Can Fite BioPharma Ltd (CANF)

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FDA Clears Can-Fite to Commence Phase II COVID-19 Study

Business Wire Business Wire•August 31, 2020

FDA Clears Can-Fite to Commence Phase II COVID-19 Study
Piclidenoson has a robust anti-inflammatory effect with an excellent safety profile

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 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.

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