Cabaletta Bio receives FDA clearance for fourth CABA-201 IND, now in generalized myasthenia gravis

Cabaletta Bio, Inc.

FDA cleared IND for CABA-201 in generalized MG; fourth IND across autoimmune diseases.
Phase 1/2 trial to enroll 12 patients in two parallel cohorts: AChR+ (n=6) and AChR- (n=6).
Starting dose remains 1 x 10^6 cells/kg, consistent with lupus, myositis, and systemic sclerosis trials.
gMG affects ~85% of an estimated 50,000-80,000 MG patients in the U.S.
Company expects initial clinical data from lupus/myositis trials in H1 2024.

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