Stalicla SA, a Swiss neuro precision biotech company specializing in precision medicine for neuropsychiatric and neurodevelopmental disorders, has announced the publication of a significant phase 1b study on STP1. This novel combination therapy is tailored for treating a specific subgroup of patients with autism spectrum disorder (ASD) known as ASD Phenotype 1 (ASD-Phen1).
Published in the peer-reviewed journal Biomedicines under the title “Safety, Tolerability, and EEG-Based Target Engagement of STP1 (PDE Inhibitor and NKCC1 Antagonist) in a Randomized Clinical Trial in a Subgroup of Patients with ASD,” the study highlights strong EEG-based target engagement and promising improvements in core symptoms with STP1 treatment.
Lynn Durham, CEO of Stalicla, emphasized the study’s significance: “This marks a major milestone in advancing precision medicine for ASD, employing a unique approach to clinical development in neurodevelopmental disorders.”
The randomized, double-blind, placebo-controlled phase 1b trial assessed STP1’s safety and efficacy in ASD-Phen1 patients, involving two 14-day treatment phases. Results indicated that STP1 was well-tolerated with no significant adverse effects. Patients treated with STP1 showed notable reductions in gamma power across key brain regions associated with cognitive function, alongside improvements in alpha 2 power and neural synchronization in response to auditory stimuli.
Dr. Craig A. Erickson, Principal Investigator of the study, noted: “The electrophysiological responses observed are remarkable and represent significant early signals of target engagement in ASD research.”
Dr. Laura Pérez-Cano, co-author of the study, added: “These findings underscore the potential of STP1 as a therapeutic option for ASD-Phen1 patients, emphasizing the importance of biological stratification and objective measures like EEG.”
By focusing on biologically defined subgroups, Stalicla aims to advance personalized treatments for ASD, potentially transforming care for ASD and related neuropsychiatric conditions.