Idorsia Pharmaceuticals will participate in a Phase II trial in post-traumatic stress disorder (PSTD) sponsored by the US Department of Defense (DOD). The Switzerland-headquartered biopharma company is providing its approved Quviviq (daridorexant) and matching placebo to the DOD.
Idorsia will also provide access to a validated measurement tool called the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Further analysis will provide additional information and data about the drug in the PTSD population, including sleep parameters.
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptide orexin. The mechanism of action is believed to turn down overactive wake signalling, while other insomnia medications cause sedative effects on the central nervous system.
In 2022, the drug received approval in the US and EU for insomnia. Last week, Idorsia secured marketing authorisation from Health Canada to manage insomnia in adult patients.
The adaptive trial design
The adaptive platform clinical trial (NCT05422612) plans to enrol 600 participants who are active-duty US service members and veterans with PTSD. The study will investigate Quviviq alongside two FDA-approved drugs for the treatment for depression fluoxetine and vilazodone hydrochloride. All drugs will be studied under an Investigational New Drug (IND) application for the treatment of PTSD.
The general structure of the adaptive platform trial will consist of a 30-day screening period, a 12-week platform treatment period, and a four-week safety follow-up. The enrolment into the three-arm trial will continue until a decision is made to stop all of the cohorts.
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Unblinded data will be reviewed by an Independent Statistical Analysis Committee (ISAC) and a Data Safety Monitoring Board (DSMB) at quarterly interim analyses. At each analysis, enrolment may be stopped at each cohort for futility, anticipated success or reaching the maximum sample size.
The study plans to enrol the first subject in Q2 2023, while the Quviviq arm is expected to run for approximately three years.
The primary endpoint will measure absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month and incidence of new or worsening suicidal thoughts or behaviours as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline at week 12.
Dr Kimberly del Carmen, the DOD’s PTSD Drug Treatment Program Product Manager at the U.S. Army Medical Materiel Development Activity (USAMMDA) said: “This innovative clinical trial and public-private partnership addresses the need for safe and effective therapies to treat PTSD in our current and former servicemen and women, as well as the general population.”
PTSD is a psychiatric disorder that can occur in people who endured or witnessed a traumatic event. According to GlobalData’s epidemiologists, women are more likely to develop PTSD than men and policymakers and healthcare professionals are urged to be aware of the high burden of this disorder in women.