Seelos Therapeutics reports selection of SLS-002 for inclusion into DoD trial

Seelos Therapeutics announced that SLS-002 has been selected for inclusion in an adaptive platform trial to evaluate treatments for post-traumatic stress disorder in active-duty service members and veterans. The trial is funded by the U.S. Department of Defense’s Defense Health Agency and led by the Warfighter Readiness, Performance, and Brain Health Project Management Office, part of the U.S. Army Medical Materiel Development Activity. “Our inclusion in this landmark adaptive platform study, funded by the U.S. Department of Defense, allows us to expedite pursuing indications beyond our current work in acute suicidal ideation and behavior in major depressive disorder,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. The Department of Defense PTSD Adaptive Platform Trial is a Phase II randomized, double-blinded, placebo-controlled study that will evaluate the safety, tolerability, and efficacy of multiple pharmacotherapeutic interventions in active-duty service members and veterans with PTSD. The trial will utilize an adaptive platform trial design randomizing participants among the multiple treatment cohorts selected for inclusion in the study and enable sharing of control participants to increase study efficiency. The design of the trial entails a 30-day screening period, a 12-week treatment period and a 4-week safety follow-up and will collect data to measure changes in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale-5-Revised and other clinically relevant endpoints, including the incidence of new or worsening suicidal thoughts or behaviors, as measured by change in the Columbia Suicide Severity Rating Scale score. In addition, the trial will evaluate several biomarkers associated with PTSD and assessments of treatment safety and tolerability.