EmbarkNeuro Announces Initiation of Phase 2 Trial of ANC-501 for the Personalized Treatment of Depression (MDD)

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.

“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.”

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.

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.