Geneva, Switzerland – October 26th, 2022, STALICLA SA, a precision neuroscience clinical stage biotech, advancing the first precision medicine platform (DEPI) for patients with Neurodevelopmental Disorders (NDDs), today announced first patient visits in its new STA-B-001 clinical observational-biosampling study in Spain and USA.

STALICLA’s unique approach addresses a major weakness in the drug development process for NDDs and neuropsychiatric disorders: behaviour is a terrible biomarker. Thanks to DEPI, a proprietary platform aggregating molecular data and human genetic information, STALICLA pushes the frontier of precision medicine further into precision NDDs. DEPI has already reached validation through the clinical identification of biologically defined subgroups of patients with ASD, ASD-Phenotype 1 and ASD-Phenotype 2, and their respective candidate treatments, STP1 and STP2.

The biosampling clinical study, STA-B-001, is a multicenter, international study involving 12 clinical sites in the USA and Europe and targeting to enrol up to 1’200 patients diagnosed with ASD. This study follows a previous biosampling study conducted at Cincinnati Children Medical Center which permitted the clinical validation of ASD-Phenotype 1 and ASD- Phenotype 2, the first DEPI-identified biological subgroups of patients with ASD.

This new multicenter study will serve multiple purposes including:

• the identification of patients eligible for recruitment in STALICLA’s upcoming STP1 and STP2 Phase 2 studies planed in 2023;
• the validation of blood-based biomarkers for each subgroup;
• the enrichment of STALICLA’s database with comprehensive clinical and biological datasets to support the identification of new subgroup(s) of patients eligible for precision medicine.

STALICLA’s pipeline includes, STP1 is a proprietary fixed dose combination of PDE4/3 inhibitor and NKCC1 antagonist tailored to ASD-Phenotype1. STP2 (SFX-01), is a patented composition of sulforaphane and alpha cyclodextrin, and the only grade of sulforaphane suitable for clinical research and possible approval asmedicine. STALICLA has recently in-licensed SFX-01 rights for NDDs from Evgen Pharma.