“The electrophysiological signals from this study are remarkable and represent the strongest signals of engagement of the initial trial target that our laboratory has seen in the field of autism.”Stalicla, a Swiss clinical stage biotechnology company, announced the highly successful completion of phase 1b studies for its drug STP1.
The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of a two-week oral treatment with this drug in a subgroup of patients with autism spectrum disorder (ASD).
In addition to demonstrating good safety and tolerability profiles, treatment with STP1 also showed positive signals in clinical markers of neurological and behavioral function, including improved processing speed and crystallization of composite cognition.
Commenting on the results, Dr. Craig Erickson, principal investigator at Cincinnati Children’s Hospital, explained, “The electrophysiological signals from this study are remarkable and represent the strongest signals of engagement of the initial trial target that our laboratory has seen in the field of autism.”
Baltazar Gomez Mancilla, medical director of Stalicla, said, “Beyond the molecular impact, we are seeing a dose-related decrease in the abnormal electrophysiological signal precisely in brain regions related to social interaction, working memory and processing speed that may lead to improved social communication, which is one of the main symptoms of autism.”
“These findings and the prospects for a personalized solution to address Autism Spectrum Disorder could be a huge game-changer for this subgroup of patients who represent 20% of the DSA population,” she added.
Looking ahead, Lynn Durham, CEO and founder of Stalicla, concluded, “We are now turning our eyes to the next phase of our growth with some important milestones. First, a multicenter biosampling study to enroll STP1 phase 2, which should allow us to collect the most comprehensive clinical and multi-omic data to date in the DSA space.”
