Can-Fite BioPharma Ltd. announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - approved clinical study protocol. The study will enroll patients with moderate to severe plaque psoriasis. Patients will be treated with 3 mg twice daily orally Piclidenoson tablets or placebo.

The co-primary efficacy objectives of this study are the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of 75% (PASI 75) and the proportion of subjects who achieve an Static Physician's Global Assessment (sPGA) at of 0 or 1 at Week 16. 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. 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.

Piclidenoson is a novel, robust anti-inflammatory first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. The drug's mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients' skin cell keratinocytes involved with the disease pathogenicity. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer.amodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food & Drug Administration.

Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma.