Date: 2014-09-23
Type of information: Results
phase: 3
Announcement: results
Company: Epirus Switzerland (Switzerland) EPIRUS Biopharmaceuticals (USA - MA)
Product: BOW015 (infliximab - biosimilar version of Remicade®)
Action mechanism:
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On May 9, 2016, Epirus Biopharmaceuticals announced reprioritization of the company's pipeline to focus exclusively on developing biosimilars for the treatment of rare diseases. This includes reallocating resources to focus on the development of BOW080 (eculizumab; reference biologic Soliris®) for the potential treatment of ultra-rare blood disorders and BOW070 (tocilizumab; reference biologic Actemra®) for the potential treatment of an uncommon lymphoproliferative disorder known as Castleman's disease. Epirus will suspend lead program BOW015 and work to further evaluate strategic options for the program, which may include partnerships, divestitures and/or other value-generating alternatives. The Company's decision to suspend its BOW015 program is based on cost-savings, not technical reasons, and the program remains ready to commence its planned global Phase 3 clinical study. * On September 23, 2014, EPIRUS Biopharmaceuticals, announced positive 58 week follow up data from its BOW015 efficacy and safety trial comparing BOW015, a biosimilar infliximab, to Remicade®. “The open label phase of the study was designed to provide data on long term safety and durability of response as well as long term safety for Remicade responders switching to BOW015. This data suggests the patients can safely be started and maintained on BOW015 and that patients can be safely switched from Remicade to BOW015,” said Michael Wyand, DVM, PhD, senior vice president of clinical, regulatory and manufacturing. 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. The full data will be presented at an upcoming medical meeting. The Phase 3 trial previously met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity. 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. * On June 11, 2014, Epirus Switzerland, 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). 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.
