Company plans to continue its previously announced potential partnership discussions and expects to proceed to Phase III with SLS-002 in Adults with Major Depressive Disorder (MDD) at Imminent Risk of Suicide

该公司计划继续其先前宣布的潜在合作伙伴关系讨论，并预计在即将面临自杀风险的重度抑郁症（MDD）成年人中使用SLS-002进入第三阶段

NEW YORK, Jan. 22, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ('Seelos'), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the receipt of minutes from its End of Phase II Meeting with the FDA. .

纽约，2024年1月22日/PRNewswire/-Seelos Therapeutics，Inc.（纳斯达克：SEEL）（“Seelos”）是一家专注于开发中枢神经系统疾病和罕见疾病治疗方法的临床阶段生物制药公司，今天宣布收到与FDA第二阶段会议结束的会议记录。。

In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale.

在会议记录中，FDA同意III期试验的主要终点可能是蒙哥马利抑郁量表（MADRS）总分在第16天从基线的变化，而不是在第二阶段SLS-002-201研究中选择的24小时时间点。关键的次要终点可能是自杀量表在24小时时从基线的变化。

This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS (p-value: 0.012) and the 24-hour Sheehan- Suicidality Tracking Scale (S-STS) (p-value: 0.008)..

与FDA的这项协议为Seelos的SLS-002 III期开发提供了进一步的信心，因为II期研究的数据显示，在第16天MADRS（p值：0.012）和24小时Sheehan自杀追踪量表（S-STS）（p值：0.008）上，与安慰剂相比，临床上显着的治疗差异。。

'We are very excited about the potential that SLS-002 has to address the unmet need of acute suicidality. We are working to design one robust Phase III trial that has the potential to demonstrate a statistically persuasive effect utilizing agreed FDA endpoints,' said Raj Mehra, Ph.D., Chairman and Chief Executive Officer of Seelos..

“我们对SLS-002有潜力解决急性自杀未获满足的需求感到非常兴奋。Seelos董事长兼首席执行官拉吉·梅赫拉（RajMehra）博士说，我们正在努力设计一个强大的III期临床试验，该试验有可能利用FDA商定的终点证明具有统计学说服力。。

'We want to thank the FDA for this collaborative discussion and look forward to future discussions on the modifications for the Phase III protocol that align with what SLS-002 previously demonstrated in the Phase II study,' said Tim Whitaker, M.D., Chief Medical Officer of Seelos. 'We also want to again thank all of the study participants and study sites who helped us gather important data in the Phase II study.

Seelos首席医学官蒂姆·惠特克（TimWhitaker）医学博士说：“我们要感谢FDA的这次合作讨论，并期待着未来就第三阶段协议的修改进行讨论，这些修改与SLS-002之前在第二阶段研究中所展示的内容保持一致。”我们还要再次感谢所有研究参与者和研究站点，他们帮助我们在第二阶段研究中收集了重要数据。

This will help us refine the potential Phase III study. We also look forward to participating in the U.S. Department of Defense's (DOD) adaptive platform trial to evaluate treatments for post-traumatic stress disorder (PTSD).'.

这将有助于我们完善潜在的III期研究。我们还期待着参加美国国防部（DOD）自适应平台试验，以评估创伤后应激障碍（PTSD）的治疗方法。

In 2022 there were 49,449 suicides in the U.S. and unfortunately, the medical community still lacks an FDA-approved therapeutic to treat the symptoms of suicidality. According to the Centers for Disease Control and Prevention (CDC), in 2020, suicides and non-fatal self-harm cost the U.S. over $500 billion in medical and work-loss costs, value of statistical life, and quality of life costs.

2022年，美国有49449人自杀，不幸的是，医学界仍然缺乏FDA批准的治疗自杀症状的疗法。根据疾病控制与预防中心（CDC）的数据，2020年，自杀和非致命性自残使美国的医疗和工作损失成本、统计寿命价值和生活质量成本超过5000亿美元。

Suicidal patients who present suicidal ideation and behavior symptoms at an emergency department can be held in the emergency department for several days while awaiting an inpatient psychiatric bed..

在急诊室出现自杀念头和行为症状的自杀患者可以在急诊室等待住院精神病床几天。。

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 Suicide and Crisis Lifeline at 988 or 1-800-273-8255 (TALK).

如果您或您所爱的人有自杀的念头，请立即寻求医疗帮助，前往您最近的急诊室，或致电988或1-800-273-8255（TALK）拨打自杀与危机生命线。

About SLS-002

关于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是鼻内消旋氯胺酮，具有两种研究性新药应用，用于治疗重度抑郁症和创伤后应激障碍中的急性自杀意念和行为。SLS-002最初来源于Javelin Pharmaceuticals，Inc./Hospira，Inc.计划，共有16项临床研究，涉及约500名受试者。

Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002. 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.

