Can-Fite BioPharma Ltd. announced that it received a positive response from the U.S. Food and Drug Administration (FDA) on the Pediatric Study Plan for the treatment of children suffering from psoriasis with Piclidenoson. The plan has been submitted to allow enrollment of children with psoriasis to Can-Fite?s upcoming Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis. There is a high market need for a safe and efficacious drug for the treatment of children who suffer from psoriasis.

There are a couple of small molecule or biological drugs on the market, however all have safety issues and are not satisfactory regarding efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease. Can-Fite believes the inclusion of children in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug.

Psoriasis affects millions of people worldwide, including a significant number of children who endure the physical and emotional burden of this challenging disease.