WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) received U.S. Food and Drug Administration clearance to begin a late-stage clinical trial evaluating whether its investigational NRX-101 therapy can improve outcomes for patients with treatment-resistant depression undergoing transcranial magnetic stimulation, potentially expanding noninvasive treatment options for military personnel and first responders.
The placebo-controlled Phase 2/3 trial, known as MIND1, will study NRX-101 — a fixed-dose combination of D-cycloserine and lurasidone — in adults with major depressive disorder and suicidality who are treated with either robotic-assisted transcranial magnetic stimulation, or TMS, or sham TMS, the company announced.
NRx said the randomized portion of the study is expected to enroll 240 participants at a U.S. academic teaching hospital and three planned clinical sites operated by HOPE Therapeutics. Additional participants are expected to be recruited through two U.S. military treatment facilities pending institutional review board approvals.
The trial reflects growing interest in combining pharmacological therapies with TMS, a noninvasive brain stimulation technique increasingly used for patients whose depression has not responded to standard antidepressants.
NRx cited preliminary research suggesting D-cycloserine may enhance the effects of TMS treatment. If successful, the company believes the approach could help address operational readiness concerns tied to depression and suicide among military personnel and first responders.
The company stated it is seeking non-dilutive funding to support enrollment of as many as 400 patients, citing potential national security and workforce implications tied to faster-acting depression treatments.
The study will be overseen by Dr. Josh Brown, a Harvard McLean Hospital psychiatrist and head of TMS research who previously led related Defense Advanced Research Projects Agency-backed studies. Brown also serves as NRx’s chief medical innovation officer.
Operational leadership for the program will come from NRx Defense Systems President Dennis McBride, a retired Navy Medical Service Corps captain and former Defense Advanced Research Projects Agency program manager.
“A short-term treatment that has the potential to restore vital personnel to duty without disqualifying antidepressant drugs would be a major advance,” McBride said in a statement.
NRx did not provide a timeline for first patient enrollment or anticipated data readouts.
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