Gilead Announces Findings from New Preclinical Study Evaluating Novel Class of HIV Capsid Inhibitors
February 13 2017 - 6:45PM
Business Wire
– Findings Support Continued Investigation
of Inhibitor Class as Part of a Long-Acting Antiretroviral HIV
Treatment Strategy –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced findings
from a preclinical study evaluating HIV capsid inhibitors (CAIs)
for potential use as a long-acting antiretroviral (ARV) treatment.
The study identified novel HIV-1 capsid inhibitors with highly
potent antiviral activity and a favorable resistance profile to
existing ARVs in vitro. The data are being presented in an oral
session (Session O-4) at the 2017 Conference on Retroviruses and
Opportunistic Infections (CROI) in Seattle.
“Capsid inhibition is a previously unexplored target for
antiviral therapy and we are pleased to share these preclinical
results showing the potential role of this class of therapy as a
novel, long-acting injectable for HIV treatment and prevention in
the future,” said Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “This research represents Gilead’s ongoing
commitment to innovation in the field of HIV and our work to
advance treatments for people living with the disease.”
The preclinical study found that GS-CA1, an exemplified member
of a novel class of CAIs, is a highly potent inhibitor of HIV-1
replication in human peripheral blood mononuclear cells (PBMCs)
(EC50 = 140 pM) and displays similar potency against multiple HIV-1
clinical isolates from all major clades. The study also found that
the identified CAIs bind to a broadly conserved site at the
interface of two adjacent monomers within a capsid hexamer and
accelerate capsid assembly in vitro.
The identified CAIs maintained full activity in vitro against
HIV-1 mutants resistant to licensed antiretrovirals (ARVs) and
selected for HIV capsid variants L56I, M66I, Q67H or N74D with an
attenuated in vitro replication phenotype. Preclinical mechanistic
studies revealed a dual mode of action targeting both the
late-stage virion maturation and post-entry capsid functions.
GS-CA1 showed high in vitro metabolic stability and displayed an
extended-release preclinical pharmacokinetic profile following a
single subcutaneous administration that maintained target plasma
concentrations for over 10 weeks.
Gilead plans to evaluate a selected development candidate in
Investigational New Drug (IND)-enabling toxicology studies and
begin Phase 1 clinical trials in 2018.
GS-CA1 is an investigational therapy and has not been determined
to be safe or efficacious.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
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. In
addition, we may be unable to begin Phase 1 clinical trials in the
currently anticipated timelines. In addition, we may observe
unfavorable results from additional studies involving proprietary
CAIs, including GS-CA1. In addition, Gilead may make a strategic
decision to discontinue development of GS-CA1 and other proprietary
investigational CAIs if, for example, Gilead believes
commercialization will be difficult relative to other opportunities
in its pipeline. As a result, GS-CA1 and other proprietary
investigational CAIs may never be successfully commercialized.
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 Quarterly Report on Form 10-Q for
the quarter ended September 30, 2016, 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.
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Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792orMediaRyan
McKeel, 650-377-3548
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