Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has submitted to the European Medicines Agency (EMA) a protocol design for a Phase 3 trial and registration plan for its lead compound, CF101, in the treatment of rheumatoid arthritis. The company previously had a pre-submission meeting with the EMA.
The global trial is expected to begin in either the second or third quarter of 2016. It 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 is expected to enroll 360 patients in several European countries, Canada, U.S. and Israel. 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. Based on Can-Fite’s Phase 2 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%.
“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,” CEO, Dr. Pnina Fishman, said in a statement.