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 technology platform, DEPI, discovers biologically based endophenotypes within classical neuropsychiatric diagnostic groups.
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 ( worth ∼ $25 million) 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.
STALICLA is currently preparing its next stage of growth, to advance its pipelines and scale its platform.
STALICLA’s technology platform, DEPI, discovers biologically based endophenotypes within classical neuropsychiatric diagnostic groups.
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 ( worth ∼ $25 million) 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.
STALICLA is currently preparing its next stage of growth, to advance its pipelines and scale its platform.
Company Type:
Privately Funded Company
Company Website:
Company HQ State:
Geneva
Company HQ Country:
Switzerland
Year Founded:
2017
Main Therapeutic Focus:
CNS/Neurological
Lead Product in Development:
· DEPI (Databased Endophenotyping Patient Identification): 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.
· STP1: a fixed dose combination PDE4/3 inhibitor and NKCC1 inhibitor. STP1 is the first precision medicine candidate tailored to DEPI-identified ASD-Phenotype 1 subgroup. STP1 completed Phase1b in 2022 and will enter Phase 2 in late 2023 - STP1 market entry is expected late 2027 with a market potential > 1Bn.
· STPP2 (SFX-01, Sulforadex; in licensed from Evgen Pharma): a synthetic stabilized from of sulforaphane. STP2 is the second precision medicine candidate tailored to DEPI-identified ASD-Phenotype 2 subgroup. STP2 will enter Phase 2 in Q4 2023 – STP2 market entry us expected early 2028 with a market potential > 1Bn.
· STPP7 (mavoglurant, in licensed from Novartis): a mGluR5 antagonist with strong potential for neuropsychiatric disorders (substance use disorders) and neurodevelopmental disorders. STP7 will be advanced toward cocaine use disorder Phase 3 in 2024. CUD clinical development with be funded by US agency.
Development Phase of Primary Product:
Phase III
Number Of Unlicensed Products (For Which You Are Seeking Partners):
Not Provided
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