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Comparability to Remicade as measured by ACR20 response in severe rheumatoid arthritis (RA) patients
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No meaningful differences observed in safety or immunogenicity
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First market authorization filing in Q4 2013
BOSTON, MA, USA I August 28, 2013 I EPIRUS Biopharmaceuticals, Inc. (EPIRUS), a privately held biotechnology company focused on the development and production of biosimilar products for major emerging markets, today announced positive Phase 3 data from a clinical trial comparing the EPIRUS infliximab molecule BOW-015 to Remicade for the treatment of rheumatoid arthritis (RA).
This study in severe RA patients was designed as an equivalence trial comparing BOW-015 to Remicade. BOW-015 achieved a week 16 ACR20 response rate of 89.8%, compared to 86.4% for Remicade. This outcome met its prespecified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters.
No meaningful differences were observed in safety or immunogenicity. Complete details of the study, including secondary endpoints and full safety and immunogenicity data, will be released at an upcoming major medical meeting.
“Our mission at EPIRUS is to improve access to safe and effective biologic therapeutics for patients in emerging markets,” said Amit Munshi, the Company’s President and Chief Executive Officer. “The Phase 3 data announced today is an important milestones for us and underscores the technical competency of the EPIRUS team. We plan to submit regulatory filings in targeted emerging markets over the next 12 months.”
“The data supporting BOW-015’s clinical comparability to Remicade, combined with the focus of EPIRUS on emerging markets, will help expand patient access to this important medicine,” added Jonathan Kay, MD, Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School. Dr. Kay serves as a clinical advisor to EPIRUS.
About the study
This Phase 3 trial was a double-blind, active comparator study of the efficacy and safety of BOW-015 in patients with severe and active rheumatoid arthritis on stable doses of methotrexate. Strict inclusion criteria were applied, including CRP≥10mg/L, for all patients.
Subjects were randomized 2:1 in favor of BOW-015 (Total N= 189 subjects; 127 BOW-015: 62 Remicade). Patients received infusions of either BOW-015 (3 mg/kg) or Remicade (3 mg/kg) using the approved Remicade dosing regimen. Starting at Week 22, responders were crossed over into a single BOW-015 arm in an open-label phase. All patients will be followed for a total of 54 weeks in this open label phase.
The primary objective of this study was to determine whether BOW-015 is equivalent to Remicade in efficacy as indicated by ACR20 clinical response at Week 16.
The secondary objectives of this study were to determine the long-term efficacy, safety, and tolerability of BOW-015 up to Week 54, and to investigate the serum concentrations of infliximab BOW-015 and Remicade, as well as associated immunogenic response.
About EPIRUS Biopharmaceuticals
EPIRUS is developing a broad pipeline of biosimilar monoclonal antibodies and therapeutic proteins for commercialization in emerging markets.
This pipeline is designed for deployment in an In Market, For Market™ manufacturing configuration, which confers strategic and economic advantages in many key markets and regions.
In close partnership with companies in Brazil, South Africa, Russia, and other target markets, EPIRUS transfers product technology, designs and builds manufacturing capabilities, navigates local regulatory environments, and commercializes products.
Through coordinated global development and local production of its pipeline, EPIRUS will accelerate patient access to these important medicines.
SOURCE: Epirus Biopharmaceuticals
Post Views: 182
-
Comparability to Remicade as measured by ACR20 response in severe rheumatoid arthritis (RA) patients
-
No meaningful differences observed in safety or immunogenicity
-
First market authorization filing in Q4 2013
BOSTON, MA, USA I August 28, 2013 I EPIRUS Biopharmaceuticals, Inc. (EPIRUS), a privately held biotechnology company focused on the development and production of biosimilar products for major emerging markets, today announced positive Phase 3 data from a clinical trial comparing the EPIRUS infliximab molecule BOW-015 to Remicade for the treatment of rheumatoid arthritis (RA).
This study in severe RA patients was designed as an equivalence trial comparing BOW-015 to Remicade. BOW-015 achieved a week 16 ACR20 response rate of 89.8%, compared to 86.4% for Remicade. This outcome met its prespecified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters.
No meaningful differences were observed in safety or immunogenicity. Complete details of the study, including secondary endpoints and full safety and immunogenicity data, will be released at an upcoming major medical meeting.
“Our mission at EPIRUS is to improve access to safe and effective biologic therapeutics for patients in emerging markets,” said Amit Munshi, the Company’s President and Chief Executive Officer. “The Phase 3 data announced today is an important milestones for us and underscores the technical competency of the EPIRUS team. We plan to submit regulatory filings in targeted emerging markets over the next 12 months.”
“The data supporting BOW-015’s clinical comparability to Remicade, combined with the focus of EPIRUS on emerging markets, will help expand patient access to this important medicine,” added Jonathan Kay, MD, Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School. Dr. Kay serves as a clinical advisor to EPIRUS.
About the study
This Phase 3 trial was a double-blind, active comparator study of the efficacy and safety of BOW-015 in patients with severe and active rheumatoid arthritis on stable doses of methotrexate. Strict inclusion criteria were applied, including CRP≥10mg/L, for all patients.
Subjects were randomized 2:1 in favor of BOW-015 (Total N= 189 subjects; 127 BOW-015: 62 Remicade). Patients received infusions of either BOW-015 (3 mg/kg) or Remicade (3 mg/kg) using the approved Remicade dosing regimen. Starting at Week 22, responders were crossed over into a single BOW-015 arm in an open-label phase. All patients will be followed for a total of 54 weeks in this open label phase.
The primary objective of this study was to determine whether BOW-015 is equivalent to Remicade in efficacy as indicated by ACR20 clinical response at Week 16.
The secondary objectives of this study were to determine the long-term efficacy, safety, and tolerability of BOW-015 up to Week 54, and to investigate the serum concentrations of infliximab BOW-015 and Remicade, as well as associated immunogenic response.
About EPIRUS Biopharmaceuticals
EPIRUS is developing a broad pipeline of biosimilar monoclonal antibodies and therapeutic proteins for commercialization in emerging markets.
This pipeline is designed for deployment in an In Market, For Market™ manufacturing configuration, which confers strategic and economic advantages in many key markets and regions.
In close partnership with companies in Brazil, South Africa, Russia, and other target markets, EPIRUS transfers product technology, designs and builds manufacturing capabilities, navigates local regulatory environments, and commercializes products.
Through coordinated global development and local production of its pipeline, EPIRUS will accelerate patient access to these important medicines.
SOURCE: Epirus Biopharmaceuticals
Post Views: 182
