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- 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 patients in its registrational Proof of Concept study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder.
"The dosing of the first patients in our study could not come at a more crucial time as there still remains a high unmet need for a therapy to address the symptoms of suicidality," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "We will continue to train and add trial sites and look forward to sharing the open-label data from the first 16 patients once dosing, safety follow up, and data analysis have been completed."
The study is a multicenter, two-part clinical trial, comprised of an open-label cohort followed by 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 imminent risk of suicide.
The design of the study is as follows:
- The study is comprised of two parts:
- Part A is an open-label, non-placebo study of 16 patients receiving 90mg doses of SLS-002
- Part B 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.
- Part B will commence immediately after the 16 th patient in Part A is dosed.
- Study duration will be 16 days (approximately seven days inpatient and nine days outpatient), dosed 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.
- The secondary endpoints to be evaluated will be the change from baseline on the:
- Clinical Global Impression of Severity for Suicidal Ideation and Behavior Scale (CGIS-SI/B) at 24 hours after the first dose,
- Sheehan-Suicidality Tracking Scale (S-STS) at 24 hours after the first dose,
- Patient Global Impression of Severity for Suicidal Ideation and Behavior Scale (PGIS-SI/B) at 24 hours after the first dose, and
- CGIS-SI/B, S-STS, PGIS-SI/B, and MADRS at Day 16.
The first data readout is expected to be available upon completion of the study with the first 16 patients in the Part A open-label portion.
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 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 the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality, the expected timing for the first data readout for the Proof of Concept study, Seelos' continued training and expectations around the addition of trial sites for the Proof of Concept study, the design of the Proof of Concept study, the number of patients to be enrolled in Part B of the Proof of Concept study, the expected timing for commencing Part B of the Proof of Concept study, the expected duration of the Proof of Concept study and the primary and secondary endpoints to be evaluated in the Proof of Concept study. 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.
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
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