Cohen Veterans Bioscience (CVB), a nonprofit research organization dedicated to fast-tracking personalized diagnostics and therapeutics for brain health, inked a strategic collaboration with Parexel Biotech, the clinical research organization’s (CRO) new division, for CVB’s adaptive platform trial evaluating pharmacotherapeutics to treat posttraumatic stress disorder (PTSD).
Parexel, one of the world’s largest CROs, has launched Parexel Biotech to support emerging biopharma ventures—a trend with CROs as the industry landscape morphs to include many nimble and agile emerging biopharma sponsors focusing on precision medicine, gene and cell therapy, specialized cancers, etc. In the case of the CVB deal, the CRO’s new unit will partner to help support the implementation of innovative new trial designs targeting brain disorder therapy development.
Posttraumatic Stress Disorder (PTSD) is a mental health condition that some people after experiencing or witnessing a violent or life-threatening event, such as combat, natural disaster, terrorist attack or sexual assault. PTSD affects about 8.6 million American adults each year and is the fifth most prevalent mental disorder in America.
The only approved medications for PTSD treatment includes the selective serotonin reuptake inhibitors (SSRIs) sertraline (Zoloft®) and paroxetine (Paxil®) approved nearly 20 years ago.
Based on positions from the Department of Veterans Affairs (VA) 2017 Consensus Statement of the PTSD Psychopharmacology Working Group there is a deficient pipeline of new PTSD medications and moreover, an assessment of recent trial failures has generated concerns about how to best identify new targets for medication development and optimally design clinical studies.
This collaborative effort seeks to infuse precision research into PTSD clinical trials. For example, in a highly heterogenous patient population such as PTSD, the availability of validated biomarkers or companion diagnostics enables 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 a companion diagnostic for PTSD by the FDA.
U.S. Army Medical Research Development Command (MRDC) Deal
Back in September 2018, CVB was granted a research award by Advanced Technology International (METC Consortium Manager) on behalf of the U.S. Army Medical Research Development Command (MRDC). The award funds a 3.5 year clinical trial to test the efficacy and safety of pharmaco-therapeutics for PTSD via 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.
The PTSD Clinical Trial
A Phase 2 adaptive clinical trial will commence in the Fall of 2020 and during the performance period, 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 key goal of this clinical trial is to identify a drug to advance to Phase 3 testing in 2022 and the hope is to progress toward an FDA-approved drug for the treatment of PTSD.
About Parexel Biotech
Parexel Biotech is Parexel’s dedicated division to support emerging biotech companies in reaching 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. Other CROs have launched similar ventures such as IQVIA.
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