Biotechnology company Can-Fite BioPharma has obtained approval from the Institutional Review Board (IRB) of Barzilai Medical Center in Israel, to begin patient enrolment in the Phase III ACRobat clinical trial of piclidenoson for the treatment of rheumatoid arthritis.
Can-Fite also expects to receive IRB approvals from medical centres in Canada and Europe.
Piclidenoson is an orally bioavailable, small molecule agonist of A3 adenosine receptor (A3AR) being developed as a first-line replacement therapy for the existing standard-of-care drug methotrexate (MTX).
Expected to enrol a total of up to 500 patients in Israel, Europe and Canada, the randomised, double-blind, active and placebo-controlled Phase III trial will evaluate 1mg and 2mg of piclidenoson twice-daily over a period of 24 weeks.
The trial will also include a once-weekly administration of MTX.
The primary endpoint of the trial is low disease activity following 12 weeks of treatment in comparison to MTX.
Can-Fite chief executive officer Dr Pnina Fishman said: "Piclidenoson has demonstrated its safety profile in over 1,000 patients and prior clinical data show its potential to be as effective, or more effective, than MTX in treating rheumatoid arthritis.
"Our ACRobat trial is powered to demonstrate piclidenoson's potential as a first line therapy and superior alternative to MTX, which unfortunately can have severe side effects for patients who need a long-term treatment solution."
Piclidenoson is also being evaluated in another Phase III clinical trial for the treatment of psoriasis and is reported to have shown favourable therapeutic index in Phase II trials.