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 right now the completion of enrollment of sufferers in Half 1 of its registrational Proof of Idea examine 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 information obtained after the final enrolled affected person’s completion of Half 1 of the examine. Half 1 of the examine has a 16-day remedy interval adopted by a security follow-up interval to day 30. The final affected person is predicted to finish Half 1 of the examine 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 invaluable insights on this giant unmet want. We sit up for initiating Half 2 of this examine 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 examine (Half 2). Half 1 is an open-label, non-placebo examine 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 cherished one are having ideas of suicide, please search speedy 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 functions for the remedy of Acute Suicidal Ideation and Conduct in Main Depressive Dysfunction or Submit-Traumatic Stress Dysfunction. SLS-002 was initially derived from a Javelin Prescribed 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 present therapies are identified 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 data 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 recommend ketamine has the potential to be a fast, efficient remedy 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 contains a number of late-stage scientific property 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 data, please go to our web site: http://seelostherapeutics.com, the content material of which isn’t integrated herein by reference.
Ahead Trying 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 Personal Securities Litigation Reform Act of 1995. These statements embody, amongst others, these relating to the anticipated timing for efficacy and security information from Half 1 of the Proof of Idea examine, the anticipated timing for the final affected person’s completion of Half 1 of the Proof of Idea examine, the potential for data relating to the efficacy of SLS-002 to supply insights for the remedy of ASIB in sufferers with MDD, Seelos’ expectations across the addition of additional trial websites for the Proof of Idea examine, graduation of Half 2 of the Proof of Idea examine, the design of the Proof of Idea examine and the potential for ketamine to be a fast, efficient remedy for refractory despair and suicidality. These statements are based mostly on Seelos’ present expectations and beliefs and are topic to a variety of elements 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 should not restricted to, the danger of not efficiently executing its preclinical and scientific research, together with the Proof of Idea examine of SLS-002, and never gaining advertising and marketing approvals for its product candidates, the danger that prior take a look at outcomes is probably not replicated in future research and trials, the dangers that scientific examine outcomes might not meet all or any endpoints of a scientific examine 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 improvement plans and ongoing operations, dangers associated to Seelos’ present inventory value, dangers associated to the worldwide affect of COVID-19, in addition to different elements expressed in Seelos’ periodic filings with the U.S. Securities and Change Fee, together with its Annual Report on Type 10-Ok and Quarterly Stories on Type 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 right. You might be cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof, even when subsequently made out there 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 because of new data, future occasions or in any other case, besides as could also be required below relevant securities legal guidelines.
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Seelos Therapeutics, Inc. (Nasdaq: SEEL)
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