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
-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.
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.
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 for efficacy and safety data from Part 1 of the Proof of Concept study, the expected timing for the last patient's completion of Part 1 of the Proof of Concept study, the potential for information regarding the efficacy of SLS-002 to provide insights for the treatment of ASIB in patients with MDD, Seelos' expectations around the addition of further trial sites for the Proof of Concept study, commencement of Part 2 of the Proof of Concept study, the design of the Proof of Concept study and the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality. 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 Proof of Concept study of SLS-002, and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, 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.