Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from
an ongoing Phase 1 study, which showed that a sustained-delivery
subcutaneous formulation of the company’s investigational, novel
inhibitor of HIV-1 capsid function, lenacapavir (GS-6207),
sustained predicted therapeutic concentrations for at least six
months following a single 900 mg dose. In the study, lenacapavir
was generally well-tolerated, and no serious adverse events were
reported. These data were presented at the 23rd International AIDS
Conference (AIDS 2020: Virtual).
“Long-acting antiretroviral therapy may help address challenges
with treatment adherence and treatment fatigue, providing
additional options to people living with HIV,” said Eric S. Daar,
MD, Chief of the Division of HIV Medicine at the Lundquist
Institute for Biomedical Innovation at Harbor-UCLA Medical Center
and Professor of Medicine at the David Geffen School of Medicine at
UCLA. “The promising safety and pharmacokinetic profiles of
lenacapavir support continued evaluation of an every six-month
dosing interval and further demonstrate the potential for a single
subcutaneous injection of lenacapavir to be part of a long-acting
HIV treatment regimen.”
Lenacapavir is an investigational agent that is being developed
as a component of a long-acting regimen in combination with other
antiretroviral agents. Lenacapavir disrupts HIV capsid, a
multimeric shell that is essential to viral replication, at
multiple stages throughout the viral life cycle. In May 2019, the
FDA granted Breakthrough Therapy Designation for the development of
lenacapavir for the treatment of HIV-1 infection in heavily
treatment-experienced patients with multi-drug resistance in
combination with other antiretroviral drugs.
“There is a compelling unmet need for interventions that can
potentially improve treatment adherence to chronic HIV therapy,
including the development of long-acting formulations, which can be
administered less frequently,” said Diana Brainard, MD, Senior Vice
President and Virology Therapeutic Area Head, Gilead Sciences. “We
hope to make HIV a more manageable part of people’s lives through
continued treatment innovations, including the exploration of
dosing intervals that coincide with regularly scheduled visits with
healthcare providers.”
The safety, efficacy and dosing of lenacapavir are being
evaluated in multiple ongoing clinical studies, and have not yet
been established. Initial data from Phase 1 studies that assessed
the antiviral activity of lenacapavir were presented at the 17th
European AIDS Conference (EACS) in Basel, Switzerland in 2019 and
presented at the Conference on Retroviruses and Opportunistic
Infections (CROI) 2020 in Boston, Mass.
Data presented on lenacapavir at AIDS 2020: Virtual:
Virtual Poster PEB0265: GS-6207 Sustained Delivery
Formulation Supports 6-Month Dosing Interval
In this ongoing, randomized, blinded, placebo-controlled,
single-ascending dose (SAD) Phase 1 study, 30 participants were
randomized (4:1) to receive 300 mg/mL of subcutaneous lenacapavir
(n=eight per cohort) or placebo (n=two per cohort), at 300 mg (1 x
1.0 mL) or 900 mg (3 x 1.0 mL or 2 x 1.5 mL). All study
participants completed dosing, and pharmacokinetic and safety data
were collected through approximately 64 weeks post-dose.
A slow initial release of lenacapavir was observed, and
therapeutic plasma concentrations were sustained for at least six
months following a single 900 mg dose, administered as 3 x 1.0 mL
injections. Similar results were observed following a 900 mg dose
administered as 2 x 1.5 mL injections. Lenacapavir exposures
increased in a generally dose-proportional manner from 300 mg to
900 mg, with maximum concentrations achieved 11 to 14 weeks
post-dose and an apparent half-life of roughly 15 weeks.
Lenacapavir was generally well-tolerated; no serious or grade 3
or 4 adverse events (AEs) related to study drug or leading to study
discontinuation occurred. The most common AEs were injection site
induration (87 percent), pain (63 percent) and erythema (70
percent), all of which were mild. There were no clinically relevant
laboratory abnormalities of grade 3 or higher.
Lenacapavir is an investigational compound and is not approved
by the U.S. Food and Drug Administration or any other regulatory
authority and the safety and efficacy are not yet known. 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.
Gilead is committed to supporting the global health community to
quickly and effectively respond to serious and life-threatening
viral outbreaks worldwide. To that end, we are contributing our
antiviral expertise and resources to help investigate potential
treatments for patients with COVID-19.
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 lenacapavir, 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 lenacapavir, and as a
result, lenacapavir 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 Quarterly Report on Form 10-Q for the quarter
ended March 31, 2020, 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 about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-300
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200704005004/en/
Douglas Maffei, PhD, Investors (650) 522-2739 Brian Plummer,
Media (202) 309-5207
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