Villanova, PA and Oakland, CA, November 21, 2022 [PR NEWSWIRE] – 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 stressresponse
“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. For more
information about the trial, please visit www.clinicaltrials.gov (identifier NCT05439603).
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.
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.
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 firstname.lastname@example.org.
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