Seelos Therapeutics Reports Q3 2019 Pipeline Update
2019年11月8日 - 9:00PM
Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage
biopharmaceutical company, today released its third quarter
pipeline update. “Seelos continued to make significant progress in
the third quarter on several of our programs”, said Raj Mehra,
Ph.D., Chairman and CEO of Seelos Therapeutics. “We expect
screening and dosing to commence in the phase IIb/III trial in
Sanfilippo syndrome in the US for SLS-005, and in the PK/PD/DDI
studies for SLS-002. As a result, we envision multiple clinical
studies in these two programs next year. Getting these studies
launched in consultation with the FDA, completing a financing, and
ringing the opening bell at Nasdaq have kept us very busy and has
continued to raise awareness of our company.” “IND enabling work
has also begun in SLS-008,” added Tim Whitaker, MD, Head of
R&D. “We plan to study SLS-008 in a pediatric orphan
indication, and we are exploring other potential target indications
as well.” Third Quarter Corporate Highlights
- Seelos received a Notice of Allowance from the United States
Patent and Trademark Office (USPTO) for Seelos' U.S. Patent
Application for SLS-005 (trehalose) for treating Friedreich Ataxia
(FA).
- The company received a grant from Team Sanfilippo Foundation
for funding of studies of SLS-005 in Sanfilippo syndrome type A and
B patients and the separate expanded access study for Sanfilippo
type C and D as well as type A and B patients who do not meet the
trial entry criteria.
- Seelos announced the Investigational New Drug Submission and
Acceptance from FDA for SLS-005 for Mucopolysaccharidosis type III
(Sanfilippo syndrome).
- The Seelos staff and board of directors rang the opening bell
at the Nasdaq Marketsite in Times Square on August 12th.
- The company raised $6.7 million in a registered direct offering
with certain institutional investors.
Update on Pipeline Development
- Seelos is initiating its Phase I studies to further evaluate
the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug
interactions (DDI) of SLS-002 (intranasal racemic ketamine) in
healthy volunteers this quarter and preliminary data from such
studies are expected in Q1 2020.
- Seelos amended its agreement with Vyera Pharmaceuticals which
removes the requirement to conduct a Phase III trial for SLS-002
and converts the one-time cash payment obligation otherwise owed to
Vyera for commencement of the Phase III trial to a series a cash
and stock payments over the next 9 months.
- The company completed a Type C meeting (face to face) with the
FDA to discuss the potential design of a Proof of Concept (PoC)
study for SLS-002. Based on feedback from its Type C meeting with
FDA, Seelos plans to conduct a Phase II PoC study in patients with
Major Depressive Disorder (MDD) at Imminent Risk of Suicide.
- The company is seeking scientific advice from EMA to initiate a
clinical study in Sanfilippo syndrome patients in EU.
- Seelos began IND enabling work this quarter on SLS-008 which it
plans to develop for pediatric esophagitis, an orphan disease and
is exploring other potential target indications.
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, expectations regarding the timeline
for receiving preliminary data from the company’s phase I studies,
plans regarding the study of SLS-008 in a pediatric orphan
indication 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
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