BlackThorn begins phase 2a study of BTRX-246040 for major depression

BlackThorn Therapeutics recently announced enrollment of the first participant in a phase 2a study of BTRX-246040 for major depressive disorder in adults.

“This phase 2a study includes emerging technologies that can identify patient subpopulations that can be specifically targeted beyond traditional clinical measures,” Annette Madrid, MD, chief medical officer of BlackThorn, said in a press release. “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.”

To evaluate efficacy, safety and tolerability of once daily BTRX-246040 among adults with major depressive disorder (MDD) with or without anhedonia, researchers plan to conduct a randomized, double-blind, placebo-controlled, multicenter, phase 2a study. The primary study endpoint is treatment effect on depression symptoms in MDD, measured by the Montgomery-Asberg Depression Rating Scale.

The study will also assess efficacy of BTRX-246040 with Mindstrong Health’s smartphone technology, Canary Speech’s software and P1vital Products’ Facial Expression Recognition Task.

Researchers will collect data from quantitative behavioral assessments using proprietary tests developed at Emory University and Harvard University.

“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,” Greg Vontz, CEO of BlackThorn, said in the release. “We plan to initiate additional trials of BTRX-246040 investigating the role of nociceptin antagonism in other patient populations. 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.”