【Can-Fite BioPharma-Product CF101】Can-Fite to Submit FDA & EMA Registration Plans for Piclidenoson in the Oral Treatment of Moderate to Severe Psoriasis

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Further analysis of Phase III COMFORT data show Piclidenoson’s superior safety profile and higher patient compliancecompared to Otezla

11th July, 2022- Can-Fite BioPharma issued a press release, which is summarized as follows:

Can-Fite BioPharma is planning to submit its registration plans to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its lead drug candidate Piclidenoson in the treatment of moderate to severe psoriasis.

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. Further analysis of the Phase III COMFORT data point towards a better safety profile for Piclidenoson as compared to Otezla, which induced gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson. Discontinuation of treatment amongst patients treated with Otezla was significantly higher compared to that of the Piclidenoson treated patients.

A sub-analysis of the efficacy data that divided patients into those who had PASI>25 (more severe psoriasis) and PASI<25 (less severe) at baseline revealed that patients who started with higher PASI values at entry benefitted more from treatment with Piclidenoson as compared to placebo. This result demonstrates the efficacy of Piclidenoson in the treatment of patients with more severe disease.

In its registration plans, Can-Fite will submit the final efficacy and safety results from COMFORT, a multicenter, randomized, placebo- and active-controlled, double-blind study that assessed the efficacy and safety of Piclidenoson in more than 400 adults with moderate to severe plaque psoriasis together with a request for registration advice to the FDA and EMA. Additionally, current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data will be submitted to the agencies along with a pivotal Phase III protocol and other supporting clinical pharmacology plans.

“If Piclidenoson achieves its primary endpoint once again in an upcoming pivotal Phase III study, Piclidenoson will offer a safe and effective long-term treatment for people living with psoriasis, including those with the most severe cases,” stated Can-Fite Medical Director, Dr. Michael Silverman.

The original website link: https://ir.canfite.com/news-events/press-releases/detail/994/can-fite-to-submit-fda-ema-registration-plans-for