Seelos Therapeutics signs Material Transfer Agreement with USAMMDA to evaluate SLS-002 for PTSD treatment

Seelos Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in therapies for central nervous system disorders and rare diseases, has announced a collaboration with the U.S. Army Medical Materiel Development Activity (USAMMDA). This partnership will provide SLS-002 (intranasal racemic ketamine) for the Department of Defense's (DOD) Military and Veterans Adaptive Platform Clinical Trial (M-PACT). This trial aims to investigate the potential of SLS-002 in treating post-traumatic stress disorder (PTSD) among military personnel and veterans.

The dosing for the SLS-002 cohort is anticipated to start before the end of 2024, marking it as the sole ketamine-based therapy included in this study. The trial is financed by the DOD's Defense Health Agency and is managed by USAMMDA’s Warfighter Readiness, Performance, and Brain Health Project Management Office.

Raj Mehra, Ph.D., CEO of Seelos, highlighted the significance of this development, noting the absence of new PTSD drugs in the past two decades. He emphasized the potential efficacy of ketamine, supported by anecdotal evidence, to alleviate PTSD symptoms. Mehra expressed optimism about SLS-002's intranasal formulation, which may offer rapid benefits with fewer side effects compared to other ketamine administration methods. He conveyed pride in being part of the study and looked forward to the commencement of dosing.

The DOD M-PACT is structured as a Phase II randomized, double-blinded, placebo-controlled study, focusing on the safety, tolerability, and efficacy of several pharmacological treatments in active-duty service members and veterans suffering from PTSD. The adaptive platform design of the trial allows for the random allocation of participants among different treatment cohorts and sharing of control participants to enhance study efficiency. The trial involves a 30-day screening, a 12-week treatment period, and a subsequent 4-week safety follow-up.

Data will be collected to assess changes in PTSD symptom severity using the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) and other relevant clinical endpoints. These endpoints include tracking new or worsening suicidal thoughts or behaviors via changes in the Columbia Suicide Severity Rating Scale (C-SSRS) score. Additionally, the trial will evaluate various biomarkers associated with PTSD, along with the safety and tolerability of the treatments.

SLS-002, an intranasal racemic ketamine, has two investigational new drug applications for treating Acute Suicidal Ideation and Behavior in Major Depressive Disorder and PTSD. Originally developed by Javelin Pharmaceuticals, Inc./Hospira, Inc., SLS-002 has undergone 16 clinical studies involving roughly 500 subjects. Seelos aims to address the unmet need for suicide treatment in the U.S. with SLS-002. Traditional antidepressants used in this context often carry a risk of increased suicidal thoughts and typically take weeks to show therapeutic effects. Data from the Agency for Healthcare Research and Quality indicate over 1,000,000 emergency room visits for suicide attempts in 2019 in the U.S. Experimental studies suggest ketamine's potential as a rapid and effective treatment for refractory depression, suicidality, and PTSD.

The U.S. Army Medical Materiel Development Activity (USAMMDA) is responsible for developing, delivering, and deploying essential drugs, vaccines, biologics, devices, and medical support equipment to safeguard the lives of Warfighters globally. USAMMDA guides the development of medical products for various U.S. military services, the Joint Staff, the Defense Health Agency, and the U.S. Special Operations community, transitioning promising technology from development stages to field deployment and sustainment.

Seelos Therapeutics, Inc. remains committed to advancing novel therapeutics to meet the unaddressed medical needs of patients with central nervous system disorders and rare diseases.