Momenta’s nipocalimab shows positive action in neuromuscular disorder

Momenta Pharmaceuticals (MNTA +0.9%) announces positive topline results from a proof-of-concept Phase 2 clinical trial, Vivacity-MG, evaluating nipocalimab (formerly M281) in patients with generalized myasthenia gravis (MG), a disorder characterized by weakness and rapid fatigue of skeletal muscles caused by disrupted communication between nerves and muscles.

All four treatment arms demonstrated efficacy as measured by the change from baseline in a scale of daily activities called MG-ADL at day 57, the primary endpoint. Specifically, 52% of treated patients experienced at least a two-point reduction in MG-ADL scores compared to 15% in the control arm (p=0.017).

On the safety front, nipocalimab was well-tolerated with no severe (grade 3) or worse treatment-related adverse events.

The trial should wind up next quarter. The company will announce 16-week data, along with duration of efficacy and analysis of secondary endpoints, in Q4.

The company plans to meet with regulators before year-end. A Phase 3 study will follow.

Nipocalimab is a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody engineered to reduce circulating IgG antibodies by blocking IgG recycling. MG is an antibody-mediated autoimmune disorder. Most (~80%) of MG sufferers have serum antibodies to acetylcholine receptors which leads to the disruption in communication between nerves and muscles.

https://seekingalpha.com/news/3582998-momentas-nipocalimab-shows-positive-action-in-neuromuscular-disorder