NeuroRx Initiates NRX-101 Study for Suicidal Bipolar Depression

NeuroRx has initiated a pivotal Phase 2b/3 study for NRX-101 for the treatment of patients with Severe Bipolar Depression and Acute Suicidal Ideation and Behavior (ASIB). NRX-101 has been granted Breakthrough Therapy Designation and Fast Track Designation by the US Food and Drug Administration (FDA). NRX-101 is designed to address bipolar depression with suicidal ideation, an indication for which there is no currently approved drug and for which the only FDA-approved treatment remains electroconvulsive therapy (ECT).

The pivotal trial design is based on a Special Protocol Agreement (SPA) with the FDA and is similar to the design of the Company's Phase 2 study, STABIL-B, which demonstrated a statistically significant and clinically meaningful difference in suicidal bipolar depression in a head-to-head study between NRX-101 and lurasidone, the standard of care medication. The Phase 2b/3 study will enroll approximately 140 patients with Severe Bipolar Depression and ASIB who are stabilized following a single IV infusion of ketamine. Study participants will be randomized to receive either NRX-101 or lurasidone for six weeks. The primary endpoint is the reduction of depression as measured by the industry-standard MADRS-10 scale. Suicidality and relapse will be measured and monitored throughout the study as secondary endpoints.

"We are delighted to initiate this study of patients suffering from Severe Bipolar Depression and ASIB at JPS Health Network (JPS) in Fort Worth, Texas. NeuroRx is addressing a life-threatening condition that kills 25,000 Americans each year and for which the only currently approved therapy is ECT, with its known complications. This study is the first to test a potentially life-saving alternative for patients with an unmet medical need. The NeuroRx study gives JPS Behavioral Health an opportunity to address an important area of clinical need," said Cindy Claassen, PhD, JPS Behavioral Health Director of Research and Education. "Patients who have bipolar depression and who are suicidal are among the highest risk patients we treat at JPS. In patients with unstable mood, suicidal crises can erupt suddenly and with very little warning—at times leading rapidly to dangerous behaviors. Among existing treatments there is frequently a risk of actually increasing the risk of suicidal behaviors instead of lowering risk."

Bipolar disorder, which affects 5.7 million Americans, is characterized by significant changes in mood, from mania or hypomania to depression, often quite severe. The depressive phase can trigger suicidal thoughts and behaviors. Currently the only FDA-approved treatment for suicidal bipolar depression is electroconvulsive therapy (ECT), which is shown to increase levels of Glx in the brain. Despite its effectiveness, ECT has a myriad of well-known adverse side effects, including confusion and memory loss. Unfortunately, most currently-approved antidepressants bear an FDA- mandated warning label identifying the potential to increase the risk of suicide.

Each day, approximately 100 Americans, and more than 2,100 people worldwide, end their lives by suicide, according to the American Foundation for Suicide Prevention (AFSP) and the World Health Organization (WHO). Individuals who suffer from bipolar depression are at far greater risk of suicide than those with major depressive disorder and are believed to represent between 25% and 40% of the 45,000 who end their lives each year in the United States. 11%-20% of those diagnosed with bipolar disorder are believed to take their lives at some point. Overall, suicide has become a national epidemic and is the 10th leading cause of death in the United States.

NRX-101 is a patented, oral, fixed-dose combination of two FDA approved drugs: D-cycloserine, an N- methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, an FDA-approved D2/5-HT2a receptor antagonist. NRX-101 is designed to address bipolar depression with suicidal ideation, an indication for which there is no currently approved drug and for which the only FDA-approved treatment remains electroconvulsive therapy (ECT). NRX-101 has been granted Breakthrough Therapy Designation and Fast Track Designation by the FDA. In addition, NeuroRx has received a Biomarker Letter of Support from the FDA, documenting that the Company had shared evidence of increased glutamine and glutamate (Glx) levels associated with oral administration of D-cycloserine, a phenomenon not seen with serotonin-targeted therapies (SSRI).

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