Biotech Values

[DewDiligence]

MNTA starts phase-1 trial of M281 anti-FcRn mAb:

http://finance.yahoo.com/news/momenta-pharmaceuticals-initiates-phase-1-120000781.html

Momenta Pharmaceuticals…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 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.