Can-Fite BioPharma has filed a clinical trial application (CTA) with Health Canada for piclidenoson (CF101) as a treatment for rheumatoid arthritis (RA).
Piclidenoson is an orally bioavailable drug with a favorable therapeutic index that is under development for the treatment of autoimmune inflammatory diseases like RA and psoriasis. It’s a new, first-in-class A3 adenosine receptor agonist (A3AR).
Can-Fite’s goal is for piclidenoson to replace the current standard of care, methotrexate (MTX), because 10 to 30 percent of patients are intolerant to MTX treatment.
“We look forward to a positive response from Health Canada to our CTA so that we may begin enrolling patients in Canada for our upcoming Phase 3 study. Having recently received Institutional Review Board (IRB) approvals in Israel for our rheumatoid arthritis trial, we are ready to expand into clinical sites in Canada and Europe,” Can-Fite CEO Pnina Fishman said in a news release.
The company hopes to start its Phase 3 Acrobat trial (NCT02647762) evaluating the effectiveness of piclidenoson in RA patients in a few months.
“New therapies are needed for people who face the tremendously debilitating symptoms of rheumatoid arthritis,” said Robert Tessarolo, president and CEO of Cipher Pharmaceuticals, Can-Fite’s Canadian distribution partner. “We are looking forward to a positive outcome from the piclidenoson Phase 3 clinical program to help manage this chronic disease.”
The randomized, placebo-controlled Phase 3 trial will test the hypothesis that patients with RA receiving piclidenoson will experience relief in the signs and symptoms of the disease.
Patients will be randomized to one of four treatment groups: piclidenoson at 1 mg; piclidenoson at 2 mg; MTX; or matching placebo tablets. Piclidenoson or a placebo will be administered every 12 hours for up to 24 weeks. MTX or a matching placebo will be administered once a week.
The study’s primary endpoint is achieving low disease activity after 12 weeks of treatment, comparing the results with those of MTX and placebo controls. Secondary endpoints include the change from baseline in swollen joint count, tender joint count at each visit after 12 weeks of treatment, as well as other efficacy and safety parameters. Approximately 525 RA patients are expected to be enrolled in Canada, Israel, the U.S., and Europe.