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 Hour

Food and Drug Administration Feedback from Type C Meeting Supported the Design of a 16 Day Study for Acute Suicidal Ideation and Behavior (ASIB) in Patients with Major Depressive Disorder (MDD); Study to Begin in Fall 2020

Seelos to Host Key Opinion Leader Call Today at 1 p.m. Eastern Time

NEW 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.

Seelos is planning to initiate this PoC study in two parts: Part A is an open-label study of 16 patients, and will be followed by Part B which is a double blind, placebo-controlled study of approximately 120 patients.

“Today’s announcement marks the most significant event so far in Seelos’ brief history,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “It is heartening to see that all intranasal doses were judged to be generally safe and well tolerated, and the resolution of dissociative side-effect among all doses by the one hour timepoint for this group mean affords that this therapy is truly differentiated, which enables Seelos to evaluate SLS-002 in indications beyond ASIB, such as first line MDD.”

Key Highlights from the Phase I PK/PD Safety Data (total enrollment 62 subjects)

• 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 subject
  • 60mg – no subjects
  • 75mg – 4 subjects
  • 90mg – 2 subjects
• Clinician-Administered Dissociative States Scale (CADSS)
  • Mean values at one hour post dose:
    • 30 mg – 0.2
    • 60 mg (measured at 1.5 hours post dose per protocol) – 0.4
    • 75mg – 1.1
    • 90 mg – 1.0
  • No 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).