EPIRUS Biopharmaceuticals, Inc. announced that its asset, BOW-015, achieved bioequivalence to Remicade® in a single dose comparator trial. In February 2012, the United Kingdom's MHRA (Medicines and Healthcare Regulatory Agency) approved the single center, double blind, randomized parallel group trial in 84 healthy male volunteers each of whom received a 5 mg/kg single infusion of BOW-015 or Remicade®. At the conclusion of the trial, BOW-015 met both the primary objectives of bioequivalence in Cmax, AUC(0-t) and AUC(0-8), as well as the secondary objectives of safety, tolerability and immunogenicity.

EPIRUS is currently conducting a registrational Phase 3 program for BOW-015 with initial data expected late 2013.