Epirus: RA drug comparable to Remicade in phase 3 trial

Epirus Biopharmaceuticals Inc. has announced positive results from a phase 3 clinical trial that compared its infliximab molecule BOW-015 to infliximab in treating patients with severe rheumatoid arthritis.

In the treatment of patients with severe rheumatoid arthritis, BOW-015 achieved its primary objective of American College of Rheumatology 20% response (ACR20) at week 16 of 89.8% compared with 86.4% for infliximab (Remicade, Janssen Biotech Inc.), according to a press release. Prescribed statistical endpoint was met at a 95% confidence interval, Epirus reported, with no meaningful differences in safety or immunogenicity observed.

In the double-blind, active comparator study, 189 patients were randomly assigned to receive infusions of BOW-015 (3 mg/kg; n=127 patients) or infliximab (3mg/kg; n=62) using the approved Remicade dosing regimen. At week 22, responders were placed in a single BOW-015 open-label treatment arm. Those patients will be followed for a total of 54 weeks, Epirus reported.

Long-term efficacy, safety and tolerability of BOW-015 up to week 54, investigation of serum concentrations of BOW-015 and infliximab and associated immunogenic response were secondary endpoints, according to the release.

“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,” Jonathan Kay, MD, clinical adviser to Epirus and professor of medicine and director of clinical research at UMass Memorial Medical Center and the University of Massachusetts Medical School, said in the release.

Epirus plans to submit regulatory filings to targeted markets over the next 12 months, according to Amit Munshi, president and chief executive officer of the Boston-based biotechnology company.

Complete details of the study will be released at an upcoming major medical meeting, Epirus reported.