Cabaletta Bio Receives Another FDA Clearance for IND application of CABA-201

Penn spinout Cabaletta Bio received FDA clearance for their fourth Investigational New Drug (IND) application of CABA-201, their CAR T cell investigational therapy, to treat patients with generalized myasthenia gravis.

Generalized myasthenia gravis (gMG) is a rare autoimmune disease characterized by profound muscle weakness, disabling fatigue, shortness of breath and risk for episodes of respiratory failure.

“Despite recent advances with chronic, broadly immunosuppressive therapies, we believe there is an unmet need for a treatment option like CABA-201 that may provide a deep and durable, perhaps curative, outcome with a single dose in patients with gMG,” said Steven Nichtberger, MD, Chief Executive Officer and Co-founder of Cabaletta, as per MyChesCo.

The company plans to initiate a Phase 1/2 clinical trial of CABA-201 in two cohorts of patients with generalized myasthenia gravis (gMG).

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