Phase III study of BOW 015 meets primary endpoint in Rheumatoid Arthritis-Epirus Pharma

Epirus Pharma has announced data from their Phase III study of BOW 015 (infliximab-biosimilar), in patients with active Rheumatoid Arthritis who are on stable Methotrexate doses: "54-Week Results of a Randomized, Double-Blind, Active Comparator Study,�. The study met its primary endpoint of ACR20 response, the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating 20% improvement in a group of clinical parameters. The first segment of the study was a 16-week, double-blinded, head-to-head comparison of BOW 015 to Remicade for safety and efficacy and was followed by an open label phase in which Remicade responders were switched to BOW 015. All patients were then followed for the duration of the 58 week study. The results of this study suggest that patients can be safely switched from Remicade to BOW 015. Data will be presented at the 2014 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals.