SEELOS THERAPEUTICS, INC. Seelos Therapeutics, Inc. announced that it has dosed the first patients in an ethnobridging study in healthy adult Japanese and non-Asian subjects to compare the safety and pharmacokinetic profiles of SLS-002 (intranasal racemic ketamine). Seelos consulted and received endorsement from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and from the U.S. Food and Drug Administration (FDA) to conduct this Phase I ethnobridging study. Study SLS-002-103 will measure elements such as dosage and administration, sample size, inclusion and exclusion criteria, endpoints, and blood sampling.
Seelos expects that data from this study will help inform inclusion of Japanese subjects in the design of a future global trial in patients with major depressive disorder (MDD) at imminent risk of suicide. SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects.
Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 includes two parallel healthy volunteer studies (Phase I), followed by pivotal registration studies after meeting with the FDA.
Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.
