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Organic Cabaletta (NASDAQ:CABA) traded sharply lower on Friday after the cell therapy developer announced initial results from two Phase 1/2 trials for its lead candidate CABA-201 in patients with immune disorders, myositis and systemic lupus erythematosus (SLE).
The RESET-Myositis and The RESET-SLE trials were designed to evaluate the safety and tolerability of CABA-201 within 28 days of infusion.
The readout, which represents a May 28 data cutoff from two patients with immune-mediated necrotizing myopathy and SLE, indicated a well-tolerated safety profile with no serious adverse events, Cabaletta (CABA) said, citing follow-up of up to three months. .
According to the company, there were no signs of cytokine release syndrome (CRS), an immune reaction commonly linked to immunotherapy drugs such as CAR-T cell therapy.
Cabaletta (CABA) is advancing single infusion in four Phase 1/2 RESET trials comprising ten arms. Six patients are expected to be enrolled in each group. As of June 12, 2024, the total number of registrations was five.
