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BIO-Europe
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November 4–6, 2024 | Stockholm, SwedenNovember 12–13, 2024 | Digital Partnering

STALICLA SA

Profile

STALICLA is a clinical stage, precision molecular neuroscience biotech company with a mature pipeline for patients with Neurodevelopmental Disorders (NDDs) and Neuropsychiatric disorders. STALICLA’s unique approach addresses a principal weakness in the drug development process for NDD’s and neuropsychiatric disorders: behavior is a terrible biomarker. Clinical psychiatric and neurodevelopmental diagnoses encompass a broad diversity of underlying biology. This has contributed to drug development failure by diluting true responders in a population of patients with heterogeneous biology. STALICLA’s technology platform, DEPI, discovers biologically based endophenotypes within classical neuropsychiatric diagnostic groups. The AI/ML engine converges molecular data with human genetic information and non-behavioral clinical signs and symptoms, to define biologically related subgroups and create testable clinical hypotheses related to that biology. The DEPI platform has already completed several successful clinical validations, through the identification and biological validation of two distinct subgroups of patients with Autism Spectrum Disorder, ASD-Phenotype1 and ASD-Phenotype2, together with their predicted tailored treatment candidates (STP1 and STP2); as well as the blindly and retrospective calling “high” responder patients to previously failed drug candidates with high specificity, sensitivity and positive predictive value. Further the completion of STP1 Phase 1b in 2022, STP1 will enter clinical Phase 2 in late 2023; as well as STP2, a Phase 2 ready asset in licensed in Q4 ’22. Additionally, STALICLA is advancing STP7, a in-licensed Phase 3 ready asset from Novartis, with strong potential for neuropsychiatric indications. STALICLA has recently concluded a partnership with the National Institute on Drug Abuse/NIH covering the cost and clinical operations capacity to run a phase 3 trial in substance use disorders.