NRx Pharmaceuticals has received FDA Investigational New Drug (IND) clearance to initiate the Phase 2/3 MIND1 trial evaluating NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, in adults with treatment-resistant major depressive disorder and suicidality undergoing transcranial magnetic stimulation (TMS).
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
NRx Pharmaceuticals announced that the US Food and Drug Administration has cleared its Investigational New Drug (IND) application to initiate the Phase 2/3 MIND1 clinical trial evaluating NRX-101 in adults with treatment-resistant major depressive disorder (MDD) and suicidality undergoing transcranial magnetic stimulation (TMS).
The placebo-controlled study, titled “A Randomized, Double-Blind, Three-Arm Study of NRX-101 as Adjunctive Therapy to Active or Sham Transcranial Magnetic Stimulation in Adults with Treatment Resistant Major Depressive Disorder (MIND1),” will compare NRX-101 with placebo in patients receiving either robotic-assisted TMS or sham TMS.
NRX-101 is a fixed-dose combination of D-cycloserine, an NMDA receptor modulator, and lurasidone, an atypical antipsychotic. The investigational therapy is being developed for severe depression and suicidal symptoms.
The randomized portion of the trial will enroll 240 participants across a leading US academic teaching hospital and three planned clinical sites operated by HOPE Therapeutics. Additional participants are expected to be enrolled at two US Military Treatment Facilities. The study will be conducted by NRx Defense Systems, a subsidiary of NRx Pharmaceuticals, with study sites to be announced following Institutional Review Board approvals.
According to the protocol summary, the study’s primary endpoint will evaluate changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores, while secondary endpoints will assess suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Prof. Josh Brown, PhD, MD, will serve as principal investigator for the MIND1 trial. Brown previously led predecessor Phase 1 and Phase 2 studies funded by the US Defense Advanced Research Projects Agency. He also serves as Chief Medical Innovation Officer at NRx and Head of TMS Research at McLean Hospital, a Harvard Medical School affiliate.
The company said the newly approved study may receive non-dilutive funding support because of the potential relevance of rapid, non-invasive depression treatment approaches for military personnel and first responders.
Operational leadership for the trial will be overseen by Dr. Dennis K. McBride, President of NRx Defense Systems and former senior executive in the Office of the Secretary of Defense. McBride previously served twice as a Program Manager at the Defense Advanced Research Projects Agency and has managed multiple medical research programs within the US defense sector.
In a company statement, McBride said the FDA clearance supports efforts to address depression and suicide risks among military personnel and first responders. He added that a short-term treatment capable of restoring personnel to duty without conventional antidepressant drugs could represent an important advancement for national defense and public health.
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About the Writer
Vennela Reddy, B Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.