Cabaletta Bio Gets FDA's Nod For CABA-201 INDA For Generalized Myasthenia Gravis

(RTTNews) - Clinical-stage biotechnology company Cabaletta Bio, Inc. (CABA) Monday announced that FDA has allowed its Investigational New Drug or IND application for CABA-201 to proceed for a Phase 1/2 study in patients with generalized myasthenia gravis.

The Company plans one cohort of six patients with acetylcholine receptor antibody-positive generalized myasthenia gravis and a second cohort of six patients with AChR antibody-negative generalized myasthenia gravis.

Cabaletta said it remains on track to deliver initial clinical data from CABA-201-treated patients with lupus and/or myositis in the first half of 2024. It has plans to expand the CABA-201 portfolio beyond rheumatology and into neurology.

Myasthenia gravis is a rare autoimmune disease characterized by autoantibodies that interfere with signaling at the neuromuscular junction, leading to potentially life-threatening muscle weakness.