STALICLA, a Swiss clinical stage biotech company leading omics-based drug development for patients with neurodevelopmental disorders (NDDs), announced today the highly successful completion of the phase 1b trials for its lead drug candidate STP1. These clinical data clear the way for a first application of STALICLA’s precision medicine discovery platform in autism spectrum disorders.
The goal of this phase 1b, double-blind, placebo-controlled study was to evaluate the safety, tolerability, and pharmacokinetics of a two-week oral treatment with STP1 in a subgroup of patients with ASD. In addition to showing good safety and tolerability profiles, and dose-dependent target engagement, STP1 treatment resulted in positive signals in clinical markers of neurological and behavioral function, including improved processing speed and crystallized cognition composite.