An interim analysis is being implemented, and will be managed and monitored by an independent data monitoring committee 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 of Low Disease Activity at 12 weeks, and efficacy assessments will continue through 24 weeks of treatment.
Piclidenoson has been out-licensed for the indication of RA in Canada, South Korea, Spain, Austria, Switzerland, Hong Kong, Macau, Taiwan, and China. According to Visiongain, the RA therapeutic market is estimated to reach USD47 bn in 2024.
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies.
Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases.
It is being evaluated in a Phase III study as a first line treatment, to replace methotrexate, in the treatment of rheumatoid arthritis and a Phase III study in the treatment of moderate-to-severe psoriasis.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.
The company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma, the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis.
Namodenoson has been granted Orphan Drug Designation in the US and Europe and Fast Track Designation as a second line treatment for HCC by the US Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma.
CF602, the company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies and the company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction.
These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date.
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