ANC-501 / Taisho, Aditum Bio - LARVOL DELTA

ANC-501 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Using Active and Passive Digital Phenotyping to Augment Efficacy Assessments in an Early-Stage Drug Development Program (ASCP 2024) - ". 2024 ASCP Annual Meeting A total of 658 EMA surveys were collected as well as 184 patient-days of actigraphy. In person and EMA based ratings of depression improved to day 56, all p<.02. The effect sizes for improvements in depression were d=1.8 for in person ratings and d=1.3 for EMA."

Clinical • Late-breaking abstract • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ANC-501-A Novel V1b Receptor Antagonist: Results of a Personalized Phase 2 Trial in MDD (ACNP 2023) - "In the current study of a proactively selected population of MDD with patients with cortisol elevations, ANC-501 50mg PO QD for 8-weeks adjunctively administered along with standard antidepressant treatment was well tolerated and demonstrated a strong signal for antidepressant activity. This study supports continued development of ANC-501 as an adjunctive treatment in MDD specifically for patients with HPA axis disruptions."

P2 data • CNS Disorders • Depression • Mood Disorders • Psychiatry • Suicidal Ideation

Using Active and Passive Digital Phenotyping to Augment Efficacy Assessments in an Early-Stage Drug Development Program (ACNP 2023) - "Even in a small, unblinded trial, passive and active digital phenotyping assessments converge with and predict clinical ratings. Most importantly, digital phenotyping content that is not an obvious element of an efficacy assessment (productive activities; step counts) correlates with concurrent clinical ratings and predicts later clinical changes. In this study, adherence was high and digital phenotyping data anticipated later clinical ratings, suggesting that these clinical ratings are truly sampling the stream of behavior that leads up to the dispersed ratings ."

Clinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ANC-501 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Nov 2023 | Trial primary completion date: Mar 2023 ➔ Sep 2023

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ANC-501: A Novel V1b Receptor Antagonist for the Treatment of MDD (ASCP 2023) - "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."

CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Taisho develops and transfers rights to treatment candidates for depression [Google translation] (Medical News) - Japan's Taisho Pharmaceutical announced...that it would provide the exclusive development, manufacture and distribution rights of a candidate substance for treatment of depression to Aditum Bio...Taisho has partnered with Additum to promote the development of treatment candidate substances, and has agreed to receive a lump-sum contract, a success fee based on development progress and sales, and royalties. The therapeutic candidate provided by Taisho is 'TS-121', which inhibits the action of a protein fragment (neuropeptide) that plays an important role in the stress response, and is a selective vasopressin V1b receptor antagonist."

Licensing / partnership • CNS Disorders • Depression

ANC-501, A Novel V1B Receptor Antagonist: Association of MDD Response With MADRS Subscales (ACNP 2022) - "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... In this trial, post-hoc analysis of the MDD patients with elevated cortisol and who responded to V1b antagonism were characterized by a specific sub-group of baseline symptoms broadly consistent with Melancholic depression, a subtype of depression previously shown to have HPA axis disruption. 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."

CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

ANC-501 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Ancora Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ANC-501 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Ancora Bio, Inc.

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ANC-501: A Novel V1b Receptor Antagonist for Major Depressive Disorder - "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."

Late-breaking abstract • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Imaging pituitary vasopressin 1B receptor in humans with the novel PET radiotracer C-TASP699. (PubMed, J Nucl Med) - "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."

Journal • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry

[VIRTUAL] Discovery of THY1773, a novel V1b receptor antagonist for the potential treatment of depression (ACS-Fall 2020) - "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."

CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and safety of TS-121, a novel vasopressin V receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study. (PubMed, J Psychiatr Res) - "Higher baseline urinary and hair cortisol levels were associated with a greater separation between TS-121 groups and the placebo group in the primary endpoint. These findings, combined with favorable safety and tolerability, warrant further investigation of TS-121 in an adequately powered study in patients with MDD."

Clinical • Journal • CNS Disorders • Depression • Mood Disorders

Clinical and demographic characteristics of relapsing-remitting multiple sclerosis in Kazakhstan (ECTRIMS 2018) - "...The degree of disability according to EDSS within 0-1 points have-25 patients (9.8%), 1.5-4.5 points-121 patients (47.3%), 5.0-6.5 points- 92 (35,9%), 7,0-9,5 score-18 patients (7.0%). among women with RMS, women prevail, in the ratio of men and women-1:2.5, as well as persons of the European population 1:4,8, the disease in the debut affects people older than 20-30 years, the manifestation of the disease is more often characterized by the defeat of the pyramidal function, with a high degree of disability, corresponding to the 2nd and 3rd group of disability. Individuals with NOSD were found exclusively in individuals of the Asian population, female, with loss of visual function."

Clinical • Biosimilar • CNS Disorders • Complement-mediated Rare Disorders • Immunology • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ophthalmology • Rare Diseases

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TS-121, a Novel Vasopressin V1b Receptor Antagonist, as an Adjunctive Treatment for Patients with Major Depressive Disorder (ACNP 2019) - "Overall, greater improvement in depression symptoms were observed for subjects treated with TS-121 compared to those treated with placebo, and the trend was more apparent in subjects with higher urinary and hair cortisol levels. These findings combined with good tolerability warrant further investigation of TS-121 in patients with MDD."

Clinical