Momenta Pharmaceuticals…today reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a phase 1 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.
CEO, Craig Wheeler considers M281 to be MNTA’s most promising new-drug candidate (exceeding even M230, which is partnered with CSL). The scientific rationale for the program is in #msg-133024075.
This PR was issued Friday morning, causing MNTA to break its 12-month high.
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