Can-Fite Receives Positive Response from FDA for Psoriasis Pediatric Plan

The manufacturer aims to provide a safe, effective treatment for psoriasis in children.

The U.S. Food and Drug Administration (FDA) gave a positive response to a study plan for piclidenoson in children suffering from psoriasis.

The plan allows for children to enroll in the phase 3 pivotal clinical study aiming at registering the drug with both the FDA as well as the European Medicines Agency (EMA) for the treatment of plaque psoriasis. Despite the availability of several small-molecule drugs available on the market for the treatment of psoriasis in children, according to the manufacturer, each of them have safety and efficacy issues, creating a high market need for a therapy with an adequate safety profile and reasonable efficacy in this young patient population. 

"We believe Piclidenoson’s oral formulation with its excellent safety profile, combined with its progressive effectiveness over time make it ideally suited for the chronic treatment of psoriasis in adults and children alike,” stated Can-Fite VP Drug Development, Dr. William Kerns, in a news release.

According to the manufacturer website, piclidenoson's safety profile has been demonstrated in preclinical studies, including toxicology studies of up to 6 months in mouse models and 9 months in monkey models. It's safety profile was also demonstrated in more than 1,200 patients. The manufacturer also highlighted a phase 2 study in psoriasis successfully met its primary endpoint showing that the drug effectively ameliorated disease symptoms. Phase 2/3b study data showed clinical activity from week 16 till 32, while the phase 3 study is ongoing. The manufacturer also notes a direct correlation between A3AR at baseline and patient response to piclidenoson, suggesting utilization as a predictive biomarker.