EmbarkNeuro has dosed the first participant in the Phase II trial of ANC-501 to treat major depressive disorder (MDD).

The multi-centre, single-arm, open-label Phase II trial has been designed for assessing the efficacy, safety, and tolerability of 50mg of orally given ANC-501 for eight weeks.

In the study, ANC-501’s efficacy will be assessed when it is added to a standard antidepressant therapy for patients who have biomarker-confirmed disruptions in their stress response system.

People aged 18 to 65 years who are currently depressed and whose standard treatments have not been effective will be enrolled in the study.

Moderate to severe MDD patients, with confirmed baseline cortisol level elevations, are eligible to take part in the trial.

The change from baseline calculated using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at the end of eight weeks of treatment will be the study’s primary efficacy endpoint.

The participants will also be followed for an additional eight weeks for safety evaluations after completion of dosing. 

EmbarkNeuro CEO Stephen Kanes said: “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.

“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.”

ANC-501 is an investigational first-in-class vasopressin 1b (V1b) receptor antagonist.