Can-Fite BioPharma has submitted to the European Medicines Agency (EMA) a protocol design for its Phase III trial and Registration Plan for the Company's lead compound CF101 in the treatment of rheumatoid arthritis following a pre-submission meeting with the EMA.
The global trial is expected to commence in either the second or third quarter of 2016.
The planned Phase III trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional disease modifying drugs.
The study will have three arms, a 1 mg CF101 dose, a 2 mg CF101 dose and placebo, given orally twice daily in the form of tablets. The study is expected to enroll 360 patients and the primary endpoint is expected to be low disease activity.
Inclusion criteria will include patients who have high expression of the A3 adenosine receptor (A3AR), a biomarker that has been shown by the company to identify patients who will respond to CF101. A3AR and its correlation to patients' response to the drug will be analyzed upon study conclusion.
Based on Can-Fite's Phase II clinical studies with CF101 in patients with active rheumatoid arthritis, the percentage of patients with high expression of A3AR is estimated to be approximately 70%.
"Submission of this Phase III protocol design to the EMA in the first quarter of 2016 was an important milestone and we look forward to commencing our trial, upon the European regulator's approval of our protocol. We plan to conduct the study in several European countries, Canada, U.S. and Israel. We were very pleased to be in a position to submit our Registration Plan for CF101, to the EMA, which we believe will give us greater visibility on our path to approval," stated Can-Fite CEO Dr. Pnina Fishman.
Rheumatoid arthritis is a chronic, systematic, autoimmune inflammatory disease that manifests as joint pain, stiffness, and swelling. According to Visiongain, the global rheumatoid arthritis market is forecasted to reach $38.5 billion by 2017.
About CF101
CF101 is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. CF101 is currently under development for the treatment of autoimmune inflammatory diseases including rheumatoid arthritis (completed Phase II) and psoriasis (completed Phase II/III).
