BlackThorn Therapeutics has commenced dosing of BTRX-335140 (BTRX-140) in a proof-of-concept Phase II clinical trial involving patients with major depressive disorder.

A subpopulation of trial participants is being dosed with the drug candidate, which is a selective kappa opioid receptor (KOR) antagonist.

Discovered in collaboration with The Scripps Research Institute, BTRX-140 is being developed to treat neurobehavioral conditions such as major depressive disorder.

KOR system activation under stress and disease is known to cause symptoms of depressed mood, anxiety, anhedonia and cognitive impairment. These symptoms are linked to disability in different psychiatric and neurological diseases.

BTRX-140 is designed to decrease stress responses and restore dysregulated brain networks responsible for the symptoms. This mechanism is expected to offer a new treatment approach for neurobehavioral disorders.

BlackThorn Therapeutics president and CEO Bill Martin said: “Independent clinical research has shown that blocking KOR modulates key brain circuits and reduces symptoms in patients with mood and anxiety disorders.

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“Using our precision approach, we have gained novel insights about the patients most likely to benefit from KOR antagonist therapy.”

The double-blind, placebo-controlled, randomised Phase II trial will assess the safety, efficacy and tolerability of the drug candidate in about 120 major depressive disorder patients.

The primary endpoint is the change in the Hamilton Rating Scale for Depression (HAM-D) total score after eight weeks of therapy. The trial will compare the HAM-D total score between BTRX-140 and placebo groups.

BlackThorn Therapeutics chief medical officer Jane Tiller said: “By targeting the KOR system, BTRX-140 has the potential to address clinical symptoms shared across multiple disorders.

“The BTRX-140 Phase II development programme is supported by positive Phase I results, which confirmed that BTRX-140 engages KORs in the brain at levels that are projected to be effective in treating symptoms relevant to depression and other CNS disorders.”

In this study, the company is applying data-driven insights to validate BTRX-140’s mechanism.