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news.Momenta Pharmaceuticals 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.
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"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.