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– Findings Support Continued Investigation of Inhibitor Class as
Part of a Long-Acting Antiretroviral HIV Treatment Strategy –
SEATTLE--(BUSINESS WIRE)--Feb. 13, 2017--
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
“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.
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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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792orMediaRyan