Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19
February 26 2020 - 5:00PM
Business Wire
-- U.S. FDA Grants Investigational New Drug
Authorization to Study Remdesivir for the Treatment of COVID-19
--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the
initiation of two Phase 3 clinical studies to evaluate the safety
and efficacy of remdesivir in adults diagnosed with COVID-19 (novel
coronavirus). These randomized, open-label, multicenter studies
will enroll approximately 1,000 patients at medical centers
primarily across Asian countries, as well as other countries
globally with high numbers of diagnosed cases, beginning in March.
The studies will assess two dosing durations of remdesivir,
administered intravenously. The initiation of these studies follows
the U.S. Food and Drug Administration’s (FDA) rapid review and
acceptance of Gilead’s investigational new drug (IND) filing for
remdesivir for the treatment of COVID-19.
The new clinical studies expand the ongoing research into
remdesivir, which includes two clinical trials in China’s Hubei
province led by the China-Japan Friendship Hospital as well as the
recently initiated clinical trial in the United States led by the
National Institute of Allergy and Infectious Diseases (NIAID).
Gilead has donated drug and provided scientific input for these
studies, with results from those in China expected in April.
“Gilead’s primary focus is on rapidly determining the safety and
efficacy of remdesivir as a potential treatment for COVID-19, and
this complementary array of studies helps to give us a more
expansive breadth of data globally on the drug’s profile in a short
amount of time. The speed with which remdesivir has moved into
clinical development for this coronavirus reflects the pressing
need for treatment options and the shared commitment of industry,
governments, global health organizations and healthcare providers
to respond to this public health threat with the highest urgency,”
said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead
Sciences.
The Gilead studies will evaluate two dosing durations of
remdesivir. One study will randomize approximately 400 patients
with severe clinical manifestations of COVID-19 to receive either
five or 10 days of remdesivir. The second study will randomize
approximately 600 patients with moderate clinical manifestations of
disease to receive five or 10 days of remdesivir or standard of
care alone. The primary endpoint of both studies is clinical
improvement, as described below.
Remdesivir is not yet licensed or approved anywhere globally and
has not been demonstrated to be safe or effective for any use.
Working with government agencies, non-governmental organizations
and local regulatory authorities, Gilead is providing remdesivir to
qualified patients with COVID-19 on a compassionate use basis for
emergency treatment outside of ongoing clinical studies.
For more information on Gilead’s response to the coronavirus
outbreak please visit the company’s dedicated page:
https://www.gilead.com/purpose/advancing-global-health/covid-19
About Remdesivir
Remdesivir is an investigational nucleotide analog with
broad-spectrum antiviral activity both in vitro and in vivo in
animal models against multiple emerging viral pathogens including
Ebola, Marburg, MERS and SARS. Remdesivir has been studied in
healthy volunteers and in people with Ebola virus infection.
Individual compassionate use cases are not sufficient to determine
the safety and efficacy of remdesivir in treating COVID-19, which
can only be determined through prospective clinical trials.
About Gilead-Sponsored New Remdesivir
Clinical Trials
The first of two studies will evaluate the safety and efficacy
of both a 5-day and a 10-day dosing regimen of remdesivir
administered intravenously in patients with severe manifestations
of COVID-19. Approximately 400 participants will be randomized in a
1:1 ratio to receive remdesivir 200 mg on day one, followed by
remdesivir 100 mg each day until day 5 or 10, in addition to
standard of care. The primary objective of this study is to
evaluate the effect of remdesivir, as measured by the normalization
of fever and oxygen saturation [T < 36.6 C armpit, < 37.2 C
oral, < 37.8 C rectal; and Sp02 > 94%, sustained for at least
24 hours through Day 14].
The second study will evaluate the safety and efficacy of a
5-day and a 10-day dosing regimen of remdesivir administered
intravenously in patients with moderate manifestations of COVID-19,
compared with standard of care. Approximately 600 participants will
be randomized in a 1:1:1 ratio to receive remdesivir 200 mg on day
one, followed by remdesivir 100 mg in addition to standard of care
each day until day 5 or 10, compared with standard of care alone.
The primary objective of this study is to evaluate the effect of
remdesivir, as measured by the proportion of participants in each
group discharged by day 14.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Forward Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the possibility of unfavorable results from clinical
trials involving remdesivir and the possibility that we may be
unable to complete one or more of such trials in the currently
anticipated timelines or at all. Further, it is possible that
Gilead may make a strategic decision to discontinue development of
remdesivir. As a result, remdesivir may never be successfully
commercialized. All statements other than statements of historical
fact are statements that could be deemed forward-looking
statements. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are
described in detail in Gilead’s Annual Report on Form 10-K for the
year ended December 31, 2019, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200226005955/en/
Sonia Choi, Media (650) 425-5483
Douglas Maffei, Ph.D., Investors (650) 522-2739
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2023 to Apr 2024