NEW YORK, Jan. 6, 2021 /PRNewswire/ -- 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 its year end 2020
business update.
"This past year marked the most significant 12 months in Seelos
Therapeutics' history despite being an otherwise challenging year
due to the COVID-19 pandemic. We completed our safety trial
for the intranasal ketamine program and began opening centers for
our pivotal trial for Acute Suicidal Ideation and Behavior in
patients with major depressive disorder. The trehalose program's
pivotal study in ALS was accepted into the HEALEY ALS Platform
Trial at Harvard and we began our first
in vivo studies of SLS-004 and SLS-007, our gene therapy
Parkinson's programs. Seelos received additional patents around the
world, orphan drug designations in the US and Europe for various programs plus a Rare
Pediatric Disease Designation for SLS-005," remarked Raj Mehra
Ph.D., Chairman and CEO of Seelos. "We look forward to 2021 as
we embark on clinical studies in two unmet needs, namely imminent
suicidality and ALS. We have expanded the Seelos team by adding
several experienced industry veterans as full-time Seelos employees
to efficiently execute clinical and preclinical programs."
Seelos Team Update
Over the past six months, Seelos expanded its team with the
hiring of four full-time employees and the addition of a consultant
to aid in the development of key programs.
In addition, Tim Whitaker, MD
will now serve as Chief Medical Officer (CMO) for Seelos, formerly
serving as Head of Research and Development, and Warren W. Wasiewski, M.D., F.A.A.P. will now
serve as Senior Neuro Advisor.
Jessica Kardish, Kimberly Farrand, Lucas
Pilipski and Manira
Rayamajhi, have all accepted full-time positions at Seelos
as follows:
- Jessica Kardish joined Seelos in
January 2021 as Seelos' VP, Clinical
Development and Operations. Ms. Kardish has over 25 years of drug
development and operations experience in mid-size and small pharma
companies, primarily in CNS and rare disease spaces. During her 11
years at Shire Pharmaceuticals, Ms. Kardish had a successful track
record which included five global regulatory approvals. She holds a
Bachelor of Science from Dickinson
College and a Master's in Public Health from The
Johns Hopkins University.
- Kimberly Farrand joined Seelos
in July 2020 as Seelos' Senior
Director, Clinical Development and Operations. Ms. Farrand
possesses over 20 years of experience in the industry and spent
over 17 years at Shire Pharmaceuticals prior to its acquisition by
Takeda Pharmaceutical Company. She holds a Bachelor of Science in
Chemistry from Penn State and a
Master's in Public Health in Epidemiology from The George Washington University.
- Lucas Pilipski joined Seelos in
December 2020 as Seelos' Executive
Director of Clinical Operations. Mr. Pilipski has over 17 years of
industry experience and spent over four years at Sanofi S.A. and
eight years at Shire Pharmaceuticals. He holds a Bachelor of
Science in Biology from William Patterson University and a Master's
of Science in Biology from Villanova
University.
- Manira Rayamajhi, Ph.D.,
joined Seelos in July 2020 as Seelos'
Associate Director, Global Regulatory Affairs. She has 10 years of
experience spanning multiple therapeutic areas and in all phases of
development. She was a Postdoctoral Research Fellow at the
University of North Carolina at Chapel
Hill for 5 years and previously worked at Carmago
Pharmaceutical Services, Syneos Health, and MMS Holdings in various
capacities. Dr. Rayamajhi holds a Bachelor of Arts in Biology and
Chemistry from Wesleyan College and a
Ph.D. in Immunology from the University of
Colorado Denver.
David M. Biondi, DO, FAAN has
also joined Seelos as a consultant with an extensive background in
medical practices and the pharmaceutical industry. Dr. Biondi
served as a neurologist in the United
States Navy and later in community and academic practice
settings. He held medical affairs and clinical development roles at
Janssen Pharmaceuticals, Johnson & Johnson, and Alder
Biopharmaceuticals. He most recently served as Executive Director
for Clinical Programs at Cohen Veterans Bioscience and currently
sits on their Board of Directors. Dr. Biondi holds a Bachelor
of Science in Pharmacy from Long Island
University, a Doctor of Osteopathic Medicine from The
University of New England and served
his Neurology Residency at the US National Naval Medical Center in
Bethesda, MD.
Seelos Business Update
In 2020, Seelos Therapeutics achieved several major milestones
and continued to make progress on its multiple clinical stage
development programs.
SLS-002 (intranasal racemic ketamine)
- In March, completed a Type C meeting with the FDA for advice on
a regulatory pathway and two-part pivotal trial design
- In the second quarter, released final safety data of Phase I
pharmacokinetics/pharmacodynamics study showing a safe and well
tolerated side effect profile at the highest dose levels
- In the fourth quarter, initiated trial sites
in screening and dosing patients for the open-label 16 patient
Part A study
- Received a new patent in Japan for anxiety due to phobic
disorders
SLS-005 (IV trehalose)
- In the third quarter, received a "may proceed" notice
from FDA to initiate pivotal Phase IIb/III trial in ALS
- In December, SLS-005 was selected for the HEALEY ALS Platform
Trial led by Harvard Medical School at
Massachusetts General
Hospital
- SLS-005 received US Orphan Drug Designation (ODD) in ALS and
Sanfilippo syndrome and European ODD for Sanfilippo
syndrome
- Granted Rare Pediatric Disease Designation for SLS-005 in
Sanfilippo syndrome
- Received multiple patents in US and Israel
SLS-004 and SLS-007 (Parkinson's disease gene therapy
programs)
- In the second quarter, initiated preclinical in vivo
studies of both SLS-004 and SLS-007 in
Parkinson's disease
- In September, announced a sponsored research agreement with
Duke University for gene therapy
studies of SLS-004
- In October, received a patent covering composition of matter
for SLS-007
Upcoming Catalysts
SLS-002 (intranasal racemic ketamine)
- Potentially pivotal Proof of Concept study commenced in
December, and Seelos is continuing to open trial sites for
screening and dosing
- First data readout upon completion of the first 16 patients in
the Part A open-label portion
SLS-005 (IV trehalose)
- Pivotal Phase IIb/III trial in ALS to begin in the first
half of 2021 in the HEALEY ALS Platform Trial
SLS-004 and SLS-007 (Parkinson's disease gene therapy
programs)
- SLS-007 Preclinical data on delivery and target engagement
expected in Q1 2021
- SLS-004 Preclinical data expected mid-2021
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 Seelos' ability to complete clinical studies for product
candidates for imminent suicidality and ALS, Seelos' ability to
efficiently execute clinical and pre-clinical programs, the hiring
of certain employees and consultants, including their ability to
aid in the development of key programs, the safety profile of
SLS-002, the final safety data of SLS-002, the potential pivotal
proof of concept study for SLS-002, opening additional trial sites
for screening and dosing for the pivotal proof of concept study for
SLS-002, the commencement of the pivotal Phase IIb/III trial of
SLS-005 for ALS in the HEALEY ALS Platform Trial, the expected
timing for preclinical data regarding the delivery and target
engagement of SLS-007, and the expected timing for preclinical data
for SLS-004. 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 preclinical and clinical
studies and not gaining marketing approvals for its product
candidates, the risk that prior test results may not be replicated
in future studies and trials, the risks that clinical study results
may not meet any or all endpoints of a clinical study and that any
data generated from such studies may not support a regulatory
submission or approval, 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, risks
related to the global impact of COVID-19, 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.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
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SOURCE Seelos Therapeutics, Inc.