Cabaletta Bio receives FDA clearance for second CABA-201 IND, Phase 1/2 trial in myositis

Cabaletta Bio, Inc.

FDA cleared IND for CABA-201 in active idiopathic inflammatory myopathy (myositis); second IND clearance within two months.
Phase 1/2 trial to enroll 18 patients across three subtypes: dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy.
Initial dose 1 x 10^6 cells/kg, informed by preclinical data and Lancet Rheumatology publication.
Myositis subtypes impact ~66,000 patients in US; current treatments often inadequate.

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