Can-Fite submits pediatric plan to FDA for Piclidenoson in psoriasis treatment

Biotech leader Can-Fite BioPharma, known for its advances in oncology, inflammatory, and liver diseases, has taken a significant step forward with its announcement today of the submission of a pediatric study plan to the U.S. Food and Drug Administration (FDA). This ambitious move is for the treatment of adolescents with psoriasis using their proprietary drug candidate, Piclidenoson. The plan’s submission paves the way for the inclusion of adolescents in Can-Fite BioPharma’s imminent two Phase 3 pivotal clinical studies for psoriasis. The ultimate goal: register Piclidenoson for plaque psoriasis treatment with both the FDA and the European Medicines Agency (EMA).

Current treatments for adolescents suffering from psoriasis are few and far between. The market’s limited offerings—small molecule or biological drugs—often come with notable safety concerns and lack the desired efficacy. Recognizing this glaring market gap, Can-Fite BioPharma positions Piclidenoson as the answer—citing its commendable safety profile and high efficacy—as a transformative treatment for this debilitating chronic ailment.

This strategic inclusion of adolescents in the Phase 3 studies could expand the potential market reach of Piclidenoson significantly. The impact of psoriasis is felt globally, afflicting millions, including a vast adolescent population. This demographic grapples not just with the physical repercussions but also the psychological distress associated with this daunting disease.

Motti Farbstein, the CEO & CFO of Can-Fite BioPharma, voiced the company’s optimism. He emphasized, “Following the FDA’s counsel to integrate adolescents into our upcoming Phase 3 psoriasis trials, we’re confident in Piclidenoson. Its oral formulation, paired with an impressive safety track record and increasing efficacy over prolonged use, positions it as a promising chronic psoriasis treatment for both adults and the younger generation.”