Benzinga | Jul 15, 2020 07:02AM EDT

Can-Fite Completes Phase II COVID-19 Protocol Based on FDA Guidance, Says Plans to File IND Shortly

Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that it has amended its Phase II COVID-19 study protocol based on inputs from the U.S. Food and Drug Administration (FDA) and its Pre-Investigational New Drug (IND) fling. The Company plans to file an IND application with its completed protocol before the end of July.

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 all receive standard supportive care. Eligible patients are those diagnosed 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.

"We believe Piclidenoson is a promising candidate to treat COVID-19 because it combines both anti-viral and anti-rheumatic properties in one drug. Recent studies have shown anti-viral and anti-rheumatic drugs have improved outcomes for COVID-19 patients, leading to the U.S. FDA issuing emergency use authorization for the anti-viral drug remdesivir for the treatment of COVID-19, while some U.S. hospitals are treating COVID-19 patients with Actemra(r) (tocilizumab), a rheumatoid arthritis drug," stated Can-Fite CEO Dr. Pnina Fishman.

Piclidenoson, an A3 adenosine receptor (A3AR) agonist, has a well-established safety record in the U.S. and globally, and has been dosed in over 1,000 patients in clinical studies for the treatment of rheumatoid arthritis and psoriasis. The use of A3AR agonists as potent anti-inflammatory agents in addition to standard of care in acute infectious diseases where host defense responses are overwhelming, leading to cytokine storm and death, is supported by several peer reviewed studies, as well as by Can-Fite's own work in the field of adenosine biology. A3AR agonists are effective in models of inflammation and sepsis.