Date: 2016-11-02
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Mylan (USA - PA) Momenta Pharmaceuticals (USA - MA)
Product: M834
Action
mechanism: biosimilar/fusion protein. M834 is a proposed biosimilar of Orencia® (abatacept). Abatacept is a soluble fusion protein, which links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc portion of human immunoglobulin G1 (IgG1). The drug has activity as a selective co-stimulation modulator with inhibitory activity on T lymphocytes.
Disease:
Therapeutic area:
Country: UK
Trial
details: The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia® following administration of a single-dose in healthy volunteers. (NCT02923583)
Latest
news: * On November 2, 2016, Momenta Pharmaceuticals and Mylan announced that dosing has begun in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834, a proposed biosimilar of Orencia® (abatacept), to US- and EU-sourced ORENCIA in normal healthy volunteers. Under the Momenta-Mylan collaboration agreement agreement, Momenta has achieved the milestone necessary to earn a $25 million payment from Mylan. The Phase 1 study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 300 healthy volunteers. The companies plan to report top-line data from this study by the end of 2017.
