Conclusions
T1D
This first-in-human study showed that IMCY-0098 has a promising safety profile in patients with recent-onset T1D at all doses tested. The safety profile of IMCY-0098 supports further investigation and risk/benefit optimization for different doses and schedules of this novel treatment. This will be further evaluated in an ongoing phase 2 study (NCT: NCT04524949) with improved dosing and a higher sample size designed to provide clinical proof of concept of the Imotope™ technology as well as deeper characterization of the expected mechanism of action.