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  • ||||||||||  ANC-501 / Aditum Bio
    Enrollment closed, Trial completion date, Trial primary completion date:  ANC-501 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) -  Jun 23, 2023   
    P2,  N=20, Active, not recruiting, 
    The effect sizes for improvements in depression were d=1.8 for in person ratings and d=1.3 for EMA. Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Nov 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
  • ||||||||||  ANC-501 / Aditum Bio
    ANC-501: A Novel V1b Receptor Antagonist for the Treatment of MDD (Salon 4) -  May 9, 2023 - Abstract #ASCP2023ASCP_394;    
    ANC-501 (formerly TS-121) is an investigational new drug with antagonistic activity of the vasopressin receptor 1b (V1b receptor), which plays a role in the modulation of stress and mood...Preliminary evidence in an ongoing open-label trial suggests that ANC-501 shows evidence of activity on both MADRS and HAM-A scales in patients with Moderate to Severe MDD along with elevations in Cortisol. If this preliminary evidence is confirmed, ANC-501 would be the first MDD treatment specifically developed for patients with measurable disruptions in the stress response axis.
  • ||||||||||  ANC-501 / Aditum Bio
    ANC-501, A Novel V1B Receptor Antagonist: Association of MDD Response With MADRS Subscales (Grand Saguaro) -  Oct 31, 2022 - Abstract #ACNP2022ACNP_473;    
    While this exploratory analysis is limited by a small sample size, these data, if replicated in subsequent studies, may characterize a group of MDD patients whose symptoms are uniquely responsive to V1b antagonism, supporting a personalized, biomarker-driven approach to the treatment of MDD. A phase 2 study of ANC-501 in MDD patients with elevated cortisol is ongoing.
  • ||||||||||  ANC-501 / Aditum Bio
    Enrollment open:  ANC-501 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) -  Sep 10, 2022   
    P2,  N=20, Recruiting, 
    A phase 2 study of ANC-501 in MDD patients with elevated cortisol is ongoing. Not yet recruiting --> Recruiting
  • ||||||||||  ANC-501 / Aditum Bio
    ANC-501: A Novel V1b Receptor Antagonist for Major Depressive Disorder (Palomino Ballroom 4-10) -  May 6, 2022 - Abstract #ASCP2022ASCP_207;    
    ANC-501 (formerly TS-121) is an investigational new drug with antagonistic activity of the vasopressin receptor 1b (V1b receptor), which plays a role in the modulation of stress and mood...ANC-501 is being developed as an adjunctive therapy for MDD patients who have responded inadequately to standard anti-depressants and clear disruptions in their HPA axis. A phase 2 study of ANC-501 will initiate in 2022.
  • ||||||||||  TS-121 / Aditum Bio
    Journal:  Imaging pituitary vasopressin 1B receptor in humans with the novel PET radiotracer C-TASP699. (Pubmed Central) -  Apr 5, 2022   
    There were no adverse events resulting in discontinuation from the study. C-TASP699 was shown to display appropriate kinetics in human with substantial specific binding and good reproducibility of V Therefore, this tracer is suitable for measurement of the VR in human pituitary and VR occupancy of TS-121, a novel VR antagonist.
  • ||||||||||  TS-121 / Aditum Bio
    Journal:  Vasopressin V1B Receptor Antagonists as Potential Antidepressants. (Pubmed Central) -  Feb 1, 2022   
    Importantly, TS-121 showed a clearer efficacy for patients with higher basal cortisol levels than for those with lower basal cortisol levels, which was consistent with the hypothesis that V1B receptor antagonists may be more effective for patients with HPA axis hyperactivity. Therefore, V1B receptor antagonists are promising approaches for the treatment of depression involving HPA axis impairment such as depression.
  • ||||||||||  TS-121 / Aditum Bio
    Preclinical, Journal:  Prediction of a clinically effective dose of THY1773, a novel V receptor antagonist, based on preclinical data. (Pubmed Central) -  Nov 21, 2021   
    Retrospective analysis of the prediction accuracy suggested that the prediction methods considering plasma protein binding, and avoiding to apply unknown scaling factors obtained in animals to humans, would lead to better prediction. Selecting mechanism-based methods with reasonable assumptions would be critical for the successful prediction of a clinically effective dose in the preclinical stage of drug development.
  • ||||||||||  TS-121 / Taisho
    [VIRTUAL] Discovery of THY1773, a novel V1b receptor antagonist for the potential treatment of depression (On Demand Poster) -  Aug 20, 2020 - Abstract #ACSFall2020ACS-Fall_5443;    
    These resulted in the discovery of the potent and selective V1b receptor antagonist THY1773, which showed a favorable pharmacokinetic profile in rats and dogs and showed antidepressant-like effects in animal models in which HPA axis function is impaired. THY1773, the active ingredient of TS-121, has shown promise as a drug candidate for augmentation of antidepressant therapy based on the results of a phase 2 clinical trial in patients with inadequate antidepressant response.