Seelos Therapeutics Reports Q2 2019 Pipeline Update
2019年8月1日 - 10:00PM
Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage
biopharmaceutical company, today released its second quarter
pipeline update. “We have made tremendous progress on multiple
programs,” emphasized Raj Mehra, Ph.D., Chairman and CEO of Seelos
Therapeutics, “progressing with the initiation of a potentially
pivotal study for SLS-005 in a broad spectrum of Sanfilippo
syndrome A and B patients and including the C and D type patients
in an expanded access program is a great achievement in an
indication with paucity of therapeutic choices. We will further
develop SLS-005 in other neurological indications such as
oculopharyngeal muscular dystrophy (OPMD).” “Simultaneously, we are
finalizing the protocol for a proof-of-concept study in
Suicidality/Acute Suicidal Ideation and Behavior in a broader
depression population for SLS-002 in discussions with the FDA,”
added Tim Whitaker, MD, Head of R&D. “We continue to make
preparations to begin the PK/PD and DDI studies in Q3.” “Additional
preclinical studies are underway for SLS-007 to further
characterize the peptides’ potential in targeting alpha-synuclein
pathology in Parkinson’s Disease. This approach is complementary to
our SLS-004 utilizing gene therapy to reduce the expression of
alpha-synuclein.” Dr. Mehra continued, “we have assembled a team of
seasoned pharmaceutical drug developers across all key functions
and provided them with ample resources to execute on our strategic
plans.” Second Quarter Corporate Highlights
- Seelos acquired exclusive worldwide licensing of a gene therapy
program targeting the regulation of the SNCA gene, which encodes
alpha-synuclein expression, from Duke University. The company
plans to study this approach, named SLS-004, initially in
Parkinson's Disease (PD).
- The company announced it had scheduled a Type C meeting (face
to face) with the FDA to take place over the summer to design and
initiate a Proof of Concept study for SLS-002 (intranasal racemic
ketamine) in suicidality.
- Seelos initiated additional in-vitro studies for further
characterization of SLS-007 and is in the process of initiating
proof of concept studies for in-vivo delivery in rodents. This will
set up the target engagement studies in transgenic rodent models of
Parkinson’s Disease.
- Warren W. Wasiewski, M.D., F.A.A.P. joined Seelos as Chief
Scientific Officer and will lead the SLS-005 program in Sanfilippo
syndrome and spearhead the trehalose program in oculopharyngeal
muscular dystrophy (OPMD).
- Seelos (NASDAQ:SEEL) was added to the Russell Microcap®
Index.
Update on Pipeline Development
- SLS-002 (intranasal racemic ketamine) - In line with Seelos’
Investigational New Drug (IND) program, preparations are underway
to initiate its phase I in Q3 2019 to further evaluate the
pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug
interactions (DDI) of SLS-002 in healthy volunteers.
- SLS-005 (trehalose) - In July, Seelos submitted the
Investigational New Drug Application (IND) for an FDA/EMA
open-label phase IIb/III trial in Sanfilippo syndrome type A and B
patients and will 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.
- Seelos announced the receipt of a grant from Team Sanfilippo
Foundation to be used towards funding of the SLS-005 program.
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., 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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