Can Fite BioPharma Ltd (CANF)

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Can-Fite Submitted to FDA a Pediatric Plan to Allow Registration of Piclidenoson for the Treatment of Adolescents with Psoriasis

https://finance.yahoo.com/news/fite-submitted-fda-pediatric-plan-110000850.html

FDA encouraged the Company to enroll adolescent patients due to Piclidenoson’s good safety profile

There is an unmet need for safe, convenient, and effective drugs to treat chronic plaque psoriasis in the adolescents

PETACH TIKVA, Israel, August 18, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory, and liver diseases, today announced that it submitted a pediatric study plan to the U.S. Food and Drug Administration (FDA) for the treatment of adolescents suffering from psoriasis with Piclidenoson.

The plan has been submitted to allow enrollment of adolescents with psoriasis to Can-Fite’s upcoming two 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 adolescents who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market in use for adolescents with psoriasis, all have safety issues and are not satisfactory regarding the 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 adolescent patients 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 adolescents who endure the physical and emotional burden of this challenging disease.

"Based on the FDA’s recommendation to enroll adolescents into the upcoming Phase 3 psoriasis trials, we believe Piclidenoson’s oral formulation with an excellent safety record, combined with its progressive effectiveness over time, make it ideally suited for the chronic treatment of psoriasis in adults and adolescents alike," stated Can-Fite CEO & CFO Motti Farbstein.