BlackThorn starts enrolment in Phase IIa trial for MDD drug
US-based biopharmaceutical firm BlackThorn Therapeutics has started patient enrolment in a Phase IIa clinical trial of BTRX-246040 to treat adults with major depressive disorder (MDD).
BTRX-246040 is being developed as an antagonist for the nociceptin receptor (NOPR) associated with various neurobehavioural disorders.
The randomised, double-blind, placebo-controlled, multi-centre Phase IIa will enrol patients aged 18-65 with or without anhedonia.
Designed to assess the efficacy, safety and tolerability of once-daily BTRX-246040 over a period of eight weeks, the trial will utilise various quantitative, objective tools and behavioural assessments.
BlackThorn chief medical officer Annette Madrid said: “This Phase IIa study includes emerging technologies that can identify patient subpopulations that can be specifically targeted beyond traditional clinical measures.
“Through the strategic use of these technologies, we aim to gain novel, meaningful insights to help manage the considerable patient diversity seen in neurobehavioral disorders.”
The trial’s quantitative behavioural assessment data will be collected using the firm’s tests developed by Emory and Harvard Universities’ researchers, while the cognitive-behavioural biomarkers will be collected with a smartphone technology called Mindstrong Health.
The ability of Mindstrong’s biomarkers to predict serial neuropsychological test scores, and the effect of mood and sleep disorders on cognitive function was validated in three multi-year longitudinal studies.
Vocal samples for markers of mood, affect and cognitive function will be collected using Canary Speech that employs speech and language technology to evaluate the vocal data.
During the trial, early signal of changes in emotional bias considered as indicators for later improvements in mood is measured using P1vital Products' facial expression recognition task (FERT).