In the KYSA-8 trial, a single infusion of miv-cel delivered sustained improvements across both primary and secondary measures of Stiff Person Syndrome.
Kyverna Therapeutics, Inc. (KYTX) shares drew significant investor attention on Monday morning after the company announced promising outcomes from its registrational Phase 2 study of the experimental CAR T-cell therapy mivocabtagene autoleucel (miv-cel) in patients with stiff person syndrome.
Stiff person syndrome is a rare and disabling autoimmune condition with no approved treatments.
Positive Trial Outcomes
In the KYSA-8 trial, a single infusion of miv-cel delivered sustained improvements in both primary and secondary disease measures. The 26 participants enrolled in the study were followed through the main analysis at 16 weeks, with additional observations continuing thereafter.
According to the topline data, patients experienced statistical gains in mobility and function. For the primary timed 25-foot walk endpoint, median performance improved 46% compared with baseline, with 81% surpassing a clinically meaningful threshold.
Following the trial outcome, Kyverna’s stock traded over 11% higher in Monday’s premarket.
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