Can-Fite BioPharma Ltd. 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 First Quarter 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 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.