January 8, 2018
Momenta Pharmaceuticals reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a Phase I single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well-tolerated and decreased circulating IgG levels up to 89% with a mean reduction of 84%. M281 is a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody, engineered to reduce circulating pathogenic IgG antibodies, in excess of that achieved by any current treatments, by completely blocking endogenous IgG recycling via FcRn. Momenta Pharmaceuticals will finalize development strategy and initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback. The Phase 1 randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of M281.