Conducting Phase 3 trial for NRX-101, an FDA-designated Breakthrough Therapy for Suicidal Bipolar Depression
WILMINGTON, DE / ACCESSWIRE / November 12, 2019 / NeuroRx, Inc. (NeuroRx) a clinical stage biopharma company focused on development of drugs targeting depression and suicidality, announced today that it will participate in the Solebury Trout KOL Day for analysts and investors on November 15, 2019 at 8:00 AM ET at the White & Case Event Space in New York City. NeuroRx will begin with a brief corporate overview by CEO Jonathan Javitt, MD, MPH, which will be followed by a presentation by Daniel Javitt, M.D., Ph.D., Columbia University Irving Medical School. The presentation is titled Clinical Insights of New Rapidly Acting, NMDA-based Antidepressants.
NeuroRx is developing NRX-101, the first Glx targeted antidepressant in a late stage clinical trial to address suicidality in bipolar depression, under FDA Breakthrough Designation, a Special Protocol Assessment Agreement and Fast-Track Designation. In December 2018 the Company reported Phase 2 efficacy and safety data for NRX-101 versus lurasidone as an active comparator; the data showed the potential for NRX-101 work as an oral, non-addictive outpatient treatment that maintains remission from severe bipolar depression in patients with acute suicidal ideation following an initial stabilization with ketamine. It is estimated that 50% of individuals with bipolar disorder attempt suicide, and 11%-20% succumb to suicide. Today there is no approved drug for bipolar depression with suicidal ideation and the only FDA-approved treatment remains ECT.
Interested parties can access a live webcast of the NeuroRx presentation at the following link https://services.choruscall.com/links/neurorx191115.html . An archived presentation will be available for 30 days.
For more information or to RSVP, institutional investors and sell-side analysts may contact firstname.lastname@example.org.
Dr. Daniel Javitt’s research focuses on brain mechanisms of psychosis and other severe psychiatric disorders, with special emphasis on the role of brain glutamate systems and N-methyl-D-aspartate (NMDA)-type glutamate receptors in health and disease. Dr. Javitt was among the first to demonstrate a link between NMDA dysfunction and schizophrenia, and has been instrumental in developing glutamatergic theories of schizophrenia over the past 20 years. He was also among the first to test new classes of NMDA-based treatments for schizophrenia, including glycine, D-serine and glycine transport inhibitors, and has more recently initiated studies of NMDA receptor antagonists, such as ketamine and high-dose D-cycloserine in treatment of depression, and of brain stimulation methods, including transcranial direct current stimulation (tDCS) as an adjunct to cognitive remediation.
NeuroRx draws upon 30 years of basic science and clinical expertise in the role of N-methyl-D-aspartate (NMDA), a receptor that regulates human thought processes, particularly depression and suicidality, as well as PTSD. The company is privately funded and led by former senior executives of Johnson & Johnson, Pfizer Inc., Eli Lilly, and Astra-Zeneca. NeuroRx’s Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary for Planning and Evaluation, Department of the U.S. Health and Human Services; Chaim Hurvitz, former President, TEVA International Group; Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.
NRX-101 is a patented, oral, fixed-dose combination of two FDA approved drugs: D-cycloserine, a N-methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, which has D2/5-HT2a receptor antagonist activity. D-cycloserine has shown activity against depression in four clinical studies. It has also shown an effect on suicidality in some of these studies. NRX-101 is designed to address bipolar depression with suicidal ideation, an indication for which there currently is no approved drug and for which the only FDA-approved treatment remains electroconvulsive therapy (ECT). NeuroRx was granted Fast Track designation by the U.S. FDA for this indication in August 2017. In May of 2018 NeuroRx was awarded a Special Protocol Agreement (SPA) by the FDA for the NRX-101 phase 2b/3 trial. In April 2018, NeuroRx received a biomarker letter of support from the FDA, documenting that the company had shared evidence of increased Glx levels associated with oral administration of D-cycloserine, a phenomenon not seen with serotonin-targeted drugs (SSRI). In November 2018, the FDA awarded NeuroRx Breakthrough Therapy designation for NRX-101.