EPIRUS’ BOW-015 achieves bioequivalence to Remicade in a single dose comparator trial

Published on January 3, 2013 at 12:59 AM · No Comments

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-∞), as well as the secondary objectives of safety, tolerability and immunogenicity.

"The data from this Phase 1 study are encouraging and support the bioequivalence of BOW-015 with Remicade.  Biosimilars, when developed with the proper rigor, will offer patients around the world similarly effective biological therapies that should be less costly than those currently available.  I look forward to seeing data from the ongoing Phase 3 trial," commented Jonathan Kay , MD, Professor of Medicine, University of Massachusetts Medical School, and Director of Clinical Research, Division of Rheumatology, UMass Memorial Medical Center, Worcester, Massachusetts.

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

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