Basel, Switzerland, November 3 2008 – Synosia Therapeutics today announced the start of a phase IIa clinical trial with nepicastat (SYN-117), for the treatment of post-traumatic stress disorder (PTSD).
The trial is funded by the United States Department of Defense (DoD) and will be a prospective, randomized double-blind, placebo-controlled study of nepicastat, a dopamine β hydroxylase (DBH) inhibitor, in veterans of Operation Iraqi Freedom and Operation Enduring Freedom.
The primary aim of the study is to assess the efficacy and tolerability of nepicastat in the treatment of PTSD-induced hyperarousal, with the secondary aims of assessing its ability to improve other symptoms of PTSD, induce remission and improve quality of life.
The trial will be conducted by three leading researchers in the field of PTSD:
- Lori L. Davis, M.D., principal investigator for the study and Professor of Psychiatry, School of Medicine, University of Alabama at Birmingham, and Chief of Research Service at the Tuscaloosa Veterans Affairs (VA) Medical Center
- Tom Kosten, M.D., partnering principal investigator and Jay H Waggoner Chair and Professor of psychiatry and Neuroscience at Baylor College of Medicine and Research Director of the (VA) National Substance Use Disorders Quality Enhancement Research Initiative (QUERI), based at the Michael E. DeBakey VA Medical Center in Houston
- Mark Hamner, M.D., partnering principal investigator and Professor, Department of Psychiatry and Behavioural Sciences, Medical University of South Carolina and Director, Psychopharmacology Research and Medical Director of the PTSD Clinical Team at the Department of Veterans’ Affairs Medical Center, Charleston, South Carolina
“PTSD is a disabling and debilitating condition that has a major negative impact on people who have often suffered significant trauma in their lives,” said Dr Davis principal investigator. “There is an urgent need for new treatments that will effectively manage the distressing hyperarousal and hypervigilence, symptoms commonly experienced by people with PTSD.”
“We are delighted to be starting our phase IIa clinical trials with nepicastat for the treatment of PTSD with three leading researchers in the field,” said Ian Massey, Synosia’s Chief Executive Officer and President. “Nepicastat has recently been highlighted by the leading competitive intelligence group, Thomson Reuters, as one of the five most promising drugs across all therapeutic areas to enter phase II clinical trials in the April – June period. This is certainly a positive endorsement for this promising new treatment.”
About Post-Traumatic Stress Disorder
Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure to a major traumatic event or ordeal in which grave physical harm occurred or was threatened.
Once associated mainly with veterans of the Vietnam War and subsequent conflicts, PTSD is now recognized in even greater numbers among civilians exposed to traumatic events. It may be accompanied by depression and substance abuse.
In the United States about 8% of the population will have PTSD symptoms at some point in their lives. During any given year this equates to 5.2 million adults in America living with PTSD.1
About Nepicastat (SYN-117)
Nepicastat inhibits dopamine β-hydroxylase (DBH), the enzyme responsible for the conversion of dopamine into norepinephrine. Nepicastat has been shown to increase brain and blood concentrations of dopamine and decrease those of norepinephrine in animals.
Nepicastat is administered orally and has been well tolerated in studies including over 250 people in other therapeutic indications, some receiving treatment for several months.
Rights to nepicastat were obtained from Roche in 2007. In addition to PTSD, Synosia has initiated studies to evaluate nepicastat in drug dependency.
About Synosia Therapeutics
Synosia Therapeutics develops and intends to commercialise innovative and clinically differentiated products for unmet medical needs in psychiatry and neurology. The privately-owned company has in its pipeline six clinical-stage compounds acquired through key partnerships with Novartis, Roche and Syngenta. Two of the compounds are marketed drugs being tested in new indications to extend their reach into neurological and psychiatric diseases with high unmet medical need, including anxiety and Parkinson’s disease. Synosia’s headquarters is in Basel, Switzerland. For more information visit www.synosia.com
This communication, and oral statements made with respect to information contained in this communication, expressly or implicitly contains certain forward-looking statements concerning Synosia Therapeutics and its business. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact including, but not limited to our plans for our regulatory filings, enrolment and future plans for our clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities. The words “potential”, “could” and similar expressions also identify forward-looking statements. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results include risks associated with the possibility that the respective regulatory agencies refuse approval of our applications, the outcome of any discussions with such regulatory agencies and unexpected delays in preparation of materials for submission to such respective regulatory agencies as a part of our filings.
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1. National Center for PTSD Factsheet. National Center for Post-Traumatic Stress Disorder, United States Department of Veterans Affairs website. www.ncptsd.va.gov/ncmain/mcdoc/fact_shts. Last accessed October 20 2008