Cabaletta Bio’s CABA-201 Receives the US FDA’s Orphan Drug Designation to Treat Systemic Sclerosis
Shots:
- The US FDA has granted ODD to the company’s CABA-201 for treating systemic sclerosis (SSc). CABA-201 is being evaluated under a series of P-I/II (RESET) studies, incl. RESET-SSc, for addressing various autoimmune diseases
- The P-I/II (RESET-SSc) trial assesses CABA-201 (1 x 10^6 cells/kg, single infusion) to treat SSc across 2 arms, severe skin arm for patients (n=6) with severe skin involvement & the organ arm for patients (n=6) meeting the pulmonary, cardiac, or renal involvement criteria irrespective of skin involvement
- CABA-201 is developed to decrease CD19+ B cells after a single infusion enabling an immune system reset for durable remission off therapy in patients with autoimmune diseases
Ref: Cabaletta | Image: Cabaletta
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
