Therapy Areas: Central Nervous System
BlackThorn Therapeutics Advances Phase 2 Clinical Development for Selective KOR Antagonist, BTRX-140, in Neuropsychiatric Disorders
27 January 2020 - - US-based biopharmaceutical company BlackThorn Therapeutics, Inc has advanced Phase 2 clinical development for its lead drug candidate, BTRX-335140 (BTRX-140), a selective antagonist for the kappa opioid receptor, the company said.

Dosing has now begun in a Phase 2 proof-of-concept trial for BTRX-140 in a subpopulation of patients with major depressive disorder.

The KOR neuropeptide system is an important mediator of the negative effects of stress-induced alterations on mood, emotional regulation and motivation. KOR antagonism is a novel therapeutic approach, which offers the potential to address key drivers of disability, such as depressed mood, anxiety, anhedonia and cognitive impairment.

These clinical symptoms commonly occur in multiple CNS disorders, but are not adequately addressed by currently available medications for many people seeking therapy.

The Phase 2 proof-of-concept trial is a double-blind, placebo-controlled, randomized trial designed to evaluate the efficacy, safety and tolerability of BTRX-140 in approximately 120 patients with major depressive disorder.

The primary endpoint of the trial is change in Hamilton Rating Scale for Depression (HAM-D) total score in the BTRX-140 treatment group compared to the placebo group following eight weeks of treatment.

BTRX-140 is a potent, selective KOR antagonist being investigated for the treatment of neurobehavioral disorders, including major depressive disorder.

Activation of the KOR system under conditions of stress and disease can contribute to symptoms associated with depressed mood, anhedonia, anxiety and cognitive impairment, which are key drivers of disability in numerous psychiatric and neurological disorders.

BTRX-140 is intended to reduce stress responses and restore dysregulated brain networks underlying these symptom domains, providing a novel therapeutic approach to treating neurobehavioral disorders. BTRX-140 was discovered as part of a research collaboration with The Scripps Research Institute.

BlackThorn Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted medicines for the treatment of central nervous system disorders.