Cabaletta Bio Receives FDA Fast Track Designation for DSG3-CAART for the Treatment of mPV

The Company plans to initiate its Phase 1 DesCAARTes trial to evaluate the safety and tolerability of DSG3-CAART in relapsed and/or refractory patients in 2020.

The U.S. Food and Drug Administration (FDA) granted Cabaletta Bio’s DSG3-CAART (Desmoglein 3 Chimeric AutoAntibody Receptor T cells) Fast Track Designation for improving healing of mucosal blisters in patients with mPV.

DSG3-CAART is designed to specifically target the cause of mPV, B cells that express pathogenic autoantibodies directed against the DSG3 protein, while preserving normal B cell immune function.

“We believe that this Fast Track Designation, coming shortly after the Orphan Drug Designation for DSG3-CAART, further demonstrates that mPV is a devastating, rare disease for which patients have limited treatment options resulting in a large unmet need. The Fast Track Designation represents an important next step in our clinical development plans,” says David J. Chang, MD, Chief Medical Officer of Cabaletta, in a news release. “We appreciate the benefits provided by this designation, including the opportunity for increased access to the FDA and potential acceleration of our clinical development path and regulatory review process.”

The Company plans to initiate its Phase 1 DesCAARTes trial to evaluate the safety and tolerability of DSG3-CAART in relapsed and/or refractory patients in 2020. DSG3-CAART is based on technology licensed from and has been developed in collaboration with the University of Pennsylvania.

Check out Practical Dermatology® magazine’s April 2019 interview with Steven Nichtberger, MD co-founder, chief executive officer, and chairman of Cabaletta Bio.