Seelos Therapeutics Announces Dosing of Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002)
2019年11月28日 - 1:00AM
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 Pharmacokinetic
(PK) and Pharmacodynamic (PD) profile study, SLS-002-102.
SLS-002-102 is a two-part, randomized, double-blind,
placebo-controlled, parallel and crossover study of intranasal and
intravenous ketamine which plans to enroll 62 healthy
volunteers.
- 48 subjects in Part A (parallel) will be randomized into four
arms to receive either 30mg, 75mg, 90mg of SLS-002 or placebo over
13 days.
- 14 subjects in Part B (crossover) will be randomized into three
arms; 60mg of IV ketamine followed by 60mg SLS-002, 60mg SLS-002
followed by 60mg of IV ketamine, or placebo over 25 days.
"This study should help clarify SLS-002's safety and
tolerability across multiple intranasal doses, as well help to
identify and understand any pharmacokinetic or pharmacodynamic
differences compared with IV ketamine. This information will assist
us in confirming the dosing strategy for the planned proof of
concept study in patients with MDD suffering from ASIB,” said Raj
Mehra, Ph.D., Chairman and CEO of Seelos Therapeutics. 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 Proof of Concept (PoC) study of Acute Suicidal Ideation
and Behavior (ASIB) in patients with Major Depressive Disorder
(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 our
expectations regarding the scope of SLS-002-102, the expected
timing for receiving preliminary data from SLS-002-102 and
expectations regarding the results of SLS-002-102, as well as the
company’s planned phase II study in patients with MDD suffering
from ASIB. These statements are based on the company’s 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, including
SLS-002-102, and not gaining marketing approvals for our product
candidates, the risks associated with the implementation of a new
business strategy, the risks related to raising capital to fund our
development plans and ongoing operations, risks related to our
current stock price, 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