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Stalicla completes phase 1b trials into precision medicine for autism spectrum disorder

STP1 has demonstrated good safety and tolerability profiles, while also showing positive results for neurological function

Swiss clinical-stage biotech company, Stalicla, has announced the highly successful completion of phase 1b trials for its lead drug candidate, STP1.

The aim 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 autism spectrum disorder (ASD).

In addition to demonstrating good safety and tolerability profiles, and dose-dependent target engagement, STP1 treatment also showed positive signals in clinical markers of neurological and behavioural function, including improved processing speed and crystallised cognition composite.

Remarking on the results, Dr Craig Erickson, lead investigator at Cincinnati Children’s Hospital, explained: “The electrophysiological signals from this study are remarkable and represent the strongest early trial target engagement signals our lab has seen in the autism field. The findings from this project de-risk future larger-scale study given the personalised approach employed to biologically identify specific autistic individuals who may best respond to treatment prior to study enrolment.”

Baltazar Gomez Mancilla, Stalicla’s chief medical officer, said: “Beyond molecular impact, we are seeing a dose-related decrease of specific abnormal electrophysiological signal in brain regions related to social interaction, working memory and processing speed that may lead to social communication improvement, which is one of the core symptoms of autism.

“Those results and the prospects of a personalised solution addressing ASD could be a tremendous game-changer for this subgroup of patients representing 20% of the ASD population,” he added.

Looking to the future, Lynn Durham, Stalicla’s CEO & founder, concluded: “We are now turning our sights to the next stage of our growth with some major milestones. First, a multicentre bio sampling study for the enrolment of STP1 phase 2, which should allow us to gather the most comprehensive clinical and multi-omics data set to a date in the ASD space.”