Momenta reports first subject dosed in Phase 1/2 trial of M254

Momenta Pharmaceuticals announced the dosing of the first subject in the Phase 1/2 clinical trial of M254, hypersialylated Immunoglobulin G. The Phase 1/2 study will enroll normal healthy volunteers and patients with Immune Thrombocytopenic Purpura. The multi-part study includes single and multiple dose parts, and a placebo-controlled, randomized double-blinded cross-over study comparing M254 to IVIg. The four part study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of intravenous 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.

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