- Can-Fite BioPharma ( NYSE: CANF ) said it submitted a market registration plan to the European Medicines Agency (EMA) for Piclidenoson to treat moderate to severe psoriasis.
- The company added that a submission to the U.S. Food and Drug Administration (FDA) will follow.
- Registration plans for the EMA and FDA include efficacy and safety results from a phase 3 study called COMFORT and the protocol for an upcoming phase 3 pivotal trial together with a request for registration advice from the regulators.
- "Piclidenoson’s clinical trial results to date demonstrate its highly favorable safety profile which is similar to placebo, superior to oral Otezla, and based on published studies, far superior to biologics," said Can-Fite's Medical Director Michael Silverman.
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Can-Fite files market registration plan to EMA for psoriasis therapy