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.
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 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.
Contact Information:
Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
View original content to download
multimedia:https://www.prnewswire.com/news-releases/seelos-therapeutics-doses-first-patient-in-part-2-of-a-registrational-study-of-sls-002-intranasal-racemic-ketamine-for-acute-suicidal-ideation-and-behavior-in-patients-with-major-depressive-disorder-301325220.html
SOURCE Seelos Therapeutics, Inc.