BRANFORD, Conn., April 21, 2011 /PRNewswire/ — Marinus
Pharmaceuticals, Inc., the leader in the development of
neurosteroids for central nervous system disorders, today announced
commencement of a proof-of-concept clinical trial of its lead
candidate ganaxolone for the treatment of posttraumatic stress
disorder (PTSD). Ganaxolone modulates inhibitory GABA-A receptors,
possibly at a specific neurosteroid recognition site. Neurosteroid
levels have been implicated in both the severity and treatment
outcome in PTSD patients.
“This trial will test the hypothesis that a neurosteroid analog
of allopregnanolone will be beneficial in the treatment of PTSD and
augment our existing safety database for ganaxolone in humans,”
stated Gail Farfel, Ph.D., Chief Development and Regulatory Officer
of Marinus. “Achieving full remission of PTSD symptoms is difficult
with current treatments for PTSD. New options that can
increase efficacy are needed for the growing population of PTSD
patients worldwide.”
This randomized, double-blind, placebo-controlled clinical trial
is being conducted by the INTRuST Consortium to evaluate the
safety, tolerability and efficacy of oral ganaxolone after six
weeks of dosing in patients with PTSD. The INTRuST Consortium is a
group of clinical study centers in the United States funded by a
Department of Defense award to advance treatments and medical
research in PTSD and traumatic brain injury. This public-private
collaboration will study ganaxolone under Marinus’ Investigational
New Drug Application (IND) filed with the Food and Drug
Administration (FDA). The trial will take place in the United
States and is designed to enroll approximately 120 PTSD
patients.
“Ganaxolone has been shown in clinical studies to be efficacious
and well tolerated in refractory epilepsy patients, and we expect
the INTRuST PTSD trial to expand ganaxolone’s profile into
neurosteroid-mediated psychiatric disorders,” said Kenneth Shaw
Ph.D., Senior Vi
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