NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) subsidiary NRx Defense Systems secured an initial USD 11.2 million non-dilutive contract from the Defense Advanced Research Projects Agency (DARPA) to support the SPARC-TMS trial, an FDA-cleared study testing NRX-101 alongside rapid robotic transcranial magnetic stimulation (TMS) in treatment-resistant depression.
TMS is a noninvasive treatment that uses a magnetic coil placed against the scalp to deliver repeated pulses to brain regions involved in mood regulation. In SPARC-TMS, a robot-assisted neuronavigation system is used to keep the stimulation coil precisely positioned over the intended brain target while treatment is compressed into a single outpatient day.
The award converts an earlier DARPA selection into a funded prime contract and will support enrollment in SPARC-TMS (NCT07227103), a randomized Phase II/III study expected to enroll up to 400 adults. NRx said the trial will initially involve civilian sites including Harvard Medical School's McLean Hospital and HOPE Therapeutics, with plans to expand into military treatment facilities.
SPARC-TMS is designed to test whether pharmacologically enhancing neuroplasticity can improve the speed and durability of response to an accelerated TMS protocol. Participants receiving active treatment undergo neuronavigated robotic TMS over a single day and receive NRX-101 for five days.
NRX-101 is an investigational oral fixed-dose combination of D-cycloserine and lurasidone. D-cycloserine is an NMDA receptor partial agonist being used to enhance synaptic plasticity, a mechanism thought to contribute to the antidepressant effects of TMS.