Seelos Therapeutics Announces Initial Dosing of Phase I DDI Study of Intranasal Racemic Ketamine (SLS-002)
2019年11月20日 - 11:00PM
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 subjects in a Phase I Drug-Drug
Interaction (DDI) study, SLS-002-101.
SLS-002-101 is a single-center, open-label study of SLS-002
dosed in combination with two commonly prescribed antidepressants.
This study plans to enroll 48 healthy volunteers, studied over 14
days, randomized into two treatment arms and dosed with a
combination of SLS-002 and either, venlafaxine ER or sertraline.
The primary objective of this study is to evaluate the
pharmacokinetic (PK) profile, DDI, and safety measures of SLS-002.
“The initial dosing of SLS-002 is a very significant event for
Seelos and in the development of intranasal racemic ketamine. We
hope to initially demonstrate that SLS-002 can be safely dosed in
combination with subjects’ current use of two commonly prescribed
antidepressants,” said Raj Mehra, Ph.D., Chairman and CEO of
Seelos. “The initiation of the DDI study will be closely followed
by an additional Phase I study measuring PK, pharmacodynamics (PD),
and safety of multiple, repeated, single doses of SLS-002 as well
as IV ketamine.”
Preliminary data from this study is expected in the first
quarter of 2020.
Upon successful completion of the Phase I studies, Seelos plans
to conduct a Phase II Proof of Concept (PoC) study of Acute
Suicidal Ideation and Behavior (ASIB) in patients with Major
Depressive Disorder (MDD).
Seelos recently announced that the FDA has granted Fast Track
designation for SLS-002 for the treatment of ASIB in patients with
MDD.
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 enrollment size, duration, primary
objectives and results of the phase I study of SLS-002 to evaluate
the PK, PD and DDI, expectations regarding the timing for receiving
data from the phase I study of SLS-002, the initiation and
objectives of an additional phase I study of SLS-002 and IV
ketamine to measure PK, PD and the safety of multiple, repeated,
single doses of SLS-002 and IV ketamine and the phase II proof of
concept study and future clinical development of SLS-002 and the
treatment of ASIB in patients with MDD. 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 clinical
studies and not gaining marketing approvals for its product
candidates, 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, 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)
293-2136anthony.marciano@seelostx.comhttps://seelostherapeutics.com/https://twitter.com/seelostxhttps://www.linkedin.com/company/seelos
Seelos Therapeutics (NASDAQ:SEEL)
過去 株価チャート
から 6 2024 まで 7 2024
Seelos Therapeutics (NASDAQ:SEEL)
過去 株価チャート
から 7 2023 まで 7 2024