Can-Fite Applies to Maintain RA Section 3 Trial for Piclidenoson in Canada
Can-Fite BioPharma has filed a scientific trial utility (CTA) with Well being Canada for piclidenoson (CF101) as a remedy for rheumatoid arthritis (RA).
Piclidenoson is an orally bioavailable drug with a positive therapeutic index that’s underneath growth for the remedy of autoimmune inflammatory illnesses like RA and psoriasis. It’s a brand new, first-in-class A3 adenosine receptor agonist (A3AR).
Can-Fite’s aim is for piclidenoson to switch the present commonplace of care, methotrexate (MTX), as a result of 10 to 30 p.c of sufferers are illiberal to MTX remedy.
“We sit up for a optimistic response from Well being Canada to our CTA in order that we could start enrolling sufferers in Canada for our upcoming Section 3 research. Having just lately obtained Institutional Assessment Board (IRB) approvals in Israel for our rheumatoid arthritis trial, we’re able to increase into scientific websites in Canada and Europe,” Can-Fite CEO Pnina Fishman mentioned in a information launch.
The corporate hopes to start out its Section 3 Acrobat trial (NCT02647762) evaluating the effectiveness of piclidenoson in RA sufferers in a number of months.
“New therapies are wanted for individuals who face the tremendously debilitating signs of rheumatoid arthritis,” mentioned Robert Tessarolo, president and CEO of Cipher Prescription drugs, Can-Fite’s Canadian distribution companion. “We’re wanting ahead to a optimistic final result from the piclidenoson Section 3 scientific program to assist handle this persistent illness.”
The randomized, placebo-controlled Section 3 trial will take a look at the speculation that sufferers with RA receiving piclidenoson will expertise reduction within the indicators and signs of the illness.
Sufferers can be randomized to considered one of 4 remedy teams: piclidenoson at 1 mg; piclidenoson at 2 mg; MTX; or matching placebo tablets. Piclidenoson or a placebo can be administered each 12 hours for as much as 24 weeks. MTX or an identical placebo can be administered as soon as per week.
The research’s major endpoint is attaining low illness exercise after 12 weeks of remedy, evaluating the outcomes with these of MTX and placebo controls. Secondary endpoints embrace the change from baseline in swollen joint depend, tender joint depend at every go to after 12 weeks of remedy, in addition to different efficacy and security parameters. Roughly 525 RA sufferers are anticipated to be enrolled in Canada, Israel, the U.S., and Europe.
