Momenta Pharmaceuticals Announces Publication of Phase 1 Study Data for Anti-FcRn Antibody, M281
Full data shows safety, tolerability and proof-of-mechanism in healthy volunteers
“We are encouraged by the rapid onset and duration of target receptor occupancy, maximal reduction of circulating IgGs, and dose-dependent effect observed in this study, which demonstrates that M281 safely functions as designed in healthy volunteers and validates its mechanism,” said
The Phase 1 randomized, double-blind, placebo-controlled single and multiple ascending dose study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in 50 healthy volunteers over a 98-day period. M281 exhibited rapid onset of target receptor occupancy, dose-dependent pharmacodynamics, a self-limited IgG decrease to a mean maximum percent reduction of approximately 84% of baseline, and loss of target occupancy and IgG recovery observed at consistent times after the last dose. Single doses up to 60 mg/kg or 15 or 30 mg/kg administered weekly for up to 4 weeks by intravenous infusion were well-tolerated with no serious adverse events, few moderate adverse events (AEs) and a low incidence of other AEs, similar to placebo treatment.
About M281, anti-FcRn antibody
M281 is a fully human anti-neonatal Fc receptor (FcRn), aglycosylated immunoglobulin G (IgG1) monoclonal antibody, engineered to reduce circulating pathogenic IgG antibodies, by blocking endogenous IgG recycling via FcRn. Momenta reported positive 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%. Momenta plans to commence two Phase 2 proof of concept studies, one in myasthenia gravis (MG) and one in hemolytic disease of the fetus and newborn (HDFN), in the fourth quarter of 2018.
Momenta is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases. Momenta’s lead product candidate, M281, is a potentially best-in-class anti-FcRn antibody; M254, is a hyper-sialylated human immunoglobulin (hsIgG) designed as a high potency alternative to intravenous immunoglobulin (IVIg); and M230 (CSL730), is a potential first-in-class novel recombinant Fc multimer being developed in collaboration with CSL. Momenta also has a focused pipeline of two biosimilar candidates: M710, a proposed biosimilar to EYLEA® being developed in collaboration with Mylan, and M923, Momenta’s wholly-owned proposed biosimilar to HUMIRA®. Momenta’s two
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Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about clinical development plans and timing for, market potential of, and safety and efficacy of M281. Forward-looking statements may be identified by words such as "believe," "continue," “plan to”, "potential," "will," and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors, including the risk that the costs of the restructuring actions will exceed the Company’s current expectations; the risk that the Company will not achieve the anticipated cost savings from the restructuring actions; and those referred to under the section "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended
MacDougall Biomedical Communications
Source: Momenta Pharmaceuticals, Inc.