Gilead Announces Latest Data in Ongoing HIV Cure Research Program
July 23 2019 - 4:00PM
Business Wire
– New Studies Evaluate Agents with Potential
Role in Eliminating HIV Viral Reservoir –
Gilead Sciences, Inc. (NASDAQ: GILD) today presented results
from two studies of investigational toll-like receptor 7 (TLR7)
agonists as part of an HIV cure research program. The Phase 1 and
preclinical study results demonstrate that the TLR7 agonists
vesatolimod (GS-9620) and GS-986 can induce immune activation and
follow earlier preclinical research suggesting that TLR7 agonists
can potentially lead to viral remission, as part of combination
regimens. The HIV viral reservoir is present even in virologically
suppressed individuals and its elimination is regarded as a main
obstacle to achieving a cure. The data were presented at the 10th
International AIDS Society Conference on HIV Science (IAS 2019)
being held in Mexico City.
“While treatments have improved dramatically, people living with
HIV still face a lifetime of therapy and potential complications.
That reality drives our ongoing pursuit of a cure for HIV,” said
Diana Brainard, MD, Senior Vice President, HIV and Emerging
Viruses, Gilead Sciences. “These findings demonstrate that TLR7
agonists have a potential role to play in scalable strategies for
achieving sustained viral remission in humans, and we will continue
to evaluate these agents as part of investigational curative
regimens.”
Studies on TLR7 agonists presented at IAS include:
Oral presentation WEAA0304: Vesatolimod (GS-9620) is safe and
pharmacodynamically active in HIV-infected individuals
This double-blind, placebo-controlled Phase 1 clinical study
enrolled 48 people living with HIV on antiretroviral therapy. The
median age of the participants in this study was 47 years (43 were
male), with a median of 8.1 years of therapy. In the study, 36
participants received escalating doses of vesatolimod (1-12 mg) and
12 received placebo every other week. Vesatolimod at higher doses
stimulated a range of immune responses. Vesatolimod was
well-tolerated at all doses, with no drug-related Grade 3 or 4
adverse events, no related serious adverse events and no adverse
events leading to study drug discontinuation. Study drug-related
adverse events including mild, transient flu-like symptoms were
observed in 9 of 36 participants at doses of 2 mg and higher,
consistent with previous trials. These symptoms resolved within one
day and did not occur with each dose.
“This study demonstrates that vesatolimod can be administered to
people living with HIV at doses that may have immune effect and are
well-tolerated. The results support studies into the potential role
of vesatolimod as part of combination regimens aimed at achieving
ART-free control of HIV,” said Sharon A. Riddler, MD, Director of
Clinical Research in the Infectious Diseases Division, University
of Pittsburgh School of Medicine, one of the study principal
investigators.
Oral presentation WEAA0105: Oral TLR7 agonist administration
induces an immunostimulatory response in SIV-infected
ART-suppressed infant rhesus macaques
This preclinical study evaluated the oral administration of
GS-986 in two simian immunodeficiency virus (SIV)-infected,
virologically suppressed rhesus macaques. At seven months of age,
both macaques were administered 0.1 mg of GS-986 orally. Four weeks
later, a second 0.3 mg dose was administered, and in both instances
blood count, viral loads, cytokine concentrations and immune
response were monitored. At both the 0.1 mg and 0.3 mg dose levels,
GS-986 induced immune system activation with observed increases in
peripheral plasma cytokines/chemokines and activation of immune
cells. GS-986 was well-tolerated with normal complete blood count
and maintenance of viral suppression.
These results add new information to the existing preclinical
data on GS-986 for the potential future application of an oral TLR7
agonist in people living with HIV.
Vesatolimod and GS-986 are investigational compounds and are not
approved by the U.S. Food and Drug Administration or any other
regulatory authority. Their safety and efficacy have not been
established.
There is no cure for HIV infection or AIDS.
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 nearly 30 years, Gilead has been a leading innovator in the
field of HIV, driving advances in treatment, prevention, testing
and linkage to care, and cure research. Today, it is estimated that
more than 12 million people living with HIV globally receive
antiretroviral therapy provided by Gilead or one of the company’s
manufacturing partners.
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 ongoing and
additional clinical trials involving GS-9620 and GS-986. 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 Quarterly Report on Form 10-Q for the quarter
ended March 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.
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