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-Part 2 of the Registrational Study is a Double-Blind Placebo-Controlled Design Focused on Adult Patients with Major Depression at Imminent Risk of Suicide
-Subjects will be Enrolled in up to 30 Trial Sites in the North America
NEW YORK, July 6, 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, today announced dosing of the first patient in Part 2, the double-blind, placebo-controlled cohort, 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).
"The goal of the development of SLS-002 in treating suicidal patients is to radically change the current standard of care. SLS-002's potential to have a rapid onset of efficacy, as was suggested in Part 1 of our study, aims to show a benefit as quickly as overnight. This could potentially allow for patients to be discharged sooner in the future and treated as an outpatient," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "In addition to displaying our initial results of the efficacy and safety of SLS-002 in patients who were actively suicidal in the Part 1 open label aspect, we have gained invaluable information that we have utilized to further improve the design and execution of Part 2. We have received correspondence from the FDA that Part 2 will serve as a registrational study for the SLS-002 program and we will continue discussions with the FDA on the regulatory pathway going forward."
According to the Centers for Disease Control and Prevention (CDC), suicides and suicide attempts cost the U.S. over $70 billion per year in lifetime medical and work-loss costs alone and the medical community lacks a therapeutic labeled to treat the symptoms of suicidality. Today in the U.S., suicidal patients who present at an Emergency Department are stabilized and can be held in the Emergency Department for several days while waiting for an inpatient psychiatric bed. Currently in the U.S., there is a shortage of over 120,000 inpatient psychiatric beds and the average length of hospitalization for a suicidal patient is 10 days.
Seelos' study is a multicenter, two-part clinical trial, comprised of the Part 1 open-label cohort, which data was released in May 2021, followed by Part 2, a randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the efficacy, safety, and tolerability of repeat doses of SLS-002 (intranasal racemic ketamine) in addition to standard of care on the symptoms of Major Depressive Disorder and suicidality in patients who are assessed to be at an imminent risk of suicide.
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 they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I), followed by pivotal registration studies after meeting with the FDA. 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.
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 expectations regarding enrollment in Seelos' Part 2 of the registrational study focused on adult patients with major depression at imminent risk of suicide (the "Study"), planned additional discussions with the FDA and Seelos' additional Study plans. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing the Study, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Study are not replicated or are materially different from the topline clinical results of Part I of the Study), 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 most recent 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.
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
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