Navigation Links
Naurex Initiates Phase II Clinical Trial of Novel Antidepressant GLYX-13 in Treatment-Resistant Depression
Date:6/22/2011

EVANSTON, Ill., June 22, 2011 /PRNewswire/ -- Naurex Inc., a clinical-stage company developing innovative treatments to address unmet needs in psychiatry and neurology, today announced that it has initiated a Phase II clinical trial of its lead compound GLYX-13.  GLYX-13, a Glycine-site Functional Partial Agonist (GFPA) selective modulator of the NMDA receptor (NMDAR), is initially being developed as a therapy for patients who are not achieving an adequate response to their current antidepressant agents.  Screening and enrollment of subjects in the Phase II study are currently underway.

Naurex's novel GFPA class of compounds has demonstrated the potential to achieve the well-documented efficacy of classic NMDAR-modulating drugs while avoiding their serious side effects.  Known NMDAR-modulating agents such as ketamine have been shown to act very rapidly -- within hours of a single dose -- to alleviate the symptoms of depression and bipolar disorder in a number of human clinical trials, but their clinical utility has been hampered by their potential for abuse and behavioral impairment, including schizophrenia-like effects at doses near the therapeutic dose.

The GLYX-13 Phase II trial is a randomized, double-blind, placebo-controlled study of the efficacy and safety of GLYX-13 in treatment-resistant depression.  The trial is intended to enroll 80 subjects with major depressive disorder who have demonstrated inadequate or partial response to other antidepressants.  Outcome measures include ratings of signs, symptoms, and changes in depression scores on standard rating scales for mood and psychiatric disorders.  Safety is also being assessed.

"GLYX-13 is the first in a new class of antidepressants designed to achieve the rapid onset and breakthrough efficacy of classic NMDAR modulators, but without their prohibitive side effects," said Ronald Burch, M.D., Ph.D., chief medical officer at Naurex.  "There is a high unmet need for faster, more effective and safe antidepressants to help the millions of patients poorly served by current agents.  We look forward to reporting the results of this first assessment of the potential efficacy of GLYX-13 in patients with treatment-resistant depression during 2012."

In preclinical studies, GLYX-13 has demonstrated the robust antidepressant-like activity of ketamine, including its rapid onset and long duration of effect, with no signs of side effects.  It also achieved the widest therapeutic ratio between efficacy and side effects (>500:1) of any known NMDAR modulator.  

In a Phase I trial, GLYX-13 was well tolerated, with adverse events for the groups receiving GLYX-13 and placebo all rated as mild.  There were no signs of the schizophrenia-like side effects associated with other drugs that modulate the NMDAR.

For more information about the GLYX-13 Phase II trial, see http://clinicaltrials.gov/ct2/show/NCT01234558?term=glyx-13&rank=2.

About NaurexNaurex Inc. is a clinical-stage private company developing novel therapies to address unmet needs in psychiatry and neurology based on a new mechanism of action for modulating the NMDA receptor in a safe way -- Glycine-site Functional Partial Agonists (GFPAs).  In preclinical studies, Naurex's lead product, GLYX-13, has shown promising signs of rapid-acting, long-lasting antidepressant activity with excellent safety, and the safety results have been confirmed in a Phase I clinical trial.  Naurex is currently conducting a Phase II trial to assess GLYX-13 in patients who have had an inadequate response to an existing antidepressant treatment.  Naurex's second-generation program, which comprises novel patented GFPA chemistry classes with key molecular features, represents a platform for the development of new therapies for a variety of CNS disorders and includes a number of molecules that have demonstrated preclinical proof of concept.  The GFPA program is based on the work of Naurex founder Dr. Joseph R. Moskal and his colleagues at the Falk Center for Molecular Therapeutics at Northwestern University.  For more information about Naurex, visit www.naurex.com. Contacts: Corporate

MediaNaurex Inc.

GendeLLindheim BioCom PartnersAshish Khanna

Barbara LindheimVice President, Corporate Development

212 918-4650847 871-0377

blindheim@biocompartners.comcorporate@naurex.com
'/>"/>

SOURCE Naurex Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Naurex Inc. Initiates Phase I Clinical Trial of its Novel Mechanism NMDA Modulator GLYX-13 in Treatment-Resistant Depression
2. Naurex Inc. Announces Presentation of Preclinical Data Showing its Novel Mechanism NMDA Modulator Exhibits Robust and Rapid-Onset Antidepressant Activity With No Signs of Classic NMDA-Associated Side Effects
3. Cebix Initiates Phase 1b Clinical Trial with Drug Candidate Ersatta™
4. American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
5. Sangart Initiates Phase 2b Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock
6. Masimo Initiates Limited Market Release of E1, Single-Patient-Use Ear Sensor for Pulse Oximetry Monitoring
7. Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients
8. American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP, 50 mL Single Dose Vial Due to Particulate Matter
9. ViroPharma Initiates Phase 2 Study of VP 20621 for Prevention of Recurrence of Clostridium difficile Infection (CDI)
10. BAETA Corp Initiates Clinical Trial at NYU School of Medicine to Measure Efficacy of Pain Recording Device
11. Vista Partners Initiates Coverage on Helix BioPharma Corporation; Target Price $6.20
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... COLOGNE, Germany , May 3, 2016  Axiogenesis has acquired a major investment from Sino-German High-Tech Fund to ... http://photos.prnewswire.com/prnh/20160503/362920    Photo - http://photos.prnewswire.com/prnh/20160503/362921 ... ... ... ...
(Date:5/3/2016)... ACME Markets, Delaware County ... County Councilman Dave White announced today the ... ACME pharmacies across Delaware County . ... naloxone has saved 26,463 lives nationwide over the past 20 years. ... were authorized to administer naloxone to overdose victims, 244 ...
(Date:5/3/2016)...  While you may be familiar with watching a film or TV show in high definition, ... 8MP in the Medical Industry.  Ampronix  is a renowned authorized reseller of the medical industry,s ... - http://photos.prnewswire.com/prnh/20160502/362730 ... ... ...
Breaking Medicine Technology:
(Date:5/5/2016)... Francisco, CA (PRWEB) , ... ... ... intensive lectures and hands-on exercises, the Wharton Seminars for Business Journalists ... a better understanding of key business and economic issues.  This one-day program ...
(Date:5/5/2016)... ... May 05, 2016 , ... Every ... the most heartfelt wishes of these children. The wishes provide hope and ... President and CEO of Make-A-Wish Mississippi, Brent Wilson said, “In 2016, the organization ...
(Date:5/5/2016)... ... ... A recent survey by the Midwest Business Group on Health ... use the free preventive care benefits available to them as part of the Affordable ... public and private employers, MBGH found that only 10% of large employers are aware ...
(Date:5/5/2016)... , ... May 05, 2016 , ... ... Pittsburgh-area schoolchildren has found that more than 40 percent of participating fifth-grade students ... , Director of Allergy and Asthma Clinical Research in the Division of Pulmonary, ...
(Date:5/5/2016)... ... May 05, 2016 , ... ... presented a talk highlighting the organization’s successful Care Transitions program at ... The talk was titled “Minimizing Costs in the Post-Acute Environment Through Effective Transitions ...
Breaking Medicine News(10 mins):