Apimostinel

Gate Neurosciences Announces Positive Topline Human EEG Biomarker Results Demonstrating Dose-Dependent Target Activation in Phase 1 Study of Apimostinel

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Tuesday, November 7, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Pharmacology, Trial of the century, Phase II, MDD, Biomarker, IV, CSF, DSM-IV codes, Gate, Zelquistinel, Neuroscience, Medicine, Safety, Quantitative electroencephalography, NMDA, Patient, POC, Pharmaceutical industry, Vaccine, Apimostinel

Gate Neurosciences , a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, today announced positive topline qEEG biomarker and safety results from its Phase 1 multiple ascending dose study of apimostinel in healthy volunteers.

Key Points: 
  • Gate Neurosciences , a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, today announced positive topline qEEG biomarker and safety results from its Phase 1 multiple ascending dose study of apimostinel in healthy volunteers.
  • Results demonstrated a dose-dependent increase in qEEG pharmacodynamic biomarkers of NMDA receptor target activation from baseline, compared with subjects who received placebo.
  • Apimostinel was also generally well-tolerated with no ketamine-like dissociative side effects, highlighting its novel mechanistic approach of enhancing synaptic function.
  • Gate plans to initiate a Phase 2 study of zelquistinel to confirm efficacy in MDD in Q1 2024.

Gate Neurosciences Doses First Subject in a Translational EEG Biomarker Study of Apimostinel, a Rapid-Acting Treatment for Acute Depressive Disorders

Retrieved on: 
Tuesday, November 29, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Modulation, Mental health, ED, Gate, NMDAR, University, NIMH, United States Public Health Service, Physician, Patient, Suicidal ideation, NMDA, Dean, EEG, CNS, Neuropsychiatry, Depression, Neuroscience, Precision medicine, ERP, Suicide, Wilfrid Sellars, MDD, Pharmaceutical industry, Apimostinel

Gate Neurosciences is developing apimostinel to address urgent patient and evolving practice needs for a safe, rapid-acting, in-office treatment of acute depressive disorders such as postpartum and episodic depression, and depression with suicidality.

Key Points: 
  • Gate Neurosciences is developing apimostinel to address urgent patient and evolving practice needs for a safe, rapid-acting, in-office treatment of acute depressive disorders such as postpartum and episodic depression, and depression with suicidality.
  • Apimostinel previously demonstrated proof-of-concept in a Phase 2a MDD study and the ongoing biomarker study aims to further enhance the understanding of dose dynamics using various electroencephalogram (EEG) measures after single and multiple ascending doses in 40 healthy subjects.
  • Gate Neurosciences plans to use results from the EEG biomarker study to further de-risk dose selection in a confirmatory Phase 2b efficacy study of apimostinel planned for initiation in mid-2023.
  • Gate Neurosciences is a precision medicine biotechnology company focused on advancing next-generation CNS treatments that address growing needs in mental health.

Gate Neurosciences Publishes Data Highlighting Novel Mechanism of Lead Rapid-Acting Oral Antidepressant and Provides Business Update

Retrieved on: 
Thursday, September 29, 2022
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Molecule, Safety, Hospital, Institutional review board, Patient, Pharmacology, Investigational New Drug, IGF2R, Research, Northwestern University, Rockefeller University, Physical, NMDA, Division, Annual general meeting, Sleep, The International Journal of Neuropsychopharmacology, Northwestern, Hippocampus, Depression, MADRS, FDA, Literature, Lists of diseases, IND, GABA, Mental health, CEO, Board of directors, Method, Board, Eli Lilly, Electroencephalography, Plasma, Half-life, Precision medicine, Canadian International Council, Psychiatry, Biomarker, Publication, Massachusetts General Hospital, Therapy, Interneuron, Ataxia, Prefrontal cortex, Authorization, CNS, EEG, AbbVie, NMDAR, Depressive, Pharmaceutical industry, Apimostinel, MDD, Rapastinel

Publication highlights robust preclinical profile and novel mechanism for lead Phase 2 clinical program, Zelquistinel

Key Points: 
  • Publication highlights robust preclinical profile and novel mechanism for lead Phase 2 clinical program, Zelquistinel
    The peer-reviewed manuscript spotlights Zelquistinels novel mechanism and pharmacology by which it elicits rapid and long-lasting antidepressant effects.
  • These data highlight Zelquistinels novel, potent, and highly differentiated mechanism of action with potential for a significantly improved safety profile compared to other NMDAR-targeted antidepressants in development for depressive disorders.
  • Published in several peer-reviewed journals highlighting novel NMDAR mechanism and antidepressant activity of lead programs.
  • Gate Neurosciences lead programs are highly differentiated from other NMDAR-targeted antidepressants by acting through positive modulation instead of antagonism.

Gate Neurosciences Emerges from Stealth with a Portfolio of Next-Generation Therapies for Central Nervous System Diseases

Retrieved on: 
Tuesday, August 23, 2022
Biotechnology, Pharmaceutical, Health, Mental Health, AbbVie, University, Wilfrid Sellars, Central nervous system disease, Central nervous system, Precision medicine, Outline of health sciences, Lists of diseases, Senior, Dean, Ketamine, Therapy, Allergan, Mental health, Biomarker, MDD, NMDAR, Acquisition, Drug development, CNS, NMDA, Patient, Pharmaceutical industry, Gate, Apimostinel, Rapastinel

Gate Neurosciences today announced it has officially launched to develop its next-generation therapeutics addressing synaptic dysfunction in patients suffering from central nervous system (CNS) disorders.

Key Points: 
  • Gate Neurosciences today announced it has officially launched to develop its next-generation therapeutics addressing synaptic dysfunction in patients suffering from central nervous system (CNS) disorders.
  • The company is focused on developing novel mechanisms that address synaptic dysfunction underlying neuropsychiatric and cognitive disorders, including major depressive disorder (MDD).
  • Gate will provide a strategic business update in the coming weeks that will provide additional information on its diverse development portfolio and major recent and upcoming milestones.
  • The company is developing a portfolio of novel mechanisms of action that enhance synaptic function to address neuropsychiatric and neurocognitive diseases, including major depressive disorder (MDD).