CF101: Phase IIb data
Top-line data from a double-blind, international Phase IIb trial in 79 active RA patients with elevated baseline expression levels of ADORA3 in peripheral blood mononuclear cells (PBMCs) showed that twice-daily 1 mg oral CF101 met the primary endpoint of improving ACR20 response rate at week 12 vs. placebo (49% vs. 25%, p=0.035). On secondary endpoints, the ACR50 response rate at week 12 was 19% for CF101 vs. 9% for placebo and the ACR70 response rate at week 12 was 11% for CF101 vs. 3% for placebo. Can-Fite said the study was not designed to test for significance on the ACR50 and ACR70 endpoints. CF101 was well tolerated with no evidence of immunosuppression reported. Data will be presented at the Autoimmunity meeting in Nice in March. Can-Fite, which made the announcement on Dec. 23, 2013, said it is too early to determine a time frame for when Phase III trials with CF101 to treat RA are slated to start. ...