Marinus has two public-private collaborations investigating ganaxolone for the treatment of posttraumatic stress disorder (PTSD) or fragile-X syndrome (FXS).

Collaboration with INTRuST Consortium for PTSD

The INTRuST Consortium is a group of clinical study sites funded by the Department of Defense to investigate promising new treatments for PTSD and traumatic brain injury. The INTRuST consortium coordination center is directed by Murray B. Stein, MD. MPH, at the University of California San Diego. Under this public-private agreement, Marinus holds the Investigational New Drug (IND) application, provides regulatory support and drug supplies. INTRuST runs all other aspects of the clinical study. Dr. Christine Marx, MD, MA of Duke University Medical Center/ Durham VA Medical Center and Dr. Ann Rasmusson, MD of Boston University School of Medicine/ VA Boston Healthcare Service are the lead investigators of this study.

The PTSD study design is a double blind, placebo-controlled crossover design in which subjects with PTSD (approx. 120) are treated with ascending b.i.d. doses of ganaxolone or placebo for 6 weeks followed by an additional 6 weeks of dosing in which all patients receive ganaxolone. Additional information about the trial is available on www.clinicaltrials.gov. Additional information about the INTRuST Consortium can be found at http://intrust.sdsc.edu.

Collaboration with the MIND Institute for Fragile-X Syndrome

The MIND institute at the University of California Davis (UCD) has recently been awarded a Department of Defense Medical Research Grant to study ganaxolone in fragile-X syndrome (FXS). The grant was awarded to three UCD Principal Investigators: Randi Hagerman, MD, Michael Rogawski, MD, PhD, and David Hessl, PhD. The FXS clinical trial is expected to start in the first half of 2012.