Clinical Trials

Date: 2018-01-05

Type of information: Results

phase: 1

Announcement: results

Company: Momenta Pharmaceuticals (USA - MA)

Product: M281

Action mechanism:

  • monoclonal antibody. 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. 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.

Disease: autoimmune diseases

Therapeutic area: Autoimmune diseases

Country: The Netherlands

Trial details:

  • The Phase 1 randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of M281.
  • SAD: The single ascending dose portion of the study enrolled five cohorts with a total of 34 healthy adult volunteers and showed that a single dose of M281 achieved up to an 80% reduction of circulating IgG antibodies.
  • MAD: The multiple ascending dose portion of the study assessed M281 in two cohorts, administered in four weekly doses to 16 healthy adult volunteers and showed predictable pharmacokinetics, and commensurate, controllable and reproducible reductions in circulating IgG. The data showed greater than 80% reduction in circulating IgG antibodies with a mean reduction of 84%. (NCT02828046)

Latest news:

  • • On January 5, 2018, Momenta Pharmaceuticals reported  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 was well tolerated at all dose levels and no serious adverse events or unexpected safety findings were observed in either portion of the study. Full data from the Phase 1 study will be presented at an upcoming Company presentation and future medical congresses.
  • Momenta Pharmaceuticals plans to initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback.
  • • On June 9, 2016, 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. 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.

Is general: Yes