Can-Fite BioPharma Ltd, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced the U.S. Food and Drug Administration (FDA) has issued a “safe to proceed” notice for Can-Fite’s Investigational New Drug (IND) application for a Phase II study of its lead drug candidate Piclidenoson in the treatment of COVID-19. The 40 patient, 28-day study is cleared to commence patient enrollment. Piclidenoson has been dosed in over 1,400 patients in prior trials as well as two ongoing Phase III studies for the treatment of rheumatoid arthritis and psoriasis.

“Having received this go-ahead from the FDA, and given the urgency of finding safe and effective treatments for COVID-19, we are eager to enroll and start treating patients,” stated Can-Fite CEO Dr. Pnina Fishman. “We believe Piclidenoson’s unique combination of anti-inflammatory effect and very favorable safety profile make it an ideal candidate to treat the complications of COVID-19.”

The Phase II study titled “Piclidenoson for Treatment of COVID-19 – A Randomized, Double Blind, Placebo-Controlled Trial” is a pilot trial in a population of hospitalized patients who will receive Piclidenoson in addition to standard supportive care. Eligible patients are those with “moderate” COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Forty patients will be randomly assigned in a 1:1 ratio to the trial arms of Piclidenoson 2 mg twice daily or placebo, and treated for up to 28 days. Efficacy will be assessed through standard measures of clinical and respiratory status at Day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen. Safety and pharmacokinetic data will also be captured.

About Piclidenoson

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. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases and for the treatment of COVID-19. It is being evaluated in multinational Phase III studies as a first line treatment to replace methotrexate in the treatment of rheumatoid arthritis, and as a treatment for moderate-to-severe psoriasis.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd.  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, inflammatory disease and COVID-19. The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and 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 successfully achieved its primary endpoint in a Phase II 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