– Phase 1B Study Demonstrates the Potential
of GS-6207 to Rapidly Reduce Viral Load After a Single Subcutaneous
Injection –
– Gilead Progresses Long-Acting Therapy
Research Program to Help Address Real-World Challenges for People
Living with HIV –
Gilead Sciences, Inc. (NASDAQ: GILD) today announced data from
clinical and preclinical studies exploring the use of GS-6207, an
investigational, novel, first-in-class inhibitor of HIV-1 capsid
function, as a potential long-acting therapy for people living with
HIV. Results from a Phase 1b proof-of-concept study of a
subcutaneous formulation showed antiviral activity with GS-6207
through the last day of monotherapy, Day 10, with significantly
greater reductions in HIV-1 RNA versus placebo across all treatment
groups (20 to 750 mg; all p<0.0001). These data were presented
at the Conference on Retroviruses and Opportunistic Infections
(CROI) 2020 in Boston.
Additional data presented at CROI provided further information
on the potential utility of GS-6207 that support further
development of the compound. Phase 1 data in healthy volunteers
evaluating an oral tablet formulation found GS-6207 to be generally
safe and well-tolerated with a pharmacokinetic profile supporting
once a week administration without regard to food. Results from a
preclinical study evaluating the impact of resistance mutations on
the in vitro antiviral activity of GS-6207 were also presented. In
this in vitro study, GS-6207 was not affected by mutations at the
gag cleavage sites or by mutations associated with resistance to
the four main classes of antiretroviral agents.
“The antiviral activity and safety profiles demonstrated in
these early preclinical and clinical studies suggest the potential
of GS-6207 as a long-acting treatment for people living with HIV,
including those with multi-class drug resistance,” said Eric S.
Daar, MD, Chief of the Division of HIV Medicine at Harbor-UCLA
Medical Center, Chief of HIV Services at the Lundquist Institute
for Biomedical Innovation, Professor of Medicine at UCLA. “A
long-acting therapy could offer an important option for people
living with HIV who are unable to take a daily pill. These findings
are an encouraging step toward ensuring more treatment options to
fit the diverse needs of people living with HIV.”
“There have been significant advances in HIV therapy over the
past three decades but for some people living with HIV, moving away
from the need to take daily treatment is an important priority,”
said Diana Brainard, MD, Senior Vice President, HIV and Emerging
Viruses, Gilead Sciences. “By creating treatment options that can
maintain virologic suppression regardless of a patient’s adherence
to taking oral medications, our goal is to help people living with
HIV remain virally suppressed for life. These promising early data
are part of Gilead’s commitment to addressing the real-world needs
of people living with HIV.”
GS-6207 is an investigational agent that is being developed as a
component of a long-acting regimen. GS-6207 disrupts HIV capsid, a
multimeric shell that is essential to viral replication, at
multiple stages throughout the viral life cycle. The FDA granted
Breakthrough Therapy Designation for the development of GS-6207 for
the treatment of HIV-1 infection in heavily treatment-experienced
patients with multi-drug resistance in combination with other
antiretroviral drugs. Data from Phase 1 studies that demonstrate
GS-6207’s antiviral activity and its potential for a dosing
interval of up to every six months were presented at the 17th
European AIDS Conference (EACS) in Basel, Switzerland in 2019.
Key abstracts for GS-6207 presented at CROI 2020
include:
Poster 3691: Dose-Response Relationship of Subcutaneous
Long-Acting HIV Capsid Inhibitor GS-6207
This randomized, double-blind Phase 1b dose-response study
evaluated the safety, antiviral activity and pharmacokinetics (PK)
of GS-6207 in people living with HIV. Thirty-nine people living
with HIV were randomized to receive a single subcutaneous dose of
GS-6207 (20, 50, 150, 450, or 750 mg), or placebo. The primary
endpoint was maximum reduction of plasma HIV-1 RNA through
post-dose Day 10.
Results were presented for the 20 to 450 mg dose cohorts; the
750 mg cohort is still enrolling. All participants in the 20 to 450
mg cohorts who received GS-6207 experienced significant reductions
in HIV-1 RNA by Day 10 (p<0.0001) compared to placebo. The
maximum reduction in HIV-1 RNA through Day 10 ranged from 0.8 to
3.0 log10 copies/mL. The predicted maximum HIV-1 RNA reduction
(Emax) was 2.2 log10 copies/mL. GS-6207 was generally safe and well
tolerated. The most common AEs were injection site reactions, which
were mostly mild and transient.
Poster 3670: Pharmacokinetics, Food Effect and Safety of Oral
GS-6207, a Novel HIV-1 Capsid Inhibitor
This randomized, placebo-controlled Phase 1 study evaluated the
safety, PK and food effect of oral GS-6207 in HIV-negative
individuals. In the first cohort, forty participants were
randomized to receive a single dose of oral GS-6207 (50, 300, 900,
or 1800 mg) or placebo. In the second cohort, sixteen participants
received a single dose of GS-6207 (300 mg) after either a high-fat
meal or a lighter meal.
Interim results were presented through 35 days (300 and 900 mg
fasted cohorts) or 8 days (remaining cohorts) post dose. All
individuals completed dosing. GS-6207 was generally safe and well
tolerated, following single oral doses of up to 1800 mg. The most
common AEs were back pain and headache. The half-life of GS-6207
was approximately 12 days and the PK was not affected by high or
low fat meal. These data support the development of GS-6207 as an
oral weekly agent without regard to food.
Poster 4060: Absence of GS-6207 Phenotypic Resistance in HIV
Gag Cleavage Site and Other Mutants
This preclinical study explored the effect of gag cleavage site
mutations, which have emerged with the use of protease inhibitors
(PIs) and maturation inhibitors, on the antiviral activity of
GS-6207. The study also assessed the effect of mutations associated
with resistance to the four main classes of HIV drugs (nucleoside
reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse
transcriptase inhibitors (NNRTIs), PIs and integrase strand
transfer inhibitors (INSTIs)).
The in vitro antiviral activity of GS-6207 was not affected by
mutations at the HIV gag cleavage site or by the presence of
mutations associated with resistance to the four main classes of
HIV drugs. The results support the evaluation of GS-6207 in people
living with HIV with multi-class resistance.
GS-6207 is an investigational compound and is not approved by
the U.S. Food and Drug Administration or any other regulatory
authority. Its safety and efficacy have not been established. There
is no cure for HIV 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 more than 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’s
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.
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-6207, and the possibility
that we are unable to complete one or more of such trials on the
currently anticipated timelines or at all. In addition, it is
possible that Gilead may make a strategic decision to discontinue
development of GS-6207, and as a result, GS-6207 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.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc. or its related companies.
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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version on businesswire.com: https://www.businesswire.com/news/home/20200311005714/en/
Douglas Maffei, PhD, Investors (650) 522-2739 Brian Plummer,
Media (650) 524-7708
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