Epirus Biopharmaceuticals, Inc., a biotechnology company focused on the development and production of biosimilar products for major emerging markets, last week announced positive Phase 3 data from a clinical trial comparing the EPIRUS infliximab molecule BOW-015 to Remicade for the treatment of rheumatoid arthritis (RA).
The study in severe RA patients was designed as an equivalence trial comparing BOW-015 to Remicade. BOW-015 achieved a week 16 ACR20 response rate of 89.8%, compared to 86.4% for Remicade. This outcome met its prespecified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters.
No meaningful differences were observed in safety or immunogenicity. Complete details of the study, including secondary endpoints and full safety and immunogenicity data, will be released at an upcoming major medical meeting.
“Our mission at Epirus is to improve access to safe and effective biologic therapeutics for patients in emerging markets,” said Amit Munshi, the Company’s President and Chief Executive Officer. “The Phase 3 data announced today is an important milestones for us and underscores the technical competency of the Epirus team. We plan to submit regulatory filings in targeted emerging markets over the next 12 months.”
“The data supporting BOW-015’s clinical comparability to Remicade, combined with the focus of Epirus on emerging markets, will help expand patient access to this important medicine,” added Jonathan Kay, MD, 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. Dr. Kay serves as a clinical advisor to Epirus.
Editor’s note: Early this year, the company had announced the positive Phase I data results and expected the Phase 3 late 2013. This news means that, they are a bit ahead of the schedule.
Source: Epirus press release