Seelos Therapeutics Announces Additional Interim Data from Phase I Studies of Intranasal Racemic Ketamine (SLS-002)
2020年2月26日 - 10:01PM
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 additional interim data from its Phase I
pharmacokinetic/pharmacodynamic (PK/PD) studies of Intranasal
Racemic Ketamine (SLS-002).
Interim data disclosed here includes all 42 subjects from study
SLS-002-101 and 38 out of 62 subjects from study SLS-002-102.
Interim data from both studies has demonstrated that doses of 30mg,
60mg, 75mg and 90mg of SLS-002 have been generally safe and
well-tolerated.
Some of the key highlights of the interim safety findings from
these 80 subjects include:
- There have been no discontinuations due to drug related adverse
events (AEs).
- There have been no serious adverse events (SAEs).
- The vast majority of AEs have been mild or moderate, have been
transient in nature and have not revealed any new or unique safety
signals.
- Only 5 out of 80 subjects have experienced severe AEs that were
transient in nature, consistent with the known profile of the drug,
and all AEs resolved without medical intervention.
“This additional interim data speaks to the safety profile of
SLS-002 that we have seen so far. We have dosed over 80 subjects
across both studies, including doses up to 90mg, and have not seen
any SAEs,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “We
look forward to our Type C meeting with FDA in March for input and
feedback on our proposed adaptive Phase III trial design for
SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients
with Major Depressive Disorder (MDD).”
Additional data from the Phase I studies is expected to be
released late in the first quarter and early in the second quarter
of 2020.
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 interim results of study SLS-002-101 and SLS-002-102,
the safety profile of SLS-002, final data and safety findings from
study SLS-002-101 and study SLS-002-102, the expected timing for
releasing additional data from study SLS-002-101 and study
SLS-002-102, expectations regarding the Type C meeting with the
Food and Drug Administration and expectations regarding Seelos’
proposed Phase III trial design for 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 with
Seelos' business include, but are not limited to, the risk of not
successfully executing its clinical studies, including study
SLS-002-101 or study SLS-002-102, 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, risks related to Seelos’ 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) 293-2136
anthony.marciano@seelostx.comhttps://seelostherapeutics.com/https://twitter.com/seelostxhttps://www.linkedin.com/company/seelos
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