Piclidenoson (formerly known as CF101) is a first-line treatment for rheumatoid arthritis (RA) under development by Can-Fite Biopharma. It may well be a future option for the current first-line treatment, methotrexate.

The investigative therapy is a novel anti-inflammatory agent from the A3 adenosine receptor agonist (A3AR) class that works by inhibiting the production of inflammatory cytokines (molecules that help stimulate the movement of cells towards sites of inflammation or infection).

Almost half the people with RA who take methotrexate usually stop the treatment within five years due to the drug’s serious side effects. A smaller proportion, from 10 to 30 percent of patients, are intolerant to methotrexate. This means there is a need for a new, safe, and effective treatment option.

Piclidenoson research

The ACRobat Phase 3 trial (NCT02647762) has recently been approved by Israel’s Barzilai Medical Center’s Institutional Review Board. The trial will assess whether piclidenoson can relieve the signs and symptoms of RA compared to methotrexate.

The primary objective of the study is low disease activity after 12 weeks of treatment compared to methotrexate. Secondary objectives include changes in joints, the sedimentation rate of red blood cells, and inflammation markers from the beginning until 12 weeks of treatment.

Participants will take 1 or 2 mg of piclidenoson or a placebo twice daily, or methotrexate or placebo once a week.

The study will take 24 weeks so researchers can collect information on the long-term effectiveness and safety of the drug. It is expected to enroll 500 participants in Israel, Europe, and Canada and to be completed by the end of 2018.

Prior piclidenoson studies (NCT00280917 and NCT00556894) have shown that the drug is safe and that it has the potential to be as effective or even more effective than methotrexate in people with RA. The results of a Phase 2b clinical trial (NCT01034306) where piclidenoson was given as a stand-alone treatment indicated that the drug acted as a disease-modifying anti-inflammatory treatment in people with rheumatoid arthritis.

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