriasis therapeutic market is estimated to reach $11.4B in 2020.

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