Phase II Data Presented at Acnp 2012 Shows Novel Antidepressant Glyx-13 Significantly Reduces Depression Scores Within Hours
—A Single Dose of Naurex’s Novel NMDA Receptor
Modulator Produce Statistically Significant Reductions in
Depression Scores Within 24 Hours that Lasted 7 Days in Subjects
Who Had Failed Other Therapies—
—Antidepressant Efficacy as Measured by “Effect
Size” Was Nearly Double that of Conventional
Antidepressants—
—No Psychotomimetic or Other Serious Side Effects Were
Observed—
HOLLYWOOD, FL and EVANSTON, IL, December 6, 2012 -- Naurex Inc., a
clinical-stage company developing innovative treatments to address
unmet needs in psychiatry and neurology, today reported positive
results from a Phase IIa clinical trial of its lead antidepressant
compound, GLYX-13. GLYX-13 is a novel partial agonist of the NMDA
receptor. The Phase Ila results are being presented this week at
the 51st Annual Meeting of the American College of
Neuropsychopharmacology (ACNP).
The Phase IIa results show that a single administration of GLYX-13
produced statistically significant reductions in depression scores
in subjects who had failed treatment with one or more
antidepressant agents. The reductions were evident within 24 hours
and persisted for an average of seven days. Importantly, the effect
size, a measure of the magnitude of the drug’s antidepressant
efficacy, observed at 24 hours and at seven days after a single
administration of GLYX-13, was nearly double the effect size seen
with most other antidepressant drugs after 4-6 weeks of repeated
dosing.
In the Phase IIa trial, GLYX-13 was well tolerated. Reported side
effects were mild to moderate and were consistent with those
observed in subjects receiving placebo. Consistent with previous
studies, GLYX-13 did not produce any of the schizophrenia-like
psychotomimetic effects associated with other drugs that modulate
the NMDA receptor.
“These data are an important step in validating
Naurex’s mission of developing breakthrough therapies for
depression and other CNS disorders,” said Derek Small, CEO of
Naurex. “Our founder discovered a new class of drugs that
appeared to have the remarkable antidepressant efficacy of
ketamine-like compounds, but without their limiting side effects.
These Phase II results suggest that this discovery may translate
into measurable health improvements for individuals with
depression, which bodes well for the future success of GLYX-13 and
the other promising compounds we have generated from this
platform.”
Other NMDA receptor-modulating agents, such as ketamine, have been
shown in several human clinical trials to act very rapidly to
alleviate the symptoms of depression and bipolar disorder, but
their clinical utility has been hampered by their potential for
abuse and behavioral impairment, including schizophrenia-like
effects at therapeutic doses.
“We are encouraged by these promising data,” noted
Ronald M. Burch, MD, PhD, Chief Medical Officer of Naurex.
“We have recently begun dosing patients in a GLYX-13 Phase
Ilb repeated dose trial, and we are on track to advance our
second-generation oral compound, NRX-1074, into clinical trials
next year. Preclinical studies show that our novel NMDA modulators
may be applicable to a number of CNS disorders, and we look forward
to assessing their potential to address major unmet needs in
psychiatry and neurology.”
The Phase Ila trial was a randomized, double blind,
placebo-controlled study of the efficacy and safety of a single
dose of intravenous GLYX-13 in subjects who had failed at least one
other antidepressant during the current depressive episode. It was
conducted at 12 clinical centers in the U.S. Outcome measures
included ratings of signs, symptoms and changes in depression
scores on standard rating scales for mood and psychiatric
disorders. Independent raters from MedAvante, who were blinded to
the protocol, administered certain psychiatric assessments for the
trial to ensure the quality and objectivity of the screening and
rating data. Safety was also assessed.
Naurex’s CNS programs are based on the work of company
founder, Joseph R. Moskal, PhD, and his colleagues at the Falk
Center for Molecular Therapeutics at Northwestern University.
The 51st Annual Meeting of the American College of
Neuropsychopharmacology is being held December 2-6, 2012 in
Hollywood, Florida. For more information, visit
www.acnp.org/annualmeeting/default.aspx.
About Naurex
Naurex 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. Naurex’s lead product, GLYX-13, has shown promising
antidepressant activity with excellent safety in a Phase II trial,
confirming the efficacy signals and safety observed in Phase I and
preclinical studies. In a Phase II trial in subjects who had failed
treatment with one or more antidepressant agents, a single
administration of GLYX-13 produced statistically significant
reductions in depression scores within 24 hours, which persisted
for an average of seven days. Naurex’s second-generation
programs include a number of molecules with preclinical proof of
concept. The company’s patented novel chemistry classes
represent a platform for the development of new therapies for a
variety of CNS disorders. For more information about Naurex, visit
www.naurex.com.
Barbara Lindheim
BLL Partners, LLC
blindheim@bllbiopartners.com
1370 Broadway, 5th floor
New York, NY 10018
212.584.2276 (office)
917.355-9234 (mobile)
Posted: December 2012
