CAMBRIDGE, MA, USA I June 09, 2016 I Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the dosing of the first healthy volunteers in a Phase 1 randomized, double-blind, placebo-controlled, ascending-dose cohort study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281, an anti-FcRn monoclonal antibody, for the treatment of autoimmune diseases.
“The preclinical data we presented at ASH in December 2015 supported the evaluation of M281 as a strategy for the rapid and reversible suppression of pathogenic autoantibodies or alloantibodies in the setting of a variety of autoimmune diseases,” said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. “The initiation of this trial advances our initiative to develop a best-in-class monoclonal antibody for the treatment of antibody-mediated diseases with high unmet medical needs. We anticipate presenting the data from this trial in the second half of 2017.”
M281 is a fully human IgG1 monoclonal antibody that targets the IgG-binding site of FcRn. In preclinical models, M281 potently antagonizes FcRn binding of IgGs and rapidly diminishes circulating levels of IgG antibodies, the primary pathogenic agent in a number of autoimmune diseases.
This study will enroll up to approximately 72 healthy volunteers depending on the number of cohorts enrolled. Part 1 of the study will assess ascending doses of M281 administered as a single dose. Part 2 will assess ascending doses of M281 administered as repeated weekly or twice-weekly doses over 28 days.
About Momenta Pharmaceuticals
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. The company’s logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
SOURCE: Momenta Pharmaceuticals
Post Views: 308
CAMBRIDGE, MA, USA I June 09, 2016 I Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the dosing of the first healthy volunteers in a Phase 1 randomized, double-blind, placebo-controlled, ascending-dose cohort study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281, an anti-FcRn monoclonal antibody, for the treatment of autoimmune diseases.
“The preclinical data we presented at ASH in December 2015 supported the evaluation of M281 as a strategy for the rapid and reversible suppression of pathogenic autoantibodies or alloantibodies in the setting of a variety of autoimmune diseases,” said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. “The initiation of this trial advances our initiative to develop a best-in-class monoclonal antibody for the treatment of antibody-mediated diseases with high unmet medical needs. We anticipate presenting the data from this trial in the second half of 2017.”
M281 is a fully human IgG1 monoclonal antibody that targets the IgG-binding site of FcRn. In preclinical models, M281 potently antagonizes FcRn binding of IgGs and rapidly diminishes circulating levels of IgG antibodies, the primary pathogenic agent in a number of autoimmune diseases.
This study will enroll up to approximately 72 healthy volunteers depending on the number of cohorts enrolled. Part 1 of the study will assess ascending doses of M281 administered as a single dose. Part 2 will assess ascending doses of M281 administered as repeated weekly or twice-weekly doses over 28 days.
About Momenta Pharmaceuticals
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. The company’s logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
SOURCE: Momenta Pharmaceuticals
Post Views: 308
