Can Fite BioPharma Ltd (CANF)

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Can-Fite Receives U.S. FDA’s Go Ahead for Piclidenoson Psoriasis Registration Plan

FDA encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies

https://www.businesswire.com/news/home/20230629172102/en/Can-Fite-Receives-U.S.-FDA%E2%80%99s-Go-Ahead-for-Piclidenoson-Psoriasis-Registration-Plan/

June 29, 2023 07:00 AM Eastern Daylight Time

PETACH TIKVA, Israel--(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 received feedback and advice from the U.S. Food and Drug Administration (FDA) with respect to non-clinical and clinical development and registration plans for Piclidenoson for the treatment of patients with moderate to severe plaque psoriasis.
The FDA had a positive view of the non-clinical studies conducted by the Company and the accumulated safety data that the Company submitted to the agency as part of the registration plan.

The FDA provided advice on the randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol with Piclidenoson that is aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. The FDA requested two Phase 3 safety and efficacy studies and also encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies. To harmonize the requests of the European Medicines Agency (EMA) and the FDA, Can-Fite plans to conduct two Phase 3 studies in parallel, including adolescent patients.

Can-Fite believes the inclusion of adolescent patients in one or both of the Phase 3 studies significantly broadens the 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. There are limited treatment options available for adolescent patients in the U.S. Otezla is not approved for use in adolescents, and existing oral options include steroids and off-label use of retinoids (acitretin) and methotrexate, both of which carry significant safety and tolerability issues for teenagers. The Company believes that Piclidenoson represents a promising oral option for this underserved population.

Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA.

“We are delighted to share the positive feedback that we received from the U.S. FDA and we believe that Piclidenoson’s oral dosage and excellent safety record, combined with its progressive effectiveness over time, make it ideally suited for the chronic treatment of psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.