January 29, 2015 1:59 AM ET

Pharmaceuticals

Company Overview of Naurex, Inc.

Company Overview

Naurex, Inc., a clinical-stage company, develops novel therapies for psychiatry and neurology disorders for modulating the N-methyl-D-aspartic acid receptor (NMDAR). It offers novel chemical drug classes, such as glycine-site functional partial agonists, which modulate the receptor in a different way than existing NMDAR agents. The company provides GLYX-13, an NRX-1050 small molecule series and additional compounds for treatment-resistant depression. It offers its products for central nervous system conditions, including depression, anxiety disorders, cognitive disorders, pain, and addiction. Naurex, Inc. was founded in 2006 and is based in Evanston, Illinois.

1801 Maple Avenue

Suite 4300

Evanston, IL 60201

United States

Founded in 2006

Phone:

847-491-3388

Key Executives for Naurex, Inc.

Chief Executive Officer
Age: 56
Executive Chairman
Age: 76
Chief Medical Officer
Age: 59
Chief Scientific Advisor
Compensation as of Fiscal Year 2014.

Naurex, Inc. Key Developments

Naurex, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 03:00 PM

Naurex, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 03:00 PM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Norbert G. Riedel, Chief Executive Officer, President and Director.

Naurex's GLYX-13 Demonstrates Sustained Antidepressant Effects and Tolerability in Phase 2b Study

Naurex Inc. announced that Phase 2b data presented at the Annual Meeting of the American College of Neuropsychopharmacology demonstrated that repeat-dose adjunctive treatment with GLYX-13, a novel NMDA receptor modulator, resulted in sustained antidepressant effects in subjects with inadequate responses to their current antidepressants. GLYX-13 was well-tolerated with no drug-related serious adverse events reported, including no sign of the psychotomimetic, or psychosis-like, effects associated with NMDA receptor antagonists such as ketamine. These new data confirm the efficacy and safety results from an earlier Phase 2 single-dose study of GLYX-13, which also documented the drug's rapid onset of antidepressant activity in as little as two hours. Unlike most currently approved antidepressants, which act on serotonin and related neurotransmitter pathways in the brain, GLYX-13 works through an entirely different mechanism, mobilizing glutamate pathways to enhance neuronal plasticity and improve the communication between neuronal cells. Dysfunction in these activities is increasingly recognized by scientists as an important contributor to depression and other serious disorders of the central nervous system (CNS). The GLYX-13 Phase 2b study was divided into three parts: a six-week adaptive-dose treatment stabilization period, followed by a six-week randomized withdrawal period and a four-week wash-out period. The study was designed to evaluate safety and efficacy with repeat dosing and to determine optimal dose (5 mg/kg or 10 mg/kg) and dose intervals (weekly or bi-weekly). Subjects were evaluated for changes in depressive symptoms on a weekly basis by off-site independent raters using the HDRS-17 scale. Both subjects and evaluators were blind to the study design. All 386 subjects were dosed with an intravenous bolus injection of GLYX-13 at the beginning of the treatment stabilization period. Subjects received weekly injections of drug until a response was established (reduction in HDRS-17 to a score less than or equal to 50% of pre-dose baseline). Upon achieving response, subjects were then dosed with weekly intravenous injections of placebo to force a relapse in depressive symptoms (increase in HDRS-17 to a score greater than 50% of pre-dose baseline). Upon relapse, subjects were again dosed with GLYX-13 to evaluate whether efficacy could be reestablished. This cycle was repeated with weekly doses of either GLYX-13 or placebo for six weeks. On average, subjects received four injections of GLYX-13 and two injections of placebo during this period. This forced relapse component of the design allowed for evaluation of optimal dose interval, the ability of GLYX-13 to reestablish efficacy if the drug were discontinued, and the antidepressant effects of both drug and placebo in each subject. Subjects who did not respond during the stabilization period were excluded prior to the randomized withdrawal period. During this six-week withdrawal period, subjects were randomized to continue receiving GLYX-13 or to have the drug withdrawn and replaced with placebo. During the following four-week washout period, all subjects received injections of placebo. HDRS-17 is a commonly used instrument that monitors changes in subjects' responses on a number of depressive symptoms such as depressed mode, insomnia, somatic symptoms and difficulty in day-to-day work and activities. The HDRS-17 depression assessment scale was administered to subjects by off-site independent raters. Naurex has completed an end-of-Phase 2 meeting with FDA and is proceeding with its Phase 3 program, expected to begin in 2015.

Naurex, Inc. Presents at Boston CEO Conference, Jun-05-2014 01:00 PM

Naurex, Inc. Presents at Boston CEO Conference, Jun-05-2014 01:00 PM. Venue: Four Seasons Hotel, 200 Boylston Street, Boston, MA 02116, Massachusetts, United States. Speakers: Derek A. Small, Director.

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