Can-Fite moves towards opening Phase 3 study of adenosine A3 receptor agonist, CF101 in rheumatoid arthritis

• Can-Fite is developing A3 agonist, CF101 for rheumatoid arthritis and psoriasis. 
  
• A3 receptors are over-expressed in rheumatoid arthritis and this correlates with lower disease activity suggesting a possible compensatory mechanism
• Can-Fite reported positive top line data from a 12wk Phase 2b monotherapy study of CF101 (1mg bid) in Dec 2013 and then in more detail at ACR 2014
• Of particular interest, in patients with higher baseline A3 expression (greater than 1.5-fold higher than the mean; approx 70% of patients), ACR20 rates reached 50%, and 75% in patients naive to systemic therapy.  These data are particularly impressive given the clean safety profile
  
• Can-Fite has now announced that it has completed the design of its Phase 3, 300 patient study
• The study will evaluate 2mg or 3mg bid, higher doses than those studied in the Phase 2b trial
• A3 receptor expression will be determined prior to dosing and correlated with efficacy.  Of interest, Can-Fite is developing a commercial biomarker blood test kit for the A3 receptor
  

Comments:  Further details on the Phase 3 design are eagerly awaited.  In particular we hope that treatment naive patients will be included given the efficacy in these patients in the Phase 2b study and the potential for CF101, with its excellent safety profile, to occupy an early line treatment option, sparing steroids and avoiding MTX

Stop press:  Since this editorial was initially posted we have been in contact with Can-Fite sources and understand that patients will be both naive to prior treatment and experienced.  Concomitant MTX therapy will not be allowed in the study.  Finally, like the Phase 2b study inclusion will depend on baseline A3R expression

This alert is from our UpdatesPlus service. This service monitors and analyzes breaking journal articles, clinical trials and R&D news across the inflammatory disease spectrum - to access our most issue of UpdatesPlus-Rheumatoid Arthitis including a full development landscape and clinical  timeline please contact fiona.watts@leaddiscovery.co.uk