TIDMGSK
RNS Number : 3307G
GlaxoSmithKline PLC
22 July 2019
Issued: 22 July 2019, London UK - LSE Announcement
PRESS RELEASE
ViiV Healthcare presents positive 96-week data from phase III
study of investigational fostemsavir in heavily
treatment-experienced patients with HIV at IAS 2019
Week 96 data from the BRIGHTE study of first-in-class
fostemsavir continue to show improvement in virologic suppression
and immunologic response
London, UK, 22 July 2019 - ViiV Healthcare, the global
specialist HIV company majority owned by GSK, with Pfizer Inc. and
Shionogi Limited as shareholders, today announced positive Week 96
results from the phase III BRIGHTE study of investigational
fostemsavir in heavily treatment-experienced adults with HIV-1
infection.
The BRIGHTE study is a two-cohort (randomised and
non-randomised), phase III clinical trial evaluating the safety and
efficacy of fostemsavir, a first-in-class attachment inhibitor,
used in combination with optimized background treatment (OBT) after
Day 8. In the randomised cohort, rates of virologic suppression and
immunologic response increased from Week 48 to Week 96 in this
difficult-to-treat population with multidrug resistant HIV-1.[1]
These findings were presented today at the 10(th) International
AIDS Society Conference of HIV Science (IAS 2019) in Mexico
City.
Kimberly Smith, M.D., Head of Global Research & Medical
Strategy at ViiV Healthcare, said: "People living with HIV who are
heavily treatment-experienced have few options available to them
due to the complexities of resistance, safety, tolerability,
contraindications and prior treatment failure. We believe searching
for new ways to prevent the virus from replicating is important,
especially for those who develop resistance to their treatment
regimens, and the findings from BRIGHTE reinforce fostemsavir as a
potential treatment option for these individuals. We look forward
to completing the necessary regulatory approval process to make
this promising therapy available to the people living with HIV who
need it."
At Week 96, 60% of patients receiving fostemsavir plus OBT in
the randomised cohort (n=163/272) achieved virologic suppression
(HIV-1 RNA <40 copies per millilitre [c/mL]), an increase of 6%
from Week 48 results. Patients in the randomised cohort showed
continued immunologic improvement through Week 96 as demonstrated
by an increase in CD4+ T-cell counts (mean change from baseline of
+205 cells per microliter [cells/uL], a mean increase of 66
cells/uL from Week 48). In the randomised cohort at Week 96, 67% of
patients with a baseline CD4 <200 cells/uL increased to a CD4
>=200 cells/uL, and 56% of patients with a baseline CD4 <50
cells/uL increased to a CD4 >=200 cells/uL.1
Through Week 96, almost all patients who received fostemsavir
experienced at least one adverse event (AE), the most common of
which were nausea, diarrhoea and headache, respectively. At least
one serious adverse event (SAE) was experienced by 38% of the total
treated patients, the most common of which were attributed to
infections or infestations. In total, 3% of SAEs were related to
the study medication with few SAEs (1%) leading to discontinuation
of study medication.
Of the 29 deaths reported by Week 96, seven were AIDS-related
and 11 were acute infections, six were non-AIDS-related
malignancies and the remaining five were due to other conditions.
Twenty-three (23) of the 29 deaths (79%) occurred in patients with
baseline CD4+ T-cell counts <50 cells/ mm3. The median baseline
CD4+ T-cell counts for all patients who died was 11 cells/mm3.1
In addition to the Week 96 analysis, a pre-specified subgroup
analysis across age, gender and race, among other factors, was also
conducted and presented at IAS 2019. The findings from this
analysis build upon those identified at Week 48 and showed
comparable rates of virologic response in patients aged >50
years, females, or in patients who self-reported their race as
"black" or "African American" compared to their respective
counterparts through Week 96.[2]
The virologic response at Week 96 for the randomised cohort
increased from Week 48 and was comparable across most subgroups,
except those with well-established predictors of reduced response
[high baseline viral loads (VL), low baseline CD4 count]. A higher
percentage of participants with baseline CD4 counts < 20
cells/<MU>L compared to >=200 cells/<MU>L had SAEs
(46% vs. 27%) and deaths (8% vs. 3%). Importantly, immunologic
improvements were comparable across all subgroups analysed,
including a mean increase of 240 cells/<MU>L in participants
with baseline CD4 counts < 20 cells/<MU>L.2
ViiV Healthcare plans to commence the submission of regulatory
applications for fostemsavir, with the US New Drug Application
(NDA), later this year.
About BRIGHTE
BRIGHTE (NCT02362503) is a two-cohort (randomised and
non-randomised), phase III clinical trial evaluating the safety and
efficacy of the HIV-1 attachment inhibitor fostemsavir in heavily
treatment-experienced adults with HIV-1 infection. Three hundred
seventy-one patients enrolled. All had documented resistance,
intolerability, and/or contraindication to all antiretroviral (ARV)
agents in at least four of the six available ARV classes.[3]
Patients in the randomised cohort had to have one but no more
than two fully active ARV classes remaining at baseline and were
unable to form a viable antiretroviral regimen out of their
remaining agents. These patients were randomised 3:1 to add blinded
fostemsavir or blinded placebo (n=272) to their current failing
regimen for eight days of functional monotherapy. Patients without
any remaining fully active approved ARVs (n=99) were assigned to
the Non-Randomised Cohort and received open-label fostemsavir plus
optimised background therapy on Day 1.3
The primary endpoint of the study was mean change in log10 HIV-1
RNA between Day 1 and Day 8 for the Randomised Cohort. Beyond the
eight-day blinded period, all patients in the Randomised Cohort
received open-label fostemsavir plus optimised background therapy
(OBT). Key secondary endpoints include durability of response at
Weeks 24, 48 and 96, as well as safety changes from baseline CD4+
cell counts, and emergence of viral resistance.3
About the patient population
Antiretroviral (ARV) medicines have significantly decreased
mortality over the past 30 years; however, treatment failure and
antiviral resistance remain a concern for heavily
treatment-experienced patients and their providers. Failure of HIV
medicines to control the virus can result in selected mutations
resistant to