Seelos Therapeutics Announces Final Data from Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002) and Clinical Development Plans

SLS-002 Was Safe and Well Tolerated Across All Doses with Resolution of Expected Group Mean Dissociative Side-Effects That Occurred in the Higher Dose Groups Within One HourNEW YORK, June 23, 2020 (GLOBE NEWSWIRE) — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced final safety data from its Phase I pharmacokinetics/pharmacodynamics (PK/PD) Study of Intranasal Racemic Ketamine (SLS-002) as well as the planned design of a double blind, placebo-controlled Proof of Concept (PoC) study for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD) to begin in the fall of 2020.All doses were safe and well tolerated.There were no new or unique safety signals.There were no serious adverse events.All adverse events (AEs) were transient and were clinically manageable.Mild increase in blood pressure noted in seven subjects – all were transient and resolved without intervention:30 mg – 1 subject60mg – no subjects75mg – 4 subjects90mg – 2 subjectsClinician-Administered Dissociative States Scale (CADSS)Mean values at one hour post dose:30 mg – 0.260 mg (measured at 1.5 hours post dose per protocol) – 0.475mg – 1.190 mg – 1.0No subject had a score > 4 at the two hour timepoint or thereafter.Group mean for each dose group resolved to < 4 by the one hour timepoint and all timepoints thereafter.CADSS is a 23 item scale, where each item is scored 0-4, and the total max score possible is 92. Scores > 4 are judged as clinically meaningful dissociation. As expected, mean increases > 4 were noted at higher doses (75 mg and 90 mg), correlating with peak concentrations (~40 mins). 
 Most common AEs in drug cohorts (>20%) in order of prevalence:Dysgeusia (bad taste)DizzinessFeeling intoxicatedSomnolenceHeadacheOral hypoaesthesia (numbness)Blurred visionEuphoric moodFatigueMost common AEs in placebo (>20%) were dysgeusia and somnolenceKey Highlights for the Design of the Proof of Concept Study
Trial duration will be 16 days (approximately seven days inpatient and nine days outpatient), dosing 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–Åsberg Depression Rating Scale (MADRS) at 24 hours after first dose and the persistence of effect at Day 16 compared to placebo.The key secondary endpoint to be evaluated will be the change from baseline on the Sheehan-Suicidality Tracking Scale (S-STS) Clinically Meaningful Change Measure Total Score at 24 hours after first dose and persistence of effect at Day 16 compared to placeboThe trial will be composed of two stages:Part A of the trial will begin with an open-label, non-placebo study of 16 patients, and  Part B is currently planned to enroll approximately 120 patients to be randomized 1:1 to receive standard of care plus either SLS-002 or an intranasal placebo.Seelos will also host a key opinion leader (KOL) call today at 1 p.m. Eastern time. The call will feature a discussion with Michael E. Thase, MD, professor of psychiatry at the Perelman School of Medicine at the University of Pennsylvania. Dr. Thase is an active clinical investigator whose research focuses on mood disorders and will be available to answer questions at the conclusion of this call.