EPIRUS Biopharmaceuticals, Inc. Announces Positive Phase 1 Data for BOW-015
1/7/2013 9:28:50 AM
BOSTON--(BUSINESS WIRE)--EPIRUS Biopharmaceuticals, Inc. (“EPIRUS”), formerly known as fourteen22 Inc, announced that its lead 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 a 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.