Epirus Biopharma Reports Positive 58 Week Follow Up Data For BOW015

(RTTNews) - Epirus Biopharmaceuticals Inc. (EPRS) announced positive 58 week follow up data from its BOW015 efficacy and safety trial comparing BOW015, a biosimilar infliximab, to Remicade. The data suggested that the patients can safely be started and maintained on BOW015 and that patients can be safely switched from Remicade to BOW015.

The overall study was comprised of a 16 week, double blinded, head to head comparison with Remicade for safety and efficacy followed by an open label phase where Remicade responders were switched to BOW015 and all patients were followed for the duration of the 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 a 20% improvement across a series of diagnostic parameters.

In the open-label phase, patients who continued on BOW015 were compared to patients who received four doses of Remicade, followed by a switch to four doses of BOW015. Immune responses as well as overall safety and tolerability for BOW015 were comparable to the arm switched from Remicade to BOW015 and were consistent with the expected profile of Remicade.

Further, ACR20 responses were durably maintained to 58 weeks from the week 16 primary endpoint previously reported.

Epirus is actively progressing applications for marketing approval for BOW015 in targeted global markets. In September 2014, EPIRUS announced final approval of BOW015 in India, the first infliximab biosimilar approved in India. Epirus also plans to initiate an additional Phase 3 trial in Europe in early 2015.