WASHINGTON, April 15, 2020 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and Northwell Health's
research arm, The Feinstein Institutes for Medical Research, today
announced enrollment of the first patient in Vanda's clinical
trial, ODYSSEY VLY-686-3501 (NCT04326426), yesterday at Lenox Hill
Hospital in New York City.
ODYSSEY is a Phase III double-blind placebo-controlled trial
investigating the efficacy and safety of tradipitant, a
neurokinin-1 receptor antagonist, in the treatment of neurogenic
inflammation of the lung secondary to SARS-CoV-2 (COVID-19)
infection. This novel coronavirus is associated with a lower
respiratory tract inflammation that often progresses to Acute
Respiratory Distress Syndrome (ARDS) requiring mechanical
ventilation.
"With the strong leadership and health expertise of Northwell
Health, we expect to be able to accelerate enrollment in this study
and provide results in the coming months," said Mihael H. Polymeropoulos, M.D., President and
Chief Executive Officer of Vanda. "As the mortality rate from
COVID-19 continues to rise in New
York from ARDS, it is critical for clinical research to be
fully embraced by the public, scientific community, health
professionals and the government. We could not think of a better
partner to leverage all of these constituencies than Northwell
Health as we strive to complete this study as soon as possible and
bring potential relief to patients suffering from COVID-19."
The study, led by Dr. Bushra
Mina, M.D., is expected to randomize approximately 300
patients with confirmed COVID-19 pneumonia who receive either
tradipitant or placebo. Vanda, alongside investigators at Lenox
Hill Hospital, will evaluate clinical and laboratory outcomes to
determine the efficacy of tradipitant in treating patients with
COVID-19 pneumonia.
"Our primary focus is to quickly evaluate the impact of
tradipitant in the treatment of patients with neurogenic
inflammation of the lung as a result of COVID-19," said Dr. Mina,
Section Chief of Pulmonary Medicine, Director of Pulmonary &
Critical Care Fellowship at Lenox Hill Hospital, and lead ODYSSEY
study investigator. "The initiation of this clinical trial
represents a significant milestone in our efforts to combat this
health crisis and support our ultimate goal of patient
recovery."
"We are pleased to team up with Vanda," said Kevin J. Tracey, M.D., President and CEO of the
Feinstein Institutes. "Carefully designed clinical trials are an
essential early step to assess risk and benefit of experimental
approaches for COVID-19."
About Tradipitant
Tradipitant is an NK-1R antagonist licensed by Vanda from Eli
Lilly and Company. Tradipitant is currently in clinical development
for gastroparesis, motion sickness as well as atopic
dermatitis.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on
the development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com and follow us on Vanda's Twitter and
LinkedIn.
About the Feinstein Institutes
The Feinstein Institutes for Medical Research is the
research arm of Northwell Health, the largest health care provider
and private employer in New York
State. Home to 50 research labs, 2,500 clinical research
studies and 5,000 researchers and staff, the Feinstein Institutes
raises the standard of medical innovation through its five
institutes of behavioral science, bioelectronic medicine, cancer,
health innovations and outcomes, and molecular medicine. The
Feinstein Institutes make breakthroughs in genetics, oncology,
brain research, mental health, autoimmunity, and are the global
scientific leader in bioelectronic medicine – a new field of
science that has the potential to revolutionize medicine. For more
information about how The Feinstein Institutes produce knowledge to
cure disease, visit feinstein.northwell.edu.
About Northwell Health
Northwell Health is New York
State's largest health care provider and private employer,
with 23 hospitals, about 750 outpatient facilities and more than
13,600 affiliated physicians. Northwell cares for over two million
people annually in the New York
metro area and beyond, thanks to philanthropic support from its
communities. Northwell's 70,000 employees – 16,000-plus nurses and
4,000 employed doctors, including members of Northwell Health
Physician Partners – are working to change health care for the
better. Northwell is making breakthroughs in medicine at the
Feinstein Institutes for Medical Research, and training the next
generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at
Hofstra/Northwell and the Hofstra
Northwell School of Graduate Nursing and Physician Assistant
Studies. For information on Northwell's more than 100 medical
specialties, visit Northwell.edu and follow them @NorthwellHealth
on Facebook, Twitter, Instagram and LinkedIn.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release are "forward-looking
statements" under the securities laws. These forward-looking
statements include, without limitation, statements regarding the
design, enrollment and completion of Vanda's ODYSSEY VLY-686-3501
study, the potential for tradipitant to be a safe and effective
treatment for certain patients with COVID-19 and Vanda's ability to
make tradipitant available to patients for the treatment of
COVID-19. Forward-looking statements are based upon current
expectations that involve risks, changes in circumstances,
assumptions and uncertainties. Important factors that could cause
actual results to differ materially from those reflected in Vanda's
forward-looking statements include, among others: Vanda's ability
to enroll patients for its ODYSSEY VLY-686-3501 study; a failure of
tradipitant to be demonstrably safe and effective in the treatment
of COVID-19; Vanda's ability to obtain FDA approval of tradipitant
for the treatment of COVID-19; and other factors that are set forth
in the "Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of Vanda's
annual report on Form 10-K for the fiscal year ended December 31, 2019, which is on file with the SEC
and available on the SEC's website at www.sec.gov. Additional
factors may be set forth in those sections of Vanda's annual report
on Form 10-Q for the fiscal quarter ended March 31, 2020, to be filed with the SEC in the
second quarter of 2020. In addition to the risks described above
and in Vanda's annual report on Form 10-K and quarterly reports on
Form 10-Q, other unknown or unpredictable factors also could affect
Vanda's results. There can be no assurance that the actual results
or developments anticipated by Vanda will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Therefore, no assurance can
be given that the outcomes stated in such forward-looking
statements and estimates will be achieved. All written and verbal
forward-looking statements attributable to Vanda or any person
acting on its behalf are expressly qualified in their entirety by
the cautionary statements contained or referred to herein. Vanda
cautions investors not to rely too heavily on the forward-looking
statements Vanda makes or that are made on its behalf. The
information in this release is provided only as of the date of this
release, and Vanda undertakes no obligation, and specifically
declines any obligation, to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Media Contact
Feinstein Institutes:
Matthew Libassi
516-465-8325
mlibassi@northwell.edu
Vanda Pharmaceuticals:
AJ Jones II
202-734-3400
aj.jones@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.