Epirus’ Phase 3 study data will be presented at ACR annual meeting

November 18, 2014 7:31 AM

Epirus Biopharmaceuticals, Inc. today announced they will present data at the 2014 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP), on November 18.

Dr. Jonathan Kay, Professor of Medicine, University of Massachusetts Medical School, Director of Clinical Research, Division of Rheumatology, University of Massachusetts Memorial Medical Center, is the lead author of their Phase 3 study, “BOW015, a biosimilar infliximab, in Patients with Active Rheumatoid Arthritis on Stable Methotrexate Doses: 54-Week Results of a Randomized, Double-Blind, Active Comparator Study.”

The poster includes positive 54-week follow up data from the BOW015 efficacy and safety trial comparing BOW015, a biosimilar infliximab, to Remicade. 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 BOW015 to Remicade for safety and efficacy and was followed by an open label phase in which Remicade responders were switched to BOW015. 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 BOW015,” said Dr. Kay. “I am pleased that the ACR selected this study for presentation as a late breaking abstract, since this study demonstrates the efficacy and safety of BOW015 to treat the many patients who suffer with rheumatoid arthritis and other inflammatory diseases.”

The poster, #L20, will be displayed from Sunday, November 16 to Tuesday November 18 and will be presented on Tuesday, November 18, from 9 am — 11 am EDT in Exhibit Hall B. The abstract is available online through the ACR website at www.rheumatology.org.

“We are pleased to share the latest data on our lead compound with the rheumatology community,” said Amit Munshi, president and CEO of Epirus. “This data demonstrates the long term durability of the response and safety of BOW015 therapy and represent another important step in making this drug available to patients globally.”

Source: Epirus Biopharmaceuticals

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