Seelos Therapeutics: FDA Phase II Meeting Outcome for SLS-002 Study Adjustments

Seelos Therapeutics, a biopharmaceutical firm, is advancing its clinical-stage research with a particular focus on therapies for central nervous system (CNS) disorders and rare conditions. The company has recently received guidance from the FDA following their End of Phase II Meeting, which supports the progression of their drug candidate, SLS-002, into a Phase III trial. This drug is being developed to treat Major Depressive Disorder (MDD) in adults who are at an imminent risk of suicide.
The FDA has agreed upon the primary endpoint for the Phase III trial, which will measure the change from the baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 16. A key secondary endpoint will track changes at 24 hours on the suicidality scale. This decision is bolstered by Phase II study results that showed significant treatment differences from placebo on both Day 16 MADRS and the 24-hour Sheehan-Suicidality Tracking Scale (S-STS).
Raj Mehra, Ph.D., Chairman and CEO of Seelos, expressed enthusiasm about the potential of SLS-002 to fulfill an urgent need for treating acute suicidality. The company is committed to designing a robust Phase III trial that will utilize the FDA-agreed endpoints to demonstrate a compelling effect. Tim Whitaker, M.D., Seelos' Chief Medical Officer, expressed gratitude to the FDA for their collaborative approach and highlighted the importance of the data gathered in the Phase II study, which will be instrumental in refining the Phase III study protocol.
The U.S. faces a significant challenge with suicide, having recorded nearly 50,000 suicides in 2022. Currently, there is no FDA-approved treatment specifically for suicidality, leading to substantial healthcare costs and a need for immediate psychiatric care in emergency departments. Seelos aims to address this gap with SLS-002, an intranasal formulation of racemic ketamine, which has shown promise as a rapid and effective treatment for depression and suicidality in clinical studies.
SLS-002 has its roots in a program from Javelin Pharmaceuticals, Inc./Hospira, Inc., and has been subject to 16 clinical studies involving around 500 subjects. The drug candidate is also being considered for the treatment of Post-Traumatic Stress Disorder (PTSD), and Seelos is preparing to participate in an adaptive platform trial by the U.S. Department of Defense (DOD) to evaluate potential treatments for PTSD.
Seelos Therapeutics maintains a diverse portfolio of clinical assets targeting various CNS disorders and rare diseases, including ALS, SCA, Huntington's disease, Alzheimer's disease, and Parkinson's disease. The company's mission is to develop novel therapeutics to meet the unmet medical needs of patients suffering from these conditions.