Momenta Pharmaceuticals Announces First Subject Dosed in Phase 1/2 Clinical Trial of M254, Hypersialylated Immunoglobulin G
CAMBRIDGE, Mass., Jan. 29, 2019 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced the dosing of the first subject in the Phase 1/2 clinical trial of M254, hypersialylated Immunoglobulin G (hsIgG). The Phase 1/2 study will enroll normal healthy volunteers and patients with Immune Thrombocytopenic Purpura (ITP). The multi-part study includes single and multiple dose parts, and a placebo-controlled, randomized double-blinded cross-over study comparing M254 to IVIg.
“We believe M254 has the potential to be a significantly better option for patients than conventional IVIg. Our aim for this study is to show clinically what we have observed in extensive preclinical models, which is that hypersialylated IgG is substantially more potent than intravenous immunoglobulin G (IVIg) in ITP and other inflammatory disorders,” said Santiago Arroyo, M.D., Ph.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. “We look forward to obtaining initial clinical data in the first half of 2020.”
The four part study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of intravenous (IV) M254 in approximately 65 subjects, including healthy volunteers and patients with ITP. Parts A and B are double-blind, placebo-controlled, single ascending dose cohort studies in healthy volunteers and ITP patients, respectively. In Part C, ITP patients will receive M254 or IVIg in a cross-over dosing design, while in Part D, ITP patients will receive multiple doses of M254. The primary efficacy endpoint is an assessment of platelet response.