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Biomarker-Guided Depression Drug Trial Underway

Sad, depressed

(Daniel Reche, Pixabay)

22 Nov. 2022. The first participant in a clinical trial received an experimental drug to treat patients with depression that express high levels of a stress-related protein. The study is conducted by the start-up biotechnology company EmbarkNeuro in Oakland, California and Villanova, Pennsylvania, developer of the drug code-named ANC-501.

EmbarkNeuro, founded last year as Ancora Bio, is a developer of treatments for mental health disorders traced to underlying protein imbalances in the brain associated with the conditions. ANC-501 is the company’s lead product for treating people with major depressive disorder. Depression is a widespread mood condition characterized by continual feelings of sadness and loss of interest. When these feeling persist for long periods of time, the condition becomes a serious debilitating disease called clinical depression or major depressive disorder that requires treatment. National Library of Medicine says some 19 million teens and adults in the U.S. have depression.

EmbarkNeuro says ANC-501 is an oral drug designed to address an underlying factor in many people with major depressive disorder, high levels of the hormone cortisol produced by adrenal gland. High cortisol levels are a result of stress, which in most people return to normal when the stress-inducing conditions abate. In people with chronic stress, however, elevated cortisol levels can disrupt many bodily processes, including those in the brain, leading to disorders such as anxiety and depression.

Testing ANC-501 plus current treatment

ANC-501, says EmbarkNeuro, is designed to reduce cortisol levels, by blocking triggering proteins upstream from the adrenal gland. Those proteins are vasopressin 1b or V1b receptors in the pituitary gland. V1b receptors are connected to cortisol levels through an intermediary, adrenocorticotropic hormone or ACTH, also produced in the pituitary gland. The company says its preclinical tests indicate limiting V1B receptors with ANC-501 reduces depression-like behaviors in lab animals, including those with damage to a region of the brain called the hypothalamic-pituitary-adrenal or HPA axis, from extended high cortisol levels, making them resistant to some therapies.

“Rates of depression and anxiety have risen dramatically since the advent of the Covid-19 pandemic,” says EmbarkNeuro CEO Stephen Kanes in a company statement, “which has spurred extreme stress due to social isolation and exacerbated health concerns. 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.”

The mid-stage clinical trial is enrolling 20 adults from Florida and New York diagnosed with major depressive disorder, not responding to previous therapies, and show elevated cortisol levels in urine tests. Participants continue to take their current medications, but are also given ANC-501 taken as 10 milligram capsules, five times a day. The study team is tracking participants’ scores on a standard Montgomery-Asberg Depression Rating Scale for eight weeks, comparing scores during and after the trial to those taken at the start of the study. In addition, the team is looking for any adverse reactions to ANC-501 for 16 weeks.

The trial has no placebo-control or comparison group. Based on the results of this trial, EmbarkNeuro is planning a placebo-controlled clinical study for next year.

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