2023-05-01 07:40:28 ET
- The U.S. Food and Drug Administration (FDA) granted fast track designation to Cabaletta Bio's ( NASDAQ: CABA ) CABA-201
- The drug is being developed to treat patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).
- SLE is an autoimmune disease in which the immune system attacks its own tissues, which leads to inflammation and tissue damage. LN is a type of kidney disease caused by SLE.
- The company said CABA-201 is to be given as a one-time infusion, to evaluate its potential to transiently but fully eliminate B cells, which will enable an immune system reset with durable remission in patients with SLE.
- "We look forward to initiating the Phase 1/2 trial for CABA-201 and further evaluating its therapeutic potential for patients in need," said Cabaletta's Chief Medical Officer David Chang.
For further details see:
Cabaletta's potential lupus drug CABA-201 gets FDA fast track tag