Seelos Therapeutics Provides Update on Pipeline Developments and Corporate Highlights
June 06 2019 - 7:00AM
Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage
biopharmaceutical company provided an update on recent pipeline
developments and corporate highlights.
“Seelos will be meeting with FDA to design and initiate a
Proof-of-Concept (PoC) study in patients with post-traumatic stress
disorder (PTSD) at imminent risk of suicide,” said Raj Mehra, PhD,
Chairman, Founder, and CEO of Seelos. “This study is in addition to
our already scheduled PK/PD and DDI studies.”
Recent Corporate Highlights
- Warren W. Wasiewski, M.D., F.A.A.P. has joined Seelos
Therapeutics, Inc. as Chief Scientific Officer
- Dr. Wasiewski brings over 35 years' of experience to Seelos
including those spent as a practicing physician, focused on
pediatric neurology, as well as his extensive clinical and
regulatory experience at companies involved in the neurology,
pediatric and orphan disease space
- Dr. Wasiewski has worked previously at Alexion Pharmaceuticals,
AstraZeneca LP and Bioblast Pharma Ltd., Inc, among others
Update on Pipeline Development
Seelos will webcast its presentation at the Jefferies 2019
Healthcare Conference at 8am (ET) on Friday, June 7th. Investors
can access this presentation using this link:
http://wsw.com/webcast/jeff118/seel
- SLS-002 (intranasal racemic ketamine)
- Seelos is seeking guidance from the FDA in a scheduled Type C
meeting (face to face) over the summer to design and initiate a PoC
study in patients with Suicidality-PTSD
- This study is in addition to our PK/PD and DDI study that is
scheduled for dosing in healthy volunteers in late
Q3
- The study plans to utilize the Sheehan-Suicidality Tracking
Scale (S-STS) to measure the safety and efficacy of
intranasal racemic ketamine
- In addition to the S-STS, and usual safety measures and scales,
we intend to utilize the following "gold standard" in the
assessment of PTSD: the PTSD Checklist for DSM-5 (PCL-5), the
Clinically Administered PTSD Scale (CAPS) to measure symptoms of
PTSD, and the Montgomery-Åsberg Depression Rating Scale (MADRS) to
stratify and to measure the severity of possible co-morbid
depression symptoms
- SLS-005 (trehalose)
- Dr. Wasiewski will lead our collaboration with Team Sanfilippo
Foundation (TSF), to advance SLS-005 (trehalose) program in
Sanfilippo syndrome patients and will spearhead the trehalose
program in oculopharyngeal muscular dystrophy (OPMD)
- This study has now been expanded to be a combined Phase 2b/3,
multicenter, enriched enrollment, case controlled withdrawal trial
which will determine the safety and tolerability of Trehalose IV in
Sanfilippo A and B patients along with efficacy based on well-known
biomarkers, functional outcomes, neuro-cognitive assessments and
quality of life measurements
- TSF and Seelos previously announced on May 21st the decision to
expand inclusion of Sanfilippo type C and D patients as well as
type A and B patients who do not meet the trial entry criteria into
a separate expanded patient access study
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 disorders. The Company’s robust portfolio
includes several late-stage clinical assets targeting psychiatric
and movement disorders, including orphan diseases. Seelos is based
in New York, New York.
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 our expectations
regarding the expected timing for dosing the first patient with
Sanfilippo Syndrome with Trehalose, expectations regarding the
initiation of a phase I study with intranasal racemic ketamine in
Suicidality-PTSD and expectations regarding proof of concept for
target engagement for peptide-based approach targeting the NACore
in Parkinson’s Disease. 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 preclinical and
clinical studies 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, 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., 14th 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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