Subcutaneous batoclimab in generalized myasthenia gravis: Results from a Phase 2a trial with an open-label extension.

Abstract in brief

• The study assessed the safety, tolerability, and effects of subcutaneous batoclimab, a monoclonal antibody targeting the neonatal Fc receptor, in patients with generalized myasthenia gravis (MG) and antiacetylcholine receptor antibodies, showing significant reductions in harmful antibodies without safety concerns.
• In a Phase 2a trial, patients received either 340mg, 680mg of batoclimab weekly or a placebo for 6 weeks, with all eventually entering an extension where they received 340mg every two weeks, and results indicated promising antibody level reductions and possible clinical improvements, though the study wasn't large enough to confirm efficacy.
• Overall, the findings suggest that batoclimab is safe and effective at lowering adverse immune factors in MG, supporting further research into its therapeutic potential for this disease.]