Baricitinib: Phase III started
Incyte disclosed in its 3Q12 earnings that Eli Lilly began the double-blind, placebo-controlled, international Phase III RA-BEAM trial to compare 4 mg oral baricitinib once daily for 52 weeks vs. 40 mg subcutaneous adalimumab every 2 weeks in about 1,280 patients with moderately or severely active RA who have are resistant to methotrexate. Patients will continue to receive background methotrexate therapy.
The start of Phase III testing triggered a received $50 million milestone payment to Incyte from Eli Lilly under a December 2009 deal granting the pharma exclusive, worldwide rights to develop and commercialize baricitinib for RA. The Phase III program comprises 4 trials - RA-BEGIN, RA-BEAM, RA-BUILD and RA-BEACON - and the RA-BEYOND extension trial. In 2010, Incyte exercised its option to co-develop baricitinib to treat RA under the 2009 deal (see BioCentury, Jan. 4, 2010 & Aug. 16, 2010). ...