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.
“T
‘/>”/>
