Phase 2 trial initiated for depression treatment targeting specific biomarker

EmbarkNeuro, a neuroscience biotech company formerly known as Ancora Bio, announced its phase 2 trial is under way for ANC-501, a first-in-class vasopressin 1b receptor antagonist for the treatment of major depressive disorder.

The trial, an 8-week single-arm study, 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,” EmbarkNeuro CEO Stephen Kanes, MD, PhD, said in a release from the company.

The multicenter, open-label phase 2 clinical trial is designed to assess the safety, tolerability and efficacy of the orally administered ANC-501 50 mg dose over 8 weeks. The trial will enroll those aged 18 to 65 years who are currently depressed and for whom standard treatments have not worked.

“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,” Kanes said in the release. “We look forward to advancing ANC-501 and providing patients with depression and measurable disruption of their HPA axis with a treatment option.”