NEW YORK, March 5, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical firm targeted on the event of therapies for central nervous system issues and uncommon illnesses, introduced in the present day the completion of enrollment of sufferers in Half 1 of its registrational Proof of Idea research of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Conduct (ASIB) in sufferers with Main Depressive Dysfunction (MDD).
Seelos expects to launch key open-label information within the second quarter of 2021, after analyzing the info acquired after the final enrolled affected person’s completion of Half 1 of the research. Half 1 of the research has a 16-day therapy interval adopted by a security follow-up interval to day 30. The final affected person is predicted to finish Half 1 of the research on April 1, 2021.
“Our first take a look at the potential efficacy of SLS-002 in depressed and imminently suicidal sufferers ought to present useful insights on this giant unmet want. We look ahead to initiating Half 2 of this research and are persevering with to establish extra trial websites,” mentioned Raj Mehra Ph.D., Chairman and CEO of Seelos.
The Proof of Idea study is a multicenter, two-part scientific trial, comprised of an open-label cohort (Half 1) adopted by a randomized, double-blind, placebo-controlled research (Half 2). Half 1 is an open-label, non-placebo research of 16 sufferers receiving normal of care plus 90mg doses of SLS-002, and Half 2 goals to enroll roughly 120 sufferers to be randomized 1:1 to obtain normal of care plus both 90mg doses of SLS-002 or an intranasal placebo.
In case you or a liked one are having ideas of suicide, please search fast medical assist, go to your nearest emergency room, or name the National Suicide Prevention Lifeline at 1-800-273-8255.
SLS-002 is intranasal racemic ketamine with two investigational new drug purposes for the therapy of Acute Suicidal Ideation and Conduct in Main Depressive Dysfunction or Submit-Traumatic Stress Dysfunction. SLS-002 was initially derived from a Javelin Prescription drugs, Inc./Hospira, Inc. program with 16 scientific research involving roughly 500 topics. SLS-002 is being developed to handle an unmet want for a remedy to deal with suicidality within the U.S. Historically, anti-depressants have been used on this setting however lots of the current therapies are recognized to contribute to an elevated threat of suicidal ideas in some circumstances, and if they’re efficient, it typically takes weeks for the complete therapeutic impact to be manifested. Primarily based on info gathered from the databases of the Company for Healthcare Analysis and High quality, there have been greater than 1,000,000 visits to emergency rooms for suicide makes an attempt in 2019 within the U.S. alone. Experimental research counsel ketamine has the potential to be a speedy, efficient therapy for despair and suicidality.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical firm targeted on the event and development of novel therapeutics to handle unmet medical wants for the good thing about sufferers with central nervous system (CNS) issues and different uncommon illnesses. The Firm’s strong portfolio consists of a number of late-stage scientific belongings focusing on indications together with Acute Suicidal Ideation and Conduct (ASIB) in Main Depressive Dysfunction (MDD) or Submit-Traumatic Stress Dysfunction (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson’s Illness, different psychiatric and motion issues plus orphan illnesses.
For extra info, please go to our web site: http://seelostherapeutics.com, the content material of which isn’t included herein by reference.
Ahead Wanting Statements
Statements made on this press launch, which aren’t historic in nature, represent forward-looking statements for functions of the secure harbor supplied by the Non-public Securities Litigation Reform Act of 1995. These statements embody, amongst others, these concerning the anticipated timing for efficacy and security information from Half 1 of the Proof of Idea research, the anticipated timing for the final affected person’s completion of Half 1 of the Proof of Idea research, the potential for info concerning the efficacy of SLS-002 to supply insights for the therapy of ASIB in sufferers with MDD, Seelos’ expectations across the addition of additional trial websites for the Proof of Idea research, graduation of Half 2 of the Proof of Idea research, the design of the Proof of Idea research and the potential for ketamine to be a speedy, efficient therapy for refractory despair and suicidality. These statements are based mostly on Seelos’ present expectations and beliefs and are topic to numerous components and uncertainties that might trigger precise outcomes to vary materially from these described within the forward-looking statements. Dangers related to Seelos’ enterprise embody, however aren’t restricted to, the danger of not efficiently executing its preclinical and scientific research, together with the Proof of Idea research of SLS-002, and never gaining advertising approvals for its product candidates, the danger that prior take a look at outcomes might not be replicated in future research and trials, the dangers that scientific research outcomes might not meet all or any endpoints of a scientific research and that any information generated from such research might not help a regulatory submission or approval, the dangers related to the implementation of a brand new enterprise technique, the dangers associated to elevating capital to fund its growth plans and ongoing operations, dangers associated to Seelos’ present inventory worth, dangers associated to the worldwide influence of COVID-19, in addition to different components expressed in Seelos’ periodic filings with the U.S. Securities and Trade Fee, together with its Annual Report on Kind 10-Okay and Quarterly Studies on Kind 10-Q. Though we imagine that the expectations mirrored in our forward-looking statements are cheap, we have no idea whether or not our expectations will show appropriate. You’re cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof, even when subsequently made accessible by us on our web site or in any other case. We don’t undertake any obligation to replace, amend or make clear these forward-looking statements, whether or not on account of new info, future occasions or in any other case, besides as could also be required beneath relevant securities legal guidelines.
Head of Company Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., twelfth Fl
New York, NY 10022
View unique content material to obtain multimedia:http://www.prnewswire.com/news-releases/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-301241165.html
SOURCE Seelos Therapeutics, Inc.