Cabaletta Bio (CABA) has released an update.
Cabaletta Bio announced that the FDA has granted Orphan Drug Designation to its investigational therapy CABA-201, targeting idiopathic inflammatory myopathies (IIM), which are autoimmune conditions affecting muscle tissue. The therapy, part of the RESET Phase 1/2 trials, aims to induce remission by resetting the immune system through a one-time infusion designed to deplete B cells. CABA-201 has received FDA clearance for multiple autoimmune conditions, with ongoing parallel Phase 1/2 trials across nine cohorts. Myositis, the primary focus, affects about 66,000 patients in the US and can lead to severe impairment or be life-threatening, with many cases resistant to current treatments.
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For a comprehensive understanding of the announcement, you can read the full document here.
