Pharma Focus Asia

STALICLA Completes Successful Phase 1b Trials for the First Precision Medicine in Autism Spectrum Disorder

Friday, March 25, 2022

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.

Speaking about the results, Dr Craig Erickson, M.D. – lead investigator at Cincinnati Children’s Hospital said: “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 personalized approach employed to biologically identify specific autistic individuals who may best respond to a treatment prior to study enrollment.”

Baltazar Gomez Mancilla, STALICAL’s CMO, added: “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 personalized solution addressing ASD could be a tremendous game-changer for this subgroup of patients representing 20% of ASD population.”

STALICLA drug development relies on DEPI, the AI-driven and clinically validated biotech platform integrating comprehensive metabolomics, whole-genome sequencing, RNA sequencing and a proprietary module to pair patient biological signatures with drug candidates. Using DEPI, STALICLA already proved the clinical validity of several subgroups with neurodevelopmental disorders (Phen1, Phen2, Phen3, Phen5) and their respective tailored treatments, starting with STP1.

Speaking about next steps, Lynn Durham, STALICLA’s CEO & Founder, commented: “We are now turning our sights to the next stage of our growth with some major milestones. First, a multicenter bio sampling study for the enrollment of STP1 phase 2, which should allow us to gather the most comprehensive clinical and multi-omics data set to date in the ASD space. Then, the continuation of STP1 phase 2, increasing treatment duration and dose level, adding a working memory test, and further refining phase 1b's strong findings. Finally, our other milestones will include phase 2 trials for our second precision drug candidate STP2, partnerships’ development and the in-licensing of potential additional compounds. In order to finance this growth, we are currently raising a series B of USD 65M, with target completion Q2-Q3 2022.”

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