Company developing NRX-101 – first potential biomarker-based oral treatment for Acute Suicidal Ideation & Behavior in Bipolar Depression
Wilmington, Delaware , March 20, 2017 (GLOBE NEWSWIRE) — NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB), today announced that Jonathan Javitt, M.D., M.P.H., Chief Executive Officer, will provide a corporate overview at the Oppenheimer 27th Annual Healthcare Conference, being held on March 21-22 at the Westin New York Grand Central. In addition, the company is available to conduct one-on-one meetings with registered attendees of the conference.
Oppenheimer Healthcare Conference Presentation Details
Date: Tuesday, March 21
Time: 3:55-4:25 PM Eastern Time, Track 3
Learn more at NeuroRxpharma.com.
About Bipolar Depression and Acute Suicidal Ideation & Behavior
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, which is called “bipolar depression” and is distinct from the unipolar depression of major depressive disorder, can trigger thoughts of suicide (suicide ideation). For some patients, these thoughts can become strong, creating an urge to develop a plan and/or act upon them, making Acute Suicidal Ideation and Behavior (ASIB) in bipolar depression a uniquely lethal disease.
Patients with bipolar depression who experience acute suicidal crisis, as classified by FDA- recognized scales, have a 30% chance of death within six months. Many patients do seek medical care, or are brought to care by families and physicians, yet there is no approved medicine for the treatment of acute suicidal crisis. Standard-of-care consists of hospitalized observation and frequently electroconvulsive therapy (ECT). In fact, most commonly-used antidepressants bear an FDA-mandated warning label identifying the potential to increase the risk of suicide. Studies show that patients are at continued high-risk for suicide after hospitalization for a suicide attempt.
Each day, approximately 100 Americans, and more than 2,100 people worldwide, end their lives by suicide, according to American Foundation for Suicide Prevention (AFSP) and the World Health Organization (WHO). More than half of all suicides may be related to bipolar disorder.
NRX-101 is a potentially rapid-onset and sustained oral treatment regimen currently in an FDA-cleared phase 2b/3 pending clinical trial for Acute Suicidal Ideation and Behavior (ASIB) in patients with bipolar depression. The treatment, which is currently investigational, is a patented, oral, fixed-dose combination of two FDA- approved drugs: d-cycloserine, a N-methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, a 5-HT2a receptor antagonist. NeuroRx’s investigational treatment approach begins with a single, one-time dose of ketamine for rapid stabilization, followed by approximately six weeks of daily oral NRX-101. Preclinical studies have demonstrated an antidepressant effect comparable to market-leading antidepressants, without the akathisia that occurs in 15% of clinical subjects given standard antidepressants. Peer-reviewed results from two Phase II proof of concept studies showed a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation in patients with bipolar and treatment-resistant depression. Initial peer-reviewed studies measuring brain chemical changes in neurotransmitters (Glx) using Magnetic Resonance Spectroscopy (MRS) have demonstrated beneficial brain chemistry changes that meet or exceed those reported for ECT, without the damaging side effects of ECT.
About NeuroRx, Inc.
NeuroRx draws upon 30 years of basic and clinical science in the role of the N-methyl-D-aspartate (NMDA), a receptor that regulates human thought processes, particularly depression and suicidality. The –company has developed the first NMDA/5-HT2A dual-targeted approach to treatment of depression – a patented scientific advance that has the potential to overcome limitations of previous generations of antidepressant drugs. The NMDA class of drugs, including ketamine, is recognized as having the potential to treat depression decades ago, but has never developed because of propensity to cause hallucination and other side effects. Similarly, the serotonin pathway (SSRI, SNRI, etc.) antidepressants are contraindicated in suicidal patients because of their propensity to cause akathisia, a sideeffect known to be associated with suicidal behavior. NeuroRx scientists have demonstrated, in preclinical and early clinical studies, that combining NMDA and 5-HT2A antagonist agents in the same drug achieves an antidepressant effect that is comparable to that of leading antidepressants, while also blocking akathisia (in preclinical studies) and reducing suicidal ideation in clinical studies. NeuroRx’s rapid drug development platform is enhanced by the discovery that the antidepressant effect of NeuroRx compounds is closely correlated with beneficial changes in brain chemistry, which can be measured non-invasively by Magnetic Resonance Spectroscopy.
NeuroRx was founded by Drs. Jonathan and Daniel Javitt. Jonathan is an Adjunct Professor of the Johns Hopkins School of Medicine and an Alumnus of Merit of the Harvard School of Public Health who has 30 years of experience in development of life-saving drugs. He has served as a White House Health Advisor in three Presidential Administrations and been a founder of six healthcare startups with public exits. Daniel is a Professor of Psychiatry at Columbia University who first discovered the role of the NMDA receptor in psychiatric illness and has published more than 300 scientific works in cognitive neuroscience that have been cited by more than 30,000. He is the inventor of NRX-101. The Company’s executive team includes Dr. Richard Siegel, former Head of the Global Johnson and Johnson drug portfolio and Mr. Robert Besthof, former global VP and commercial lead for Pfizer Neuroscience, Dr. Robert Risinger, former Director of Clinical Studies at Alkermes, and Mr. Wayne Pines, former Associate Commissioner of the US Food and Drug Administration.