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:2/4/2016)... Feb. 4, 2016  SciClone Pharmaceuticals, Inc. (NASDAQ: ... has entered into a settlement agreement with the ... resolving the SEC,s investigation into possible violations of ... terms of the settlement agreement, SciClone has agreed ... disgorgement, pre-judgment interest and a penalty.  This payment ...
(Date:2/4/2016)... -- Global Immunology Market to 2022 - Large ... growth Summary Immune-mediated inflammatory diseases are ... affect 5–7% of western populations. Although they are ... key patient demographics, they are pathophysiologically linked, being ... inappropriate immune response. Generally, disease-modifying anti-rheumatic drugs, a ...
(Date:2/4/2016)...  Aethlon Medical, Inc. (Nasdaq: AEMD ), ... treat life-threatening diseases, today announced results for the ... 2015. --> --> ... our last quarterly call, we strategically advanced pre-clinical ... to establish the Aethlon Hemopurifier® as a leading ...
Breaking Medicine Technology:
(Date:2/5/2016)... York, New York (PRWEB) , ... February 05, 2016 , ... ... life? The answer may be at the tips of your toes. Foot massage, whether ... as well as pure comfort and relaxation. The American Board of Multiple Specialties ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... franchises from across the country gathered at the La Valencia Hotel in San ... PROSHRED Chicago was named the year’s most outstanding franchise, walking away with ...
(Date:2/5/2016)... ... 05, 2016 , ... Pivot Point Consulting, a leading national ... & Services for HIT Implementation Support & Staffing report with an outstanding score ... by healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 clinics. ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Colorize ... from on one drop zone to the next using Colorize's dynamic moving camera. Colorize ... project. This package includes a 3D slideshow environment with 1 to 5 focus points ...
(Date:2/5/2016)... ... 05, 2016 , ... Calls Blacklist has just been updated by mobile app ... the developer has fixed known bugs within the app. Calls Blacklist allows its users ... not consuming any of their device’s battery power or memory. It provides a powerful ...
Breaking Medicine News(10 mins):