Cohen Veterans Bioscience, a Cambridge, MA based 501c(3) non-profit research organization will establish a clinical trial infrastructure and serve as the Clinical Coordinating Center for a 3.5-year study to comparatively test pharmacotherapeutics for PTSD under an award managed by Advanced Technology International (MTEC Consortium Manager) on behalf of the U.S. Army Medical Research and Materiel Command (MRMC).

PTSD is a mental health condition that some people develop after experiencing or witnessing a violent or life-threatening event, such as combat, natural disaster, terrorist attack, or sexual assault. Symptoms of PTSD can include reliving the event or having flashbacks; avoiding situations that trigger the memories; losing interest in activities or feelings of fear, guilt, or shame; feeling anxious or always on alert for danger. PTSD affects about 7.7 million American adults each year and is the fifth most prevalent mental disorder in the United States. Overall prevalence rates among veterans of different conflicts range from 10-30% (OEF/OIF/OND/Gulf War/Vietnam).

The only approved medications for the treatment of PTSD are the selective serotonin reuptake inhibitors (SSRIs) sertraline (Zoloft) and paroxetine (Paxil) approved over 17 years ago. The Department of Veteran Affairs (VA) 2017 Consensus Statement of the PTSD Psychopharmacology Working Group concluded that there is a deficient pipeline of new PTSD medications and an assessment of recent trial failures has generated concerns about how to best identify new targets for medication development and optimally design clinical studies. In a highly heterogeneous patient population such as PTSD, the availability of validated biomarkers or companion diagnostics would allow clinicians to predict the likelihood that a given patient would respond to a given therapeutic, enabling individualized medicine for these conditions. No biomarkers have been qualified nor cleared as companion diagnostics for PTSD by the Food and Drug Administration.

Most critically, the field has historically conducted the majority of clinical trials using “traditional trial design” approaches. These approaches are generally time-consuming, have been associated with high failure rates, and are expensive, as they often result in starting over in a new trial with lessons learned.

CVB will be spearheading the design and application of “Smart-” or “Adaptive-” clinical trials for PTSD. These studies include a prospectively planned opportunity for modification of one or more specified aspects of the study design based on data (usually interim data) collected from subjects in the study. To execute such a program, a centrally-managed platform clinical trial infrastructure will be established, potentially including academic, private, VA, and military research centers.

“Advancing our understanding of disease while promoting a precision medicine approach for the treatment of PTSD is fundamentally important to help us support our mission to protect, treat and sustain the health of Service Members,” said Dr. Kimberly A. del Carmen, who will serve as Sponsor Office Technical Representative on behalf of the U.S. Army Medical Materiel Development Activity Neurotrauma and Psychological Health Project Management Office.

“The unique and innovative aspects of an adaptive platform trial approach for testing therapeutics for PTSD is in the ability to capitalize on the information you gather while the study is ongoing,” said Allyson Gage, PhD, Chief Medical Officer at CVB and Head of the Adaptive Trial Program. “Clinical trial networks capable of conducting these trials with high fidelity is a critical piece of de-risking drug development in psychiatric trauma-related conditions.”

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