According to Seelos Therapeutics, the US Army Medical Research and Development Command will include the company’s SLS-002 intranasal racemic ketamine in an adaptive platform trial of therapies for post-traumatic stress disorder (PTSD) in soldiers and veterans. The Phase 2 Department of Defense PTSD Adaptive Platform Trial (NCT05422612), which is expected to be completed in 2026, begins with a 30-day screening period followed by 12 weeks of treatment and then a 4-week follow-up period.
SLS-002 is currently in development for the treatment of suicidal ideation in major depressive disorder. In September 2022, Seelos said that the second half of a Phase 2 trial of the nasal spray would have met its primary endpoint if the study had reached full enrollment.
Seelos Chief Medical Officer Tim Whitaker said, “This study provides an ideal opportunity to study SLS-002 for PTSD. The current approved pharmacologic treatments for PTSD have a number of limitations, and there remains a high unmet medical need. In preparation for inclusion in the study, we conducted additional long-term dosing toxicology studies to support this study, which requires up to 12 weeks of dosing. We look forward to the initiation of this study.”
Chairman and CEO Raj Mehra commented, “Our inclusion in this landmark adaptive platform study, funded by the US Department of Defense, allows us to expedite pursuing indications beyond our current work in acute suicidal ideation and behavior in major depressive disorder. We would like to thank the project managers and subcontractors to this study for their tireless effort in moving this program forward. There remains a significant unmet need for a therapeutic designed to effectively treat PTSD and we unfortunately see too many of our active military and veterans suffer after risking their lives to support and defend our great country.”
Read the Seelos Therapeutics press release.
