Publications & Scientific Posters

You can access the following presentations, publications and poster content by hovering over reference titles and clicking on the hyperlinks. Note: Some posters may not be available.

Posters

American Epilepsy Society 2023:

• Analysis of Physician Notes to Examine the Clinical and Humanistic Burden of Patients with Dravet Syndrome and Lennox-Gastaut Syndrome in the United States
• Caregiver-reported Overall Treatment Experience and Change in Non-seizure Symptoms/Impacts in the ENDYMION 1 Study of Soticlestat (TAK-935) in Individuals with Dravet or Lennox-Gastaut Syndromes
• Soticlestat in Vitro Metabolism and Drug-Drug Interactions: Comprehensive Investigations Display Minimal Notable Interactions
• Real World Treatment Patterns and Outcomes Among Patients with Dravet Syndrome
• Treatment Patterns and Outcomes Among Patients with Lennox-Gastaut Syndrome from Real-World Clinical Practice Settings Across the USA, Europe, and Asia
• Real-World Clinical Burden of Non-seizure Symptoms on Patients with Dravet or Lennox-Gastaut Syndromes: Results from a Global Multinational Survey
• Cognitive Debriefing of the Quality-of-Life Inventory – Disability with Caregivers of Patients with Dravet and Lennox-Gastaut Syndromes
• Antiseizure Medication Treatment Patterns, Reasons for Disruption, and Side Effects for Patients with Dravet Syndrome or Lennox-Gastaut Syndrome: A Retrospective Analysis of US Physician Notes
• Physiologically Based Pharmacokinetic Modeling to Predict Drug–Drug Interactions of Soticlestat
• Proposed Mechanism of Action of Soticlestat as an Antiseizure Medication

American Academy of Neurology 2023:

• Long-Term Treatment Effects of Soticlestat in Patients with Dravet Syndrome or Lennox–Gastaut Syndrome: Interim Data from the ENDYMION 1 Trial
• Efficacy of Soticlestat Treatment by Seizure Type in Patients with Dravet Syndrome or Lennox–Gastaut Syndrome in a Phase 2, Randomized, Placebo-controlled Study (ELEKTRA)

American Epilepsy Society 2022:

• Development of a Novel Clinical CGI measure for clinical outcome assessment of nonseizure symptoms in LGS and DS
• Absolute Bioavailability and Mass Balance of the CH24H Inhibitor Soticlestat in Healthy
• Effects of Intraconazole, Mefenamic Acid and Rifampicin on the PK of the CH24H inhibitor Soticlestat: Two Drug-drug Interaction Studies in Healthy Volunteers

American Epilepsy Society 2021:

• Major Motor Drop Seizures for Endpoint Assessments in a Phase 3 Trial of Soticlestat in Individuals with Lennox-Gastaut Syndrome

American Academy of Neurology 2021:

• Long-Term Soticlestat Treatment in Patients with Developmental and/or Epileptic Encephalopathies in the ENDYMION Ongoing Open-Label Extension Study
• Efficacy, Safety and Tolerability of Soticlestat (TAK-935/OV935) as an Adjunctive Therapy in Patients with 15q Duplication Syndrome (Dup15q) or Cyclin-Dependent Kinase-Like 5 Deficiency Disorder (CDD) in a Signal-Finding Phase 2 Study (ARCADE)

American Epilepsy Society 2020:

• Efficacy, Safety and Tolerability of Soticlestat (TAK-935/OV935) as Adjunctive Therapy in Pediatric Patients with Dravet Syndrome and Lennox-Gastaut Syndrome (ELEKTRA)

American Academy of Neurology 2020:

• A Phase Ib/IIa Study of TAK-935 (OV935) as Adjunctive Therapy in Patients with Developmental and Epileptic Encephalopathies

American Epilepsy Society 2019:

• TAK-935 (OV935) Exerts Neuroprotective and Disease-Modifying Effects in a Murine Model of Epileptogenesis

American Epilepsy Society 2018:

• Cognitive Assessment After Multiple Ascending Doses of TAK-935 (OV935) in Healthy Subjects
• Evaluation of TAK-935 (OV935) on seizures and survival in Scn1a+/-Dravet Mice

American Epilepsy Society 2017:

