Gilead Presents Preliminary Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of ...
20 June 2016 - 10:30PM
Business Wire
– Bictegravir Now Being Evaluated in Phase 3
Studies as Part of a Single Tablet HIV Regimen in Combination with
Other Antiretroviral Agents –
Gilead Sciences, Inc. today announced data from four
pre-clinical and Phase 1 studies evaluating bictegravir (GS-9883),
a novel, unboosted, investigational once-daily integrase strand
transfer inhibitor (INSTI). The studies, which examined the
antiviral potency, resistance profile, pharmacokinetics and safety
of bictegravir, were presented this weekend during a poster session
at the American Society of Microbiology (ASM) Microbe 2016
Conference in Boston. Bictegravir is currently in Phase 3 trials as
part of a single tablet regimen in combination with tenofovir
alafenamide (TAF) and emtricitabine (FTC) for the treatment of
HIV-1 infection (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg).
“We are pleased to share initial results from the bictegravir
clinical program, including data from the first Phase 1 human
trial, which provided proof of concept for further evaluation of
bictegravir as part of a single tablet regimen,” said Norbert
Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences.
“Bictegravir represents Gilead’s ongoing efforts to develop new
therapies with the potential to improve upon currently available
treatments and address the unmet needs of people living with
HIV.”
Bictegravir (GS-9883) Data at
ASM
Poster 413: Bictegravir (GS-9883), a Novel HIV-1 Integrase
Strand Transfer Inhibitor (INSTI) with Optimized In Vitro
Resistance Profile
- The study examined the in vitro
resistance profile of bictegravir compared to currently available
INSTIs dolutegravir (DTG), elvitegravir (EVG) and raltegravir
(RAL). Bictegravir demonstrated an improved resistance profile
compared to DTG and a markedly improved profile compared to EVG and
RAL against a panel of HIV integrase mutant viruses. Results also
showed an improved resistance profile against all other INSTIs in
patient isolates, particularly those with high-level INSTI
resistance.
Poster 414: Discovery of GS-9883, an HIV-1 Integrase Strand
Transfer Inhibitor (INSTI) with Improved Pharmacokinetics and In
Vitro Resistance Profile
- Several INSTI candidates were tested
for a range of properties including HIV-1 potency, metabolic
stability, cytotoxicity and protein binding. Bictegravir was shown
to be a potent INSTI with improved preclinical pharmacokinetics and
an enhanced resistance profile compared to all currently available
INSTIs—RAL, EVG and DTG. Bictegravir also exhibited a low potential
for drug-to-drug interactions.
Poster 415: Novel Integrase Strand Transfer Inhibitor
Bictegravir 10 Day Monotherapy in HIV-1 Infected Patients
- Twenty adults (19 male) with chronic
HIV infection were treated with bictegravir (5, 25, 50 or 100 mg)
or placebo once daily for 10 days to determine changes in HIV-1 RNA
levels (viral load). Bictegravir was well tolerated at all dosing
levels and provided rapid dose-dependent decreases in viral load
that were sustained throughout the treatment period. There were no
reports of primary resistance mutations in integrase, no serious
adverse events (AEs) and no discontinuations due to AEs.
Poster 416: Antiviral Activity of GS-9883, a Potent
Next-Generation HIV-1 Integrase Strand Transfer Inhibitor
- The study analyzed in vitro antiviral
activity of bictegravir alone and in combination with TAF, FTC and
darunavir (DRV). Bictegravir alone was highly potent against HIV-1
infected target cells and demonstrated no antiviral effect against
non-HIV viruses. In combination with TAF, FTC and DRV, bictegravir
was highly synergistic against HIV-1. Bictegravir exhibited low
cytotoxicity in non-target human cell lines.
Further information about the clinical studies described above
can be found at www.clinicaltrials.gov.
Bictegravir, including in combination with TAF and FTC as a
single tablet regimen, is an investigational treatment for HIV that
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,
including the possibility of unfavorable results from other
clinical trials involving bictegravir. As a result, bictegravir 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 March
31, 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-5or 1-650-574-3000.
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