03rd Feb，2020– Can-Fite BioPharma Ltd. issued an announcement, which is summarized as follows:
– Interim analysis by IDMC intended to improve study’s efficiency and accelerate path towards regulatory approval
– Piclidenoson evaluated as first line therapy and replacement for the current standard of care, methotrexate, the most widely used drug for rheumatoid arthritis
– Rheumatoid arthritis is forecast to be $47 billion market in 2024
Can-Fite announced today it has completed enrollment of approximately 50% of the 525 patients planned for its Phase III ACRobat? trial to evaluate its drug candidate Piclidenoson as a first-line treatment for rheumatoid arthritis (RA).
An interim analysis is being implemented, and will be managed and monitored by an independent data monitoring committee (IDMC) that will have un-blinded access to the data. Piclidenoson continues to be well tolerated, with approximately 50% of patients enrolled to date and treatment durations up to 24 weeks, and no novel or cumulative safety concerns have emerged.
The Phase III ACRobat? RA study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to methotrexate in patients with RA. An estimated 90% of RA patients receive methotrexate at some point in their disease. However, studies show that up to 50% of patients stop taking methotrexate due to reasons including drug intolerance, minor and major side effects, and lack of efficacy, creating a significant need for a new, safe and effective treatment option in the RA treatment market.
The randomized, double-blind, active- and placebo-controlled, Phase III study is enrolling patients with clinically active RA who have not been treated with methotrexate. In total, 525 patients will be randomly assigned to one of four groups in a 2:2:2:1 ratio: Piclidenoson 1 mg, Piclidenoson 2 mg, methotrexate, or placebo. The primary efficacy outcome measure is the proportion of patients achieving a Disease Activity Score (DAS) of Low Disease Activity (LDA) at 12 weeks, and efficacy assessments will continue through 24 weeks of treatment.
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