Momenta announces anticipated 2020 milestones
Momenta Pharmaceuticals provided a 2019 year-end corporate update and key anticipated milestones for 2020. Overview of Programs and Anticipated 2020 Milestones: M254: a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin : The Company's multi-part Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura has completed Part A and is progressing through Part B, which is evaluating M254 in a single ascending dose cohort of ITP patients, followed by 1,000 mg/kg of IVIg. Five of six ITP patients administered M254 responded and exhibited platelet counts greater than=50 x 109/L. Based on early favorable responses to M254 and variable responses to IVIg, the Company is augmenting the number of patients in the Part B cohorts and including a lower dose cohort. Enrollment is ongoing and the Company expects to report additional data from Part B of the study in the second quarter of 2020. The Company also plans to initiate a clinical study of M254 in chronic inflammatory demyelinating polyneuropathy later in 2020. Nipocalimab: a fully human anti-neonatal Fc receptor aglycosylated immunoglobulin Gmonoclonal antibody. Vivacity-MG, the Company's Phase 2 clinical study of nipocalimab in generalized myasthenia gravis, continues to enroll patients, with 80% of the trial enrolled. The Company expects to report top-line data from this study in the third quarter of 2020. Unity, the Company's global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn, is actively enrolling patients, with four patients currently enrolled. The Company expects to report top-line data from this study in 2021. Energy, the Company's adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia commenced in the third quarter 2019. The Company is activating clinical sites in both the United States and European Union and is enrolling patients. Nipocalimab has been granted Fast Track and Orphan Drug designation by the FDA in this indication and the Company expects to report top-line data from this study around the end of 2021. M230: a recombinant Fc multimer being developed in collaboration with CS. A Phase 1 clinical trial to evaluate the safety and tolerability of M230 in healthy volunteers is ongoing and Momenta's partner, CSL, looks forward to introducing a subcutaneous formulation into the phase 1 program. Momenta's SIFbody platform combines multiple Fc's with antibody fabs to optimally activate Fc and complement effector function and effectively deplete target cells. CD38 is a target on plasmacytes, immune system cells responsible for generating autoantibodie and M protein. Pre-clinical data suggests this CD38 SIFbody has the potential to be a best-in-class therapeutic for the management of plasmacyte-mediated diseases such as multiple myeloma, AL amyloidosis and rare, auto-antibody-mediated diseases. The Company has nominated an early development CD38 SIFbody candidate and expects to initiate IND enabling studies in 2020.