Cabaletta Bio: IND Application For CABA-201 Gets FDA Clearance To Treat Systemic Sclerosis

(RTTNews) - Cabaletta Bio, Inc. (CABA), a clinical-stage biotechnology company focused on targeted cell therapies for patients with autoimmune diseases, announced Monday that the U.S. Food and Drug Administration has cleared its third Investigational New Drug or IND application for CABA-201.

The FDA has allowed to proceed CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for a Phase 1/2 study in patients with systemic sclerosis or Ssc.

SSc is a rare and potentially fatal chronic autoimmune disease characterized by progressive skin and internal organ fibrosis that can be life-threatening.

The company said it plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel SSc cohorts. These are one cohort of six patients with severe skin manifestations and a separate cohort of six patients with severe organ involvement associated with systemic sclerosis.

Steven Nichtberger, Chief Executive Officer and Co-founder of Cabaletta said the company believes CABA-201 has the potential to slow or halt the progression of this autoimmune disease.

Nichtberger added, "As we remain on track to deliver three-month clinical data from the initial patients treated with CABA-201 by the first half of 2024, the clearance of our third IND application for CABA-201 within the past 6 months demonstrates our relentless focus on developing CABA-201 for a broad portfolio of potential indications in patients with autoimmune diseases."

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