Cabaletta Bio's (CABA) experimental therapy, rese-cel, showed potential as a treatment for autoimmune diseases, including myositis, lupus and systemic sclerosis, based on new clinical data, the drugmaker said Wednesday.
A phase 1/2 myositis study showed that most patients with dermatomyositis and antisynthetase syndrome who stopped immunosuppressants have improved at 16 weeks, with some responses lasting up to 1.5 years, the company said.
In systemic sclerosis, patients showed improvements in lung and skin symptoms, and most reached meaningful response scores at 36 weeks while off immunosuppressants, the company said.
In lupus, patients who received pre-conditioning mostly stayed in remission at 12 months while off immunosuppressants and on low or no steroids, the company added.
Cabaletta said it plans to start a registrational systemic sclerosis study in late 2026 and expand development in lupus and pediatric programs.
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