Can-Fite Enrolls First Patient in Phase II COVID-19 Study Under FDA Protocol

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced it has enrolled the first of 40 patients in its Phase II COVID-19 study.

The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Patients are randomized in a 1:1 ratio to receive 2 mg Piclidenoson 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.

Piclidenoson’s robust anti-inflammatory effect has the potential to treat COVID-19 and its mutations because it treats disease manifestations. The drug has anti-inflammatory effects proven in Phase II psoriasis clinical studies and in an interim analysis of an ongoing Phase III psoriasis study. The drug’s anti-viral properties are protected by U.S. patent US7589075. Piclidenoson also inhibits cytokine release syndrome which is associated with the severity of COVID-19.

“We are eager to test the potential benefits of Piclidenoson added to the current standard of care for patients hospitalized with moderate to severe COVID-19. The treatment modalities for COVID-19 continue to evolve as the medical community learns more about the disease. Piclidenoson’s proven anti-inflammatory effects combined with its excellent safety profile may improve outcomes and we look forward to seeing its impact following 28 days of treatment,” stated Can-Fite CEO Dr. Pnina Fishman.