Epirus initiates pivotal global Phase 3 study for BOW015 (infliximab biosimilar)

February 12, 2016 8:29 AM

Epirus Biopharmaceuticals, Inc., announced the initiation of its global registration study for BOW015 (infliximab, reference biologic Remicade) in active Rheumatoid Arthritis (RA) patients.

Epirus plans to enroll over 500 patients in the UNIFORM Study, which will be conducted at sites in Europe, North America and Latin America.

The UNIFORM Study is a 58-week, double-blind, one-to-one randomized, comparator-controlled multi-center global study to compare efficacy, safety and immunogenicity and demonstrate clinical equivalence of BOW015 with Remicade. The primary endpoint at week 16 is the proportion of patients that meet ACR20 (20 percent or greater improvement in American College of Rheumatology assessment). Epirus is targeting a harmonized global filing for marketing approval for BOW015 in 2017 based on 30-week data.

“The initiation of the UNIFORM Study is a major milestone for the BOW015 biosimilar clinical program,” said Amit Munshi, president and chief executive officer, Epirus Biopharmaceuticals. “Following completion last quarter of manufacturing process lock, which we believe is an important risk-reducing milestone in our development program, our team continues to make progress toward market entry in the United States and Europe. This study, along with patient exposure and pharmacovigilance data from patients currently receiving treatment, is designed to provide the foundation for our global filing.”

The UNIFORM Study continues the global clinical development program, building on positive data from Epirus’ Phase 1 study in healthy volunteers and Phase 3 study in active RA patients presented at recent American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) meetings. The data presented reinforced the analytical, pharmacokinetic, safety and efficacy profile for BOW015, further demonstrating biosimilarity between BOW015 and infliximab. To date nearly 1,000 patients have already been treated with BOW015.

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