Epirus Biopharmaceuticals, Inc., 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 I 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 III trial,” commented Jonathan Kay, MD, Professor of Medicine, University of assachusetts Medical School, and Director of Clinical Research, Division of Rheumatology, UMass Memorial Medical Center, Worcester, Massachusetts.
Epirus is currently conducting a registrational Phase III program for BOW-015 with initial data expected in late 2013.
Epirus was financed in early 2011 by 5AM Ventures, Montreux Equity Partners and TPG Biotech. Following a restructuring in 2012, Epirus has expanded its focus to centrally develop a broad pipeline of biosimilar monoclonal antibodies, optimised for use within its SCALE™ disposable manufacturing system, and designed to be deployed in an “In Market, For Market”™ manufacturing configuration. This innovative platform is designed to enable localized manufacturing in key emerging economies where Epirus is developing partnerships combining public and private sector financial support and expertise.
Source: Epirus press release