Cf101

Published

dm+d

Unassigned

New Medicines

Rheumatoid arthritis (RA)

Information

New molecular entity
Can-Fite BioPharma Ltd
Can-Fite BioPharma Ltd

Development and Regulatory status

None
Phase II Clinical Trials
Phase III Clinical Trials

Category

A3 adenosine receptor (A3AR) agonist
About 1 in 100 people develops RA at some stage in their life. RA develops at any age, but most commonly starts between the ages of 40 and 60. It is about three times more common in women than in men.
Rheumatoid arthritis (RA)
Oral

Trial or other data

01. CF101 is a small molecule orally bioavailable drug which binds with high affinity and selectivity to the A3AR, which is known to be over-expressed in inflammatory cells. The correlation between A3AR expression levels prior to treatment and patients´ response to CF101 suggests that the A3AR may be utilided a predictive biomarker to be analyzed prior to patients´ treatment. [1]
02. Dec 13: PIIb trial results (n=79 with active rheumatoid arthritis). Two arms: placebo or CF101 given orally BD for 12 weeks. CF101 1mg met all primary efficacy endpoints: ACR20 response rates: placebo 25%, CF101 45%, p=0.035; ACR50: placebo 9%, CF101 19% and ACR70: placebo 3%, CF101 11%. Response was cumulative over time, suggesting a consistent anti-inflammatory effect. CF101 was well tolerated with no evidence of immunosuppression. [1]
03. Jan 16: NCT02647762 is a PIII RCT due to start Jan 16 and to complete Dec 18. It will recruit 456 patients with RA and compare 1mg or 2mg CF101 to placebo over 16 weeks of treatment. The primary outcome is ACR20/ACR/EULAR-Good response [2]