NEW YORK, Jan. 15, 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 patients in its registrational Proof
of Concept study of SLS-002 (intranasal racemic ketamine) for Acute
Suicidal Ideation and Behavior in patients with Major Depressive
Disorder.
"The dosing of the first patients in our study could not come at
a more crucial time as there still remains a high
unmet need for a therapy to address the symptoms of
suicidality," said Raj Mehra Ph.D., Chairman and CEO
of Seelos. "We will continue to train and add trial sites and
look forward to sharing the open-label data from the first 16
patients once dosing, safety follow up, and data analysis have been
completed."
The study is a multicenter, two-part clinical trial, comprised
of an open-label cohort followed by 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 imminent risk of suicide.
The design of the study is as follows:
- The study is comprised of two parts:
-
- Part A is an open-label, non-placebo study of 16 patients
receiving 90mg doses of SLS-002
- Part B 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.
- Part B will commence immediately after the 16th
patient in Part A is dosed.
- Study duration will be 16 days (approximately seven days
inpatient and nine days outpatient), dosed twice weekly (five total
doses), and safety follow up for two weeks.
- The primary endpoint to be evaluated will be the change from
baseline on the:
-
- Montgomery-Åsberg Depression
Rating Scale (MADRS) at 24 hours after first dose.
- The secondary endpoints to be evaluated will be the change from
baseline on the:
-
- Clinical Global Impression of Severity for Suicidal Ideation
and Behavior Scale (CGIS-SI/B) at 24 hours after the first
dose,
- Sheehan-Suicidality Tracking Scale (S-STS) at 24 hours after
the first dose,
- Patient Global Impression of Severity for Suicidal Ideation and
Behavior Scale (PGIS-SI/B) at 24 hours after the first dose,
and
- CGIS-SI/B, S-STS, PGIS-SI/B, and MADRS at Day 16.
The first data readout is expected to be available upon
completion of the study with the first 16 patients in the Part A
open-label portion.
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 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 the potential for ketamine to be a rapid,
effective treatment for refractory depression and suicidality, the
expected timing for the first data readout for the Proof of Concept
study, Seelos' continued training and expectations around the
addition of trial sites for the Proof of Concept study, the design
of the Proof of Concept study, the number of patients to be
enrolled in Part B of the Proof of Concept study, the expected
timing for commencing Part B of the Proof of Concept study, the
expected duration of the Proof of Concept study and the primary and
secondary endpoints to be evaluated in the Proof of Concept study.
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
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
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