Benzinga | Jan 13, 2022 11:45AM EST

Can-Fite BioPharma Announces Pre-Clinical Studies Showing Piclidenoson 'Destroys Pathological Skin Cells in vitro'

Piclidenoson has been out-licensed for the indication of psoriasis in certain major markets

Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that pre-clinical studies with skin cells, modeling psoriasis in humans, show that Piclidenoson, the Company's drug candidate for the treatment of psoriasis, destroys pathological skin cells. The Company's scientists reported that in a cell culture of human HaCaT cells, incubated with Piclidenoson, cell apoptosis was induced with an increase in the caspase protein, known to mediate apoptotic responses.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies.

The Company expects to announce topline results during Q1 2022 from its randomized, double blind, active and placebo-controlled study currently being conducted in Europe, Israel, and Canada. The study's primary endpoint is the proportion of patients who achieve a PASI score response of ?75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Otezla(r) in weeks 16 and 32. Patients enrolled in the study have been selected based on their over-expression of A3AR, Can-Fite's therapeutic target.

"The data shown in our lab experiments are important and support the mechanism of action of Piclidenoson and supply additional support for the drug effect. We are encouraged by the positive interim analysis data reported last year based on 200 patients' data and hope that it will be reproducible and that psoriasis patients will benefit from safety and long term relief from the symptoms of psoriasis," stated Can-Fite CEO Dr. Pnina Fishman.

According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.