All six adult dermatomyositis patients maintained immunomodulator-free moderate-to-major responses through one year, and 67% were steroid-free. Cabaletta Bio expects RESET-Myositis topline results in the second half of 2027 and has operational runway into the first quarter of 2028.
Cabaletta Bio presented rese-cel data showing all six adult dermatomyositis patients maintained immunomodulator-free moderate-to-major responses through one year; 67% were steroid-free. Safety data from 71 patients showed 94% had no cytokine release syndrome or only grade 1 events, while 96% had no neurotoxicity syndrome.
The company expects topline results from its registrational RESET-Myositis study in the second half of 2027 and is targeting a myositis biologics license application in the first quarter of 2028. It expects to outline a development strategy for its preconditioning-free approach in the first half of 2027, and said its operational runway extends into the first quarter of 2028, covering anticipated milestones.