Naurex's Novel Antidepressant GLYX-13 Recognized as One of Windhover's Top 10 Neuroscience Projects to Watch
--Independent Committee Selects Naurex's Novel NMDA Modulators for Prestigious List of Most Promising CNS Candidates--
EVANSTON, Ill., Aug. 31 /PRNewswire/ -- Naurex Inc., a clinical
stage company developing innovative treatments for depression and
other CNS disorders, today reported that its clinical stage
candidate for the treatment of depression, GLYX-13, and its
second-generation NRX-1050 series have been selected for inclusion
on Windhover's list of the "Top 10 Most Interesting Neuroscience
Projects to Watch." They were chosen by a committee that included
Windhover Information, the publishers of IN VIVO and Start-Up, and
independent CNS expert Harry Tracy, president of NI Research and
editor of the neuroscience business analysis journal
NeuroInvestment.
GLYX-13 and the molecules in the NRX-1050 series represent a
novel mechanism at a well-known target--they are glycine-site
functional partial agonist selective modulators (GFPAs) of the NMDA
receptor (NMDAR) that have been designed to be devoid of the
limiting side effects of classic NMDAR-modulating drugs while
maintaining their well-documented efficacy.
GLYX-13 is in clinical development for treatment-resistant
depression and has demonstrated a positive safety profile in a
Phase I trial. In preclinical studies, GLYX-13 has shown promising
signs of robust antidepressant activity with excellent safety,
demonstrating rapid onset of effect and long duration after a
single administration. Naurex will initiate a Phase II
proof-of-concept trial later this year to evaluate GLYX-13 in
patients who are not achieving an adequate response to their
current antidepressant agents.
"We are delighted that these respected industry experts have
selected our novel NMDA receptor modulators as among the most
promising candidates in the CNS field," said Derek Small, acting
CEO of Naurex. "Treatment-resistant depression is a debilitating
condition that affects millions of people. We are optimistic that
GLYX-13 and our NRX-1050 series have the potential to make a
dramatic difference for these patients, helping those poorly served
by existing therapies and providing relief within hours--rather
than weeks--of receiving a single dose. Both programs have also
demonstrated potential in a number of other CNS indications."
The NRX-1050 series of GFPAs comprises numerous
second-generation, orally available molecules with structures and
mechanisms of action similar to GLYX-13. This series includes
multiple potential lead molecules, and in vivo proof-of-concept
data have been generated for a number of the candidates.
"Selected companies have been screened using a strict set of
judging criteria for the Top 10 award and represent what our
committees considered the most attractive neuroscience
opportunities the industry has to offer," said David Cassak, vice
president, content, Windhover Conferences, a division of Elsevier
Business Intelligence. "Winners have met rigorous criteria,
including: unmet medical need, market potential, diversity of
indications, strong science, multi-level partnering opportunities
(biotech and pharma), potential for new opportunities beyond
initial indications and corporate stability."
Along with inclusion in the "Top 10 to Watch" list, Naurex has
been selected to present at Windhover's Therapeutic Area
Partnerships meeting, which will be held November 2-4, 2010 at the
Westin Copley Place in Boston, MA. More information on the meeting
can be found at www.tapartnerships.com.
About NMDA Receptor Modulators and Depression
The glutamate receptor subtype known as NMDA plays a central
role in modulating aspects of brain activity. The antidepressant
effects of known NMDAR modulators, such as ketamine, have been
confirmed in multiple clinical studies over the last decade. These
studies have shown dramatic efficacy in patients with
treatment-resistant depression, demonstrating response rates
greater than 50%, fast onset of action within hours of a single
dose and a long duration of effect. The antidepressant efficacy of
ketamine has been underscored in recent studies published in
Science and by NIMH researchers in the Archives of General
Psychiatry. But ketamine and other known NMDAR blockers are also
associated with significant toxicities at or near their therapeutic
doses. These side effects, which include schizophrenia-like
effects, sedation and abuse and addiction potential, have limited
the therapeutic potential of these agents. In studies to date,
Naurex's novel GFPA agents have shown the significant efficacy of
other NMDAR modulators, but without their limiting side
effects.
About Glycine-Site Functional Partial Agonists
GFPAs modulate the NMDA receptor in a novel and selective way
that results in the largest therapeutic index of any known NMDAR
modulator. GFPAs are being developed with the goal of achieving the
antidepressant efficacy and rapid onset seen with conventional
NMDAR modulators, but without their limiting side effects. The
efficacy potential of GFPAs has been demonstrated in animal models
in a number of CNS diseases, including major depressive disorder,
neuropathic pain, schizophrenia, anxiety, Alzheimer's disease and
other cognition disorders. In these studies, GFPAs did not exhibit
the schizophrenia-like side effects associated with conventional
NMDAR modulating drugs. In preclinical studies, Naurex's lead drug
candidate, GLYX-13, has demonstrated a wide therapeutic ratio
between efficacy and side effects (>/=500:1). Preclinical
studies also have shown that the antidepressant effects of GLYX-13
were evident within 20 minutes and lasted at least two weeks after
administration of a single dose.
About Naurex
Naurex Inc. is a private company developing novel therapies for
depression and other CNS disorders based on a new mechanism of
action for modulating the NMDA receptor in a safe way--glycine-site
functional partial agonists (GFPAs). Naurex's lead product,
GLYX-13, has shown promising signs of antidepressant activity with
excellent safety in preclinical studies. These safety results have
been confirmed in a Phase I clinical trial. Later this year, Naurex
plans to initiate a Phase II trial assessing GLYX-13 in patients
who have had an inadequate response to first-line treatment. Naurex
has patented these novel GFPA chemistry classes and key molecular
features that may represent a platform for the development of new
therapies for a variety of CNS disorders. For more information,
visit www.naurex.com.
About Windhover
Windhover Information Inc., an Elsevier company, has provided
analysis of the healthcare industry to decision-makers at all
levels since the founding of its flagship publication, IN VIVO: The
Business & Medicine Report, in 1983. Windhover provides its
information and analysis in many formats, including print,
electronic databases, international conferences and webinars. For
more on the company's products and services, please see
www.windhover.com.
References
Cryan, J.F., O'Learty, O.F., A Glutamate Pathway to
Faster-Acting Antidepressants? Science. 2010 Aug;
329(5994):913-4.
Li, N., Lee, B., Liu, R., Banasr, M., Dwyer, J.M., Iwata, M.,
Li, X., Aghajanian, G., Duman, R., mTOR-Dependent Synapse Formation
Underlies the Rapid Antidepressant Effects of NMDA Antagonists,
Science. 2010 Aug; 329(5994):959-62.
Machado-Vieira, R., Salvadore, G., Luckenbaugh, D.A., Manji,
H.K., Zarate, C.A. Jr., Rapid onset of antidepressant action: a new
paradigm in the research and treatment of major depressive
disorder, J Clin Psychiatry. 2008 Jun; 69(6):946-58.
Skolnick, P., Popik, P., Trullas, R., Glutamate-based
antidepressants: 20 years on, Trends Pharmacol Sci. 2009 Nov;
30(11):563-9.
Contacts: Corporate Media Naurex Inc. GendeLLindheim BioCom Partners Ashish Khanna Jennifer Anderson Vice President of Business Development 212 918-4642 ashishkhanna@naurex.com
Source: Naurex Inc.
CONTACT: Ashish Khanna, Vice President of Business Development,
Naurex
Inc., ashishkhanna@naurex.com, or
Jennifer Anderson, GendeLLindheim BioCom
Partners, +1-212-918-4642
Web Site: http://www.naurex.com/
Posted: August 2010
