Cohen Veterans Bioscience (CVB), a nonprofit research organization dedicated to fast-tracking personalized diagnostics and therapeutics for brain health, today announced its strategic collaboration with Parexel Biotech, a new division of Parexel, for CVB’s adaptive platform trial evaluating pharmacotherapeutics to treat posttraumatic stress disorder (PTSD).

Parexel Biotech will provide clinical trial implementation services over a multi-year period beginning in October 2019. We are delighted to be part of this important adaptive platform trial exploring a precision medicine approach for the treatment of PTSD,” says Parexel CEO Jamie Macdonald. We look forward to partnering with CVB on this innovative trial design in the brain disorders arena and to contributing to this important new therapy, which has significant potential to benefit patients.”

In September 2018, CVB was granted a research award by Advanced Technology International (MTEC Consortium Manager) on behalf of the U.S. Army Medical Research Development Command (MRDC). The award is for a 3.5-year clinical trial to test the efficacy and safety of pharmaco-therapeutics for PTSD via a well-powered adaptive platform trial (APT). CVB will lead this program and serve as the Clinical Coordinating Center (CCC), establishing a clinical trial infrastructure operating within the trial’s governance structure. A government Joint Steering Committee (JSC) is a part of the governance structure and includes representatives from the Veterans Health Administration (VA), the National Institute of Mental Health, National Institute of Alcohol Abuse and Alcoholism, the Food and Drug Administration (FDA), and the Defense Health Agency’s Psychological Health Center of Excellence. For more information read the press release here.

This Phase 2 adaptive clinical trial is scheduled to start in the Fall of 2020 and during the period of performance, at least two active drugs (pending selection) will be evaluated. Biological measurements will be incorporated to support a precision medicine approach to PTSD treatment. A goal of this trial is to identify a drug to advance to Phase 3 testing starting in 2022, and ultimately lead to an additional FDA-approved drug for the treatment of PTSD.

Parexel Biotech is Parexel’s dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively, building on the Company’s heritage of clinical, regulatory, commercial and technology expertise with enhanced strategic consulting and asset development capabilities.

About Posttraumatic Stress Disorder (PTSD)

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 8.6 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 nearly 20 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 FDA.

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.