Can-Fite’s Phase III Psoriasis Study Data Expected Q2 2022

PETACH TIKVA, Israel--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that top line data from its Phase III Comfort™ study of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis are scheduled to be released in Q2 2022 due to an unanticipated delay in the collection of study data. The study enrolled more than 400 patients across 30 sites in Europe, Israel, and Canada.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a mechanism of action involving inhibition of 2 cytokines, interleukin-17 and interleukin-23, both pivotal for the formation of skin lesions. Piclidenoson has also recently shown to induce death of pathological skin cells.

The Comfort randomized, double blind, active and placebo-controlled study’s primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16, and secondary endpoints include non-inferiority to Otezla®, a leading oral drug on the market, at week 32. Piclidenoson is administered twice daily orally.

“While we had been expecting to announce topline results in the first quarter of 2022, it is taking longer than expected to gather and tabulate the data from this 400-plus person international study. We now expect to report results in the second quarter of 2022. We look forward to analyzing the data and are hopeful that Piclidenoson may prove to be an effective treatment with minimal to no side effects in the $11 billion psoriasis market,” stated Can-Fite CEO Dr. Pnina Fishman.

Otezla reported generating $2.2 billion in sales in 2020. 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.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson 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 and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

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