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>>> Seelos Therapeutics Announces Completion of Open-Label Patient Enrollment of Proof of Concept Study of SLS-002 (Intranasal Racemic Ketamine) for Acute Suicidal Ideation and Behavior in Patients with Major Depressive Disorder


Yahoo Finance

March 5, 2021


https://finance.yahoo.com/news/seelos-therapeutics-announces-completion-open-140000932.html


-Open-Label Efficacy and Safety Data of Imminently Suicidal Patients Dosed with SLS-002 Expected in the Second Quarter of 2021


NEW YORK, March 5, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today the completion of enrollment of patients in Part 1 of its registrational Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).

Seelos expects to release key open-label data in the second quarter of 2021, after analyzing the data received after the last enrolled patient's completion of Part 1 of the study. Part 1 of the study has a 16-day treatment period followed by a safety follow-up period to day 30. The last patient is expected to complete Part 1 of the study on April 1, 2021.

"Our first look at the potential efficacy of SLS-002 in depressed and imminently suicidal patients should provide valuable insights in this large unmet need. We look forward to initiating Part 2 of this study and are continuing to identify more trial sites," said Raj Mehra Ph.D., Chairman and CEO of Seelos.

The Proof of Concept study is a multicenter, two-part clinical trial, comprised of an open-label cohort (Part 1) followed by a randomized, double-blind, placebo-controlled study (Part 2). Part 1 is an open-label, non-placebo study of 16 patients receiving standard of care plus 90mg doses of SLS-002, and Part 2 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.

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

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 or 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 is being developed to address 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 they are effective, it often takes weeks for the full therapeutic effect to be manifested. 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 depression and suicidality.

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), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases.

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