NRx Defense Systems awarded $11.2 million DARPA contract for SPARC-TMS trial

NRx Defense Systems, a subsidiary of NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), has been awarded an initial contract valued at $11,177,757.27 by the Defense Advanced Research Projects Agency. The funding supports the Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) trial, which is approved by the US Food and Drug Administration and will begin enrolling patients. The trial aims to evaluate whether a single day of robotic neuronavigated Transcranial Magnetic Stimulation (TMS), augmented by the investigational drug NRX-101, can effectively treat major depressive disorder. DARPA states that if the program succeeds, it will fundamentally change the standard of care for treatment-resistant depression, addressing military concerns that current treatments are not deployable in operational settings. The SPARC-TMS protocol is based on a recently completed randomized-controlled trial funded by DARPA. That prior study published real-world findings showing a 91% treatment response and 69% remission rate at three months post-treatment using traditional TMS combined with D-cycloserine, an active ingredient of NRX-101. If these results are replicated in the new SPARC-TMS trial, the study has the potential to serve as an FDA registration study for the approval of NRX-101 in conjunction with TMS for people with treatment-resistant depression. The trial will be conducted at Harvard Medical School’s McLean Hospital, Arizona State University, and HOPE Therapeutics, with plans to expand to leading military hospitals. The treatment involves no psychedelic experience, intense supervision, or anesthesia, and utilizes a robotic targeting system with precision of 1mm or less. NRX-101 combines d-cycloserine and lurasidone to enhance NMDA receptor function. The company estimates the burden of illness for treatment-resistant depression at $44 billion among 8.9 million American adults. The project is led by Prof. Joshua Brown, Chief Medical Innovation Officer, and Dr. Dennis McBride, a former DARPA program manager and retired US Navy Captain. NRx Defense Systems is partnered with HOPE Therapeutics, Harvard Medical School’s McLean Hospital, Arizona State University, Zeta Surgical Systems, and Neurocare of America.