STALICLA publishes groundbreaking phase 1b data on precision autism treatment in Biomedicines

STALICLA’s precision psychiatry study demonstrates strong EEG-based responses to STP1 treatment within a defined subgroup of autism patients and numerical improvements in core symptoms.

June 27, 2024 – STALICLA SA, a Swiss company focused on precision medicine for neuropsychiatric and neurodevelopmental disorders, announced the results of a groundbreaking Phase 1b study involving STP1, a new combination therapy designed for a specific subgroup of autism spectrum disorder (ASD) patients called ASD Phenotype 1 (ASD-Phen1).

The findings were published in the peer-reviewed journal Biomedicines under the title, “Safety, Tolerability, and EEG-Based Target Engagement of STP1 (PDE3,4 Inhibitor and NKCC1 Antagonist) in a Randomized Clinical Trial in a Subgroup of Patients with ASD.”

Lynn Durham, CEO of STALICLA, expressed, “This study signifies a crucial milestone in advancing precision medicine for ASD. It represents the first stratification-based approach for clinical development in neurodevelopmental disorders, showcasing the potential of precision medicine in ASD.”

The Phase 1b clinical trial was randomized, double-blind, and placebo-controlled, assessing the safety and tolerability of STP1, a combination of ibudilast and bumetanide, in ASD-Phen1 patients. Registered at clinicaltrials.gov (NCT04644003), the trial involved two 14-day treatment phases where ASD-Phen1 patients received either STP1 or a placebo.

The study found that STP1 was well-tolerated with no significant adverse effects. There were significant dose-dependent reductions in gamma power throughout the brains of patients on STP1, particularly in areas related to executive function and memory. Furthermore, STP1 increased alpha 2 power in frontal and occipital regions and improved habituation and neural synchronization to auditory stimuli.

Dr. Craig A. Erickson, Associate Professor at UC's Department of Psychiatry and Behavioral Neuroscience at Cincinnati Children's Hospital Medical Center and principal investigator of the study, commented, “The electrophysiological signals from this study are exceptional and represent the strongest early trial target engagement signals our lab has observed in autism research.”

Dr. Laura Pérez-Cano, Head of Discovery at STALICLA and co-author of the study, stated, “These results not only highlight the potential of STP1 as a treatment for ASD-Phen1 patients but also emphasize the importance of combining biologically-based patient stratification with measurable outcomes like EEG that can be correlated with behavioral measures.”

By targeting a biologically defined subgroup of ASD patients, STALICLA is advancing personalized treatment options for those with ASD. This approach holds the promise to revolutionize ASD and other neuropsychiatric disorder treatments.

STALICLA is a clinical-stage biotechnology company dedicated to precision medicine for brain disorders. The company has created a unique neuro precision development platform, DEPI, which has undergone clinical validation for its first indication: Autism Spectrum Disorder. STALICLA’s primary neurodevelopmental disorder asset, STP1, is progressing into Phase 2 trials. Their leading neuropsychiatry asset, STP7 (Mavoglurant), funded by the US government, is set to be Phase 3-ready for treating Cocaine Use Disorder.