• Inhibition of Cholesterol 24-Hydroxylase Is a Novel Pharmacological Strategy for Epilepsy Treatment
• Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of TAK-935 in Healthy Subjects
• Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of TAK-935 in Healthy Subjects
• Inhibition of Cholesterol 24-Hydroxylase Improves the Survival of a Mouse Model of Epileptic Phenotype and Modulates Extracellular Levels of Glutamate
• Clinical Trial Simulations Using a Pharmacokinetic/Enzyme-Occupancy/Pharmacodynamic Model of TAK-935, a Cholesterol 24S- Hydroxylase Inhibitor

Publications

• Yin W, Facius A, Asgharnejad, M, Lahu, G. “Population pharmacokinetics, enzyme occupancy, and pharmacodynamic modeling of soticlestat in patients with developmental and epileptic encephalopathies. Clin Transl Sci 2024;17:e13722
• Effects of Strong Inhibition of Cytochrome P450 3A and UDP glucuronosyltransferase 1A9 and Strong Induction of Cytochrome P450 3A on the Pharmacokinetics, Safety, and Tolerability of Soticlestat: Two Drug-Drug Interaction Studies in Healthy Volunteers. Drug Metab Dispos. 2024 Feb 14;52(3):516-527.
• Yin W, Ballard TE, Zhu SX, Hsiao S, Chen H, Li Y, Chowdhury SK, Stevenson A, Hui T, Hunt A, Asgharnejad M, Han S. Investigation of the absolute bioavailability, mass balance, metabolism, and excretion of the cholesterol 24-hydroxylase inhibitor soticlestat in healthy volunteers. Br J Clin Pharmacol. 2024 Feb (2):180-187.
• Demarest S, Jeste S, Agarwal N, et al. Efficacy, safety, and tolerability of soticlestat as adjunctive therapy for the treatment of seizures in patients with Dup15q syndrome or CDKL5 deficiency disorder in an open-label signal-finding phase 2 study (ARCADE). Epilepsy & Behavior. 2023;142:109173.
• Yin W, Facius A, Wagner T, et al. Population pharmacokinetics, enzyme occupancy, and 24S- hydroxycholesterol modeling of soticlestat, a novel cholesterol 24-hydroxylase inhibitor, in healthy adults. Clin Transl Sci. 2023;00:1-14.
• Barker-Haliski M, Nishi T, White HS. Soticlestat, a novel cholesterol 24-hydroxylase inhibitor, modifies acute seizure burden and chronic epilepsy-related behavioral deficits following Theiler's virus infection in mice. Neuropharmacology. 2023 Jan 1;222:109310.
• Nishi, T et al. Anticonvulsive properties of soticlestat, a novel cholesterol 24-hydroxylase inhibitor. Epilepsia, 2022;00:1-11.
• Salamone A, et al. Cholesterol 24-hydroxylase is a novel pharmacological target for anti-ictogenic and disease modification effects in epilepsy. Neurobiol Dis. 2022 Oct 15;173:105835.
• Hahn CD, Jiang Y, Villanueva V, Zolnowska M, Arkilo D, Hsiao S, Asgharnejad M, Dlugos D. A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA). Epilepsia. 2022 Oct;63(10):2671-2683.
• Wang S, Chen G, Merlo Pich E, Affinito J, Cwik M, Faessel HM. Pharmacokinetics, pharmacodynamics and safety assessment of multiple doses of soticlestat in healthy volunteers. Br J Clin Pharmacol. 2022 Jun;88(6):2899-2908.
• Koike T, et al. Preclinical characterization of [18F]T-008, a novel PET imaging radioligand for cholesterol 24-hydroxylase. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1148-1156
• Halford, JJ, et al. A phase 1b/2a study of soticlestat as adjunctive therapy in participants with developmental and/or epileptic encephalopathies. Epilepsy Res. 2021;174:106646.
• Wang S, Chen G, Merlo Pich E, Affinito J, Cwik M, Faessel H. Safety, tolerability, pharmacokinetics, pharmacodynamics, bioavailability and food effect of single doses of soticlestat in healthy subjects. Br J Clin Pharmacol. 2021 Nov;87(11):4354-4365.
• Koike T et al. Discovery of Soticlestat, a Potent and Selective Inhibitor for Cholesterol 24-Hydroxylase (CH24H). J Med Chem. 2021 Aug 26;64(16):12228-12244.
• Hawkins, NA et al. Soticlestat, a novel cholesterol 24-hydroxylase inhibitor, reduces seizures and premature death in Dravet Syndrome mice. Epilepsia. 2021;62:2845-2857.
• Nishi, T et al. Soticlestat, a novel cholesterol 24-hydroxylase inhibitor shows a therapeutic potential for neural hyperexcitation in mice. Scientific Reports 2020;10:17081.