Seelos希望解决美国SLS-002治疗自杀的治疗需求未得到满足的问题。传统上，在这种情况下使用抗抑郁药，但已知许多现有的治疗方法在某些情况下会增加自杀念头的风险，如果它们有效，通常需要数周才能显示出完全的治疗效果。

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..

根据从医疗保健研究与质量机构数据库收集的信息，仅在美国，2019年就有超过1000000人因自杀未遂前往急诊室。实验研究表明，氯胺酮有可能成为难治性抑郁症和自杀的快速有效治疗方法。。

About Seelos Therapeutics

关于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 MDD, PTSD, amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease..

Seelos Therapeutics，Inc.是一家临床阶段的生物制药公司，专注于开发和改进新型疗法，以满足中枢神经系统（CNS）疾病和其他罕见疾病患者未满足的医疗需求。该公司强大的投资组合包括针对MDD、PTSD、肌萎缩侧索硬化症（ALS）和脊髓小脑共济失调（SCA）的急性自杀意念和行为（ASIB）等适应症的几个晚期临床资产，以及亨廷顿舞蹈病、阿尔茨海默氏病和帕金森氏病的早期项目。。

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

有关更多信息，请访问我们的网站：http://seelostherapeutics.com，其内容不通过引用并入本文。

Forward Looking Statements

前瞻性声明

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 Phase II study of SLS-002, statements regarding SLS-002's prospects and potential, statements regarding any potential market opportunity for SLS-002, statements regarding any planned meetings and discussions with the FDA, statements regarding any potential partnerships and discussions related thereto, statements regarding the Company's expectations to proceed to a Phase III trial for SLS-002 in adults with MDD and the protocol, trial design and endpoints for any such trial and the Company's participation in the DOD's PTSD platform trial.

本新闻稿中的声明不具有历史性，就1995年《私人证券诉讼改革法案》提供的安全港而言，构成前瞻性声明。这些声明包括关于SLS-002第二阶段研究的声明，关于SLS-002前景和潜力的声明，关于SLS-002潜在市场机会的声明，关于与FDA计划举行的任何会议和讨论的声明，关于任何潜在伙伴关系和相关讨论的声明，关于公司预期在患有MDD的成年人中进行SLS-002 III期试验的声明，以及任何此类试验的方案，试验设计和终点以及公司参与国防部创伤后应激障碍平台试验的声明。

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, not being able to move forward with the development of SLS-002 after the anticipated end of Phase II meeting with the FDA, and not gaining marketing approvals for SLS-002 and/or its other product candidates; the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results from the prior studies of SLS-002 may not be replicated or may be materially different from the results of Part 2 of the Phase II study of SLS-002); the risks that clinical study results may not meet any or all endpoints of a clinical study .

这些声明基于Seelos当前的期望和信念，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与前瞻性声明中描述的结果存在重大差异。与本文所述的Seelos业务和计划相关的风险包括但不限于未能成功执行其临床前和临床研究的风险，在与FDA的第二阶段会议预期结束后无法推进SLS-002的开发，以及无法获得SLS-002和/或其他候选产品的营销批准的风险；先前的临床结果可能无法在未来的研究和试验中复制的风险（包括SLS-002先前研究的结果可能无法复制或可能与SLS-002 II期研究第2部分的结果有实质性差异的风险）；临床研究结果可能不符合临床研究的任何或所有终点的风险。

Contact Information:

联系方式：

Anthony MarcianoChief Communications OfficerSeelos Therapeutics, Inc. (Nasdaq: SEEL)300 Park AvenueNew York, NY 10022(646) 293-2136[email protected]https://seelostherapeutics.com/https://twitter.com/seelostxhttps://www.linkedin.com/company/seelos

Anthony MarcianoChief Communications OfficerSeelos Therapeutics, Inc. (Nasdaq: SEEL)300 Park AvenueNew York, NY 10022(646) 293-2136[email protected]https://seelostherapeutics.com/https://twitter.com/seelostxhttps://www.linkedin.com/company/seelos

Mike Moyer Managing DirectorLifeSci Advisors, LLC250 West 55th St., Suite 3401 New York, NY 10019(617) 308-4306[email protected]

Mike Moyer常务董事Lifesci Advisors，LLC250 West 55th St.，Suite 3401 New York，NY 10019（617）308-4306[受电子邮件保护]

SOURCE Seelos Therapeutics, Inc.

来源：Seelos Therapeutics，Inc。