Can-Fite BioPharma’s Phase 3 ACRobat clinical trial protocol was approved by Barzilai Medical Center’s Institutional Review Board (IRB) and patient enrollment is now ready to begin. The study will be evaluating piclidenoson (CF101) as a treatment for rheumatoid arthritis (RA) at the hospital in Ashkelon, Israel.
As enrollment begins in Israel, further IRB approvals in Europe and Canada are expected to follow.
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR). It is an orally bioavailable drug with a favorable therapeutic index. The candidate is currently being developed for the treatment of autoimmune inflammatory diseases like RA and psoriasis, hoping to replace the current standard of care, methotrexate (MTX).
The Arthritis Foundation of America reports that MTX is the most broadly used drug for the treatment of RA, but about 73 percent of patients who used the medication experienced at least one side effect.
Because about 10 to 30 percent of patients are intolerant to MTX treatment, Can-Fite reports there is an urgent need in the market for a new, safer, effective alternative treatment option.
Piclidenoson is headed into Phase 3 trials for RA and psoriasis. Achieving low disease activity after 12 weeks of treatment is the study’s primary endpoint, comparing the results with those of the MTX placebo controls.
The drug candidate will be given at 1 mg or 2 mg, twice daily. MTX or a placebo will be administered once weekly in a control group. The total duration of the trial will be 24 weeks to provide additional data on long-term effectiveness and safety.
Around 500 patients are expected to enroll at several trial sites in Israel, certain European countries, and Canada. For more information about the trial, please contact Motti Farbstein from Can-Fite at [email protected] (email) or by phone at +972-3-9241114.
“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,” Pnina Fishman, Can-Fite’s CEO, said in a press release.
“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,” Fishman added.
Can-Fite was responsible for designing the trial.
On May 24, the company will conduct an Investigator Meeting in Europe, where about 100 doctors involved in the study as clinical investigators will be invited to take part in a series of sessions about piclidenoson and the ACRobat protocol.