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

Rhea-AI Summary

Seelos Therapeutics announced final safety data from its Phase I study of SLS-002 (intranasal racemic ketamine) for treating Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD). All doses were safe, with no serious adverse events or new safety signals reported. The treatment is set to enter a Proof of Concept study in Fall 2020, involving 16 initial patients followed by 120 in a double-blind study. The FDA has supported the study design, and Seelos aims to explore SLS-002's potential in broader indications.

Positive

• SLS-002 demonstrated safety with no serious adverse events in the Phase I study.
• FDA feedback confirmed the study design for the upcoming Proof of Concept study for ASIB.
• The trial can lead to potential broader applications in treating MDD.

Negative

• None.

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). 
     
• Most common AEs in drug cohorts (>20%) in order of prevalence:
  • Dysgeusia (bad taste)
  • Dizziness
  • Feeling intoxicated
  • Somnolence
  • Headache
  • Oral hypoaesthesia (numbness)
  • Blurred vision
  • Euphoric mood
  • Fatigue
• Most common AEs in placebo (>20%) were dysgeusia and somnolence

Key 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 placebo
• The 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.

The details of the call are provided below:

Dial-in and Webcast Information
Domestic: 1-877-407-0789
International: 1-201-689-8562
Conference ID: 13704973
Webcast: Click Here for Webcast
               
About SLS-002

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. SLS-002 addresses an unmet need for a therapy to treat suicidality in the U.S. 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 and when 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), expected to be rapidly followed by pivotal registration studies after meeting with the FDA. We believe there is a large opportunity in the U.S. and European markets for products in this space. 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.

About Michael E. Thase, MD

Michael E. Thase, MD, joined the faculty of the Perelman School of Medicine at the University of Pennsylvania in 2007 as Professor of Psychiatry after more than 27 years at the University of Pittsburgh Medical Center and the Western Psychiatric Institute and Clinic where he directed the Depression Treatment and Research Program from its inception in 1987. Dr. Thase obtained his medical degree at the Ohio State University in 1979. He served as an intern, resident, and fellow at the Western Psychiatric Institute and Clinic before joining the University of Pittsburgh School of Medicine in 1983 as an assistant professor of psychiatry.

A fellow of the American Psychiatric Association, Dr. Thase has received numerous honors in his field, including the Marie Eldredge Award from the American Psychiatric Association. He is also a member of many professional and scientific societies, including the American Medical Association, the American College of Neuropsychopharmacology, and the Society for Psychotherapy Research. He has co-authored more than 340 scientific articles and book chapters, as well as seven books. His published articles are featured in various journals, including Archives of General Psychiatry, the American Journal of Psychiatry, and the British Journal of Psychiatry. He is the editor-in-chief of Psychopharmacology Bulletin. A consultant and lecturer, Dr. Thase remains active in the community by giving numerous presentations at state hospitals. He also presents seminars for community hospitals and the Office of Education and Regional Programming.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.

Forward-Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the expected timing to begin the Proof of Concept (PoC) study of SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD), the proposed design of the PoC study, the number of patients to be enrolled in the PoC study, the expected duration of the PoC study, the primary and secondary endpoints to be evaluated in the PoC study and Seelos’ ability to evaluate SLS-002 in indications beyond ASIB, such as first line MDD. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including the proposed PoC Study of SLS-002, and not gaining marketing approvals for its product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

FAQ

What is the purpose of the SLS-002 clinical study?

The SLS-002 clinical study aims to evaluate the safety and efficacy of intranasal racemic ketamine for treating Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

When is the Proof of Concept study for SLS-002 scheduled to begin?

The Proof of Concept study for SLS-002 is scheduled to begin in Fall 2020.

What were the results of the Phase I study for SLS-002?

The Phase I study results indicated that all doses of SLS-002 were safe and well tolerated, with no serious adverse events or new safety signals reported.

How many patients will be involved in the Proof of Concept study for SLS-002?

The Proof of Concept study will initially involve 16 patients in an open-label study, followed by approximately 120 patients in a double-blind study.

What are the primary endpoints of the SLS-002 study?

The primary endpoint will be the change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS) at 24 hours after the first dose and the persistence of effect at Day 16 compared to placebo.