EmbarkNeuro Announces Initiation of Phase 2 Trial of ANC-501, a First-In-Class, V1b Receptor Antagonist for the Personalized Treatment of Depression

VILLANOVA, Pa. and OAKLAND, Calif., Nov. 21, 2022  [PRNewswire] - EmbarkNeuro, a neuroscience-focused biotech company formerly known as Ancora Bio that was founded in 2021 by the venture firm Aditum Bio, today announced that the first patient has been dosed in its Phase 2 trial of ANC-501, a first-in-class vasopressin 1b (V1b) receptor antagonist for the treatment of major depressive disorder (MDD). This 8-week single-arm trial will assess the efficacy of ANC-501 when added to a standard antidepressant therapy in patients with biomarker-confirmed disruption in their stress-response system.

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"Rates of depression and anxiety have risen dramatically since the advent of the COVID-19 pandemic, which has spurred extreme stress due to social isolation and exacerbated health concerns," said Stephen Kanes M.D., Ph.D., Chief Executive Officer of EmbarkNeuro. "As people with a history of adverse childhood experiences, toxic stress or HPA axis disruption have been the hardest hit, it is more important than ever to rethink all aspects of mental health interventions and create targeted treatments with underlying conditions in mind for patients not responsive to standard therapies. We look forward to advancing ANC-501 and providing patients with depression and measurable disruption of their HPA axis with a treatment option. Our new name, EmbarkNeuro, represents our enthusiasm as we embark on the exploration of new pathways for the treatment of brain health disorders."

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The multi-center, open-label Phase 2 clinical trial is designed to evaluate the safety, tolerability, and efficacy of orally administered ANC-501 50mg over 8 weeks. The trial will enroll individuals aged 18-65 who are currently depressed and for whom standard treatments have not been effective. Patients with moderate to severe MDD who have confirmed baseline cortisol level elevations are eligible to participate. The primary efficacy endpoint is change from baseline at the end of 8 weeks of treatment using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Participants will be followed for safety assessments for an additional 8 weeks following completion of dosing. For more information about the trial, please visit www.clinicaltrials.gov (identifier NCT05439603).

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A double-blind placebo-controlled trial of ANC-501 in patients with depression is planned for 2023 based on the outcome of this initial Phase 2 trial. ANC-501 is an investigational compound and not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

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About Major Depressive Disorder (MDD)

Major depressive disorder (MDD) is a common condition affecting over 20 million U.S. residents annually causing social, occupational, and educational impairment, along with depressed mood or loss of interest or pleasure in daily activities. The hypothalamic-pituitary-adrenal (HPA) axis plays a critical role in managing the body's response and adaption to stress. The peptide hormone vasopressin acting through the vasopressin 1b (V1b) receptors is a key regulator of the body's stress response.

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About EmbarkNeuro

EmbarkNeuro, formerly known as Ancora Bio, is focused on bringing important new personalized treatments to patients with mental health disorders. Rates of major depression are rapidly rising, much of this attributable to the dramatic increase in stress brought on by the COVID-19 pandemic. The company is identifying depressed individuals with a potential biomarker linked to the stress response system (elevated cortisol) and developing ANC-501 as a new treatment specifically for these patients. For more information about EmbarkNeuro, please visit www.embarkneuro.com.

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About Aditum Bio

Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a huge impact. Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology’s, and spins-out individual companies dedicated to bringing each candidate through Phase II clinical trials. Aditum Bio uses data, software and technology to help bring innovative medicines through the clinical trial phase more quickly and with lower costs than traditional pharmaceutical companies.