NEW YORK, March 5, 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, announced
today the completion of enrollment of patients in Part 1 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).
Seelos expects to release key open-label data in the second
quarter of 2021, after analyzing the data received after the last
enrolled patient's completion of Part 1 of the study. Part 1 of the
study has a 16-day treatment period followed by a safety follow-up
period to day 30. The last patient is expected to complete Part 1
of the study on April 1, 2021.
"Our first look at the potential efficacy of SLS-002 in
depressed and imminently suicidal patients should provide valuable
insights in this large unmet need. We look forward to initiating
Part 2 of this study and are continuing to identify more trial
sites," said Raj Mehra Ph.D., Chairman and CEO of Seelos.
The Proof of Concept study is a multicenter,
two-part clinical trial, comprised of an open-label cohort (Part 1)
followed by a randomized, double-blind, placebo-controlled study
(Part 2). Part 1 is an open-label, non-placebo study of 16 patients
receiving standard of care plus 90mg doses of SLS-002, and Part 2
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.
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 or 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 is being
developed to address 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. 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 depression and suicidality.
About 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 Major Depressive Disorder
(MDD) or Post-Traumatic Stress Disorder (PTSD), amyotrophic
lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease,
other psychiatric and movement disorders plus orphan diseases.
For more information, please visit our
website: http://seelostherapeutics.com, the content of which
is not incorporated herein by reference.
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 expected timing for efficacy and safety
data from Part 1 of the Proof of Concept study, the expected timing
for the last patient's completion of Part 1 of the Proof of Concept
study, the potential for information regarding the efficacy of
SLS-002 to provide insights for the treatment of ASIB in patients
with MDD, Seelos' expectations around the addition of further trial
sites for the Proof of Concept study, commencement of Part 2 of the
Proof of Concept study, the design of the Proof of Concept study
and the potential for ketamine to be a rapid, effective treatment
for refractory depression and suicidality. 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
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
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