SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--BlackThorn Therapeutics, a clinical-stage biopharmaceutical company discovering and developing targeted treatments for neurobehavioral disorders, today announced enrollment of the first patient in a Phase 2a study of BTRX-246040 in adults with major depressive disorder (MDD). BTRX-246040, BlackThorn’s lead program, is a first-in-class antagonist of the nociceptin receptor (NOPR), a target linked to multiple neurobehavioral disorders.
“This Phase 2a study includes emerging technologies that can identify patient subpopulations that can be specifically targeted beyond traditional clinical measures,” said Annette Madrid, M.D., chief medical officer of BlackThorn. “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 initiation of this Phase 2a study in patients with MDD marks an important milestone for BlackThorn as we initiate our first clinical trial integrating novel technologies to provide deeper insights into patient characteristics and therapeutic responses. We plan to initiate additional trials of BTRX-246040 investigating the role of nociceptin antagonism in other patient populations,” said Greg Vontz, chief executive officer of BlackThorn. “We look forward to the results of our Phase 2a studies and their readouts, which we believe will provide new insights to guide the design of later-stage clinical trials of BTRX-246040.”
Phase 2a Study Design
The randomized, double-blind, placebo-controlled, multicenter Phase 2a study is evaluating the efficacy, safety and tolerability of BTRX-246040 administered once daily for eight weeks in adults with MDD (ages 18 to 65 years) with or without anhedonia (inability to feel pleasure). The primary objective of the study is to evaluate the effects of BTRX-246040 on symptoms of depression in adults with MDD as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The study also will evaluate the efficacy of BTRX-246040 with the following quantitative, objective tools and behavioral assessments:
- Mindstrong Health’s patented smartphone technology, which passively and continuously collects cognitive-behavioral biomarkers. Mindstrong demonstrated in three multi-year longitudinal studies that its biomarkers predict serial neuropsychological test scores and detect the real-time effect of mood and sleep disorders on cognitive function.
- Canary Speech’s software, which will be used to collect vocal samples that can be analyzed for markers of mood, affect and cognitive function. Canary Speech uses advanced speech and language technology to analyze vocal data from a library of proprietary speech and language markers for a range of human conditions.
- P1vital Products’ Facial Expression Recognition Task (FERT), which provides an early signal of changes in emotional bias that are indicative of later improvements in mood.
Additionally, BlackThorn will collect data from quantitative behavioral assessments using its proprietary tests developed by researchers at both Emory University and Harvard University.
New Treatment Options Needed for MDD
Major depressive disorder (MDD) is one of the most common mood disorders and causes considerable suffering, functional impairment and increased mortality.1 By 2020, depressive disorders are projected to be the second highest cause of morbidity in the world.2 MDD is often chronic and recurrent with a sizable relapse rate.3 Individuals with MDD often require multiple trials with different antidepressants to achieve treatment effects, and a substantial number of patients do not experience adequate symptom relief.4 There is a need for new antidepressants that are developed in a targeted fashion based on a data-driven understanding of patient subtypes.
About BlackThorn Therapeutics, Inc.
BlackThorn Therapeutics is a clinical-stage biopharmaceutical company dedicated to transforming the lives of people with neurobehavioral disorders through the discovery and development of novel, targeted treatments. BlackThorn has a robust pipeline of first- and best-in-class treatments. The company approaches drug discovery and development by linking brain physiology to behavior. Through BlackThorn’s network of collaborations with leading academic investigators and technology alliances, the company is developing and deploying a set of technologies that will enable focused, rapid, resource-efficient translational studies for drug development. The company is headquartered in South San Francisco, Calif. For more information, please visit http://www.blackthornrx.com/.
1 Kessler 2003, Cuijpers 2013.
2 Murray 1996.
3 Warden 2007.
4 Rush 2006.