Seelos Therapeutics, Inc. announced dosing of the first patients in its registrational Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder. The study is a multicenter, two-part clinical trial, comprised of an open-label cohort followed by a randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the efficacy, safety, and tolerability of repeat doses of SLS-002 (intranasal racemic ketamine) in addition to standard of care on the symptoms of Major Depressive Disorder and suicidality in patients who are assessed to be at imminent risk of suicide. The design of the study is as follows: The study is comprised of two parts: Part A is an open-label, non-placebo study of 16 patients receiving 90mg doses of SLS-002. Part B aims to enroll approximately 120 patients to be randomized 1:1 to receive standard of care plus either 90mg doses of SLS-002 or an intranasal placebo. Part B will commence immediately after the 16th patient in Part A is dosed. Study duration will be 16 days (approximately seven days inpatient and nine days outpatient), dosed twice weekly (five total doses), and safety follow up for two weeks. The primary endpoint to be evaluated will be the change from baseline on the: Montgomery- .sberg Depression Rating Scale (MADRS) at 24 hours after first dose. The secondary endpoints to be evaluated will be the change from baseline on the: Clinical Global Impression of Severity for Suicidal Ideation and Behavior Scale (CGIS-SI/B) at 24 hours after the first dose, Sheehan-Suicidality Tracking Scale (S-STS) at 24 hours after the first dose, Patient Global Impression of Severity for Suicidal Ideation and Behavior Scale (PGIS-SI/B) at 24 hours after the first dose, and CGIS-SI/B, S-STS, PGIS-SI/B, and MADRS at Day 16. The first data readout is expected to be available upon completion of the study with the first 16 patients in the Part A open-label portion.