Phase 3 data demonstrate comparability of Epirus’ BOW015 to Remicade for rheumatoid arthritis

June 12, 2014 9:04 AM

Epirus Switzerland GmbH, a subsidiary of Boston-based Epirus Biopharmaceuticals focused on the global development and commercialization of biosimilar monoclonal antibodies, announced clinical data from a Phase 3 study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis (RA). 

Jonathan Kay, MD and Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School, presented the results of this trial at the European League Against Rheumatism (EULAR) Annual Conference.

This study in severe RA patients was designed as an equivalence trial comparing BOW015 to Remicade. BOW015 achieved a week sixteen ACR20 response rate of 89.8%, compared to 86.4% for Remicade, an outcome which met its pre-specified statistical endpoint. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with RA, indicating a 20% improvement across a series of diagnostic parameters.

The study also included ACR20 comparisons at two, six, and fourteen weeks.  No other clinical trial of a biosimilar infliximab has demonstrated and reported response to treatment at these earlier time points in advance of the sixteen week plateau phase.

Key secondary objectives of the study were to assess long-term efficacy, safety, tolerability, and immunogenicity.  No meaningful differences were observed between BOW015 and Remicade.  Results of the open label phase, including one year immunogenicity, one year safety, and long-term responder rates, are expected to be available in the third quarter of 2014.

“I am pleased to present data from the first study to compare early time points of the dose response curve of a biosimilar to its reference product,” said Jonathan Kay MD, “Data from early time points, prior to the plateau phase, allow for a more sensitive comparison of potency to demonstrate clinical equivalence.”

 

Source: EPIRUS press release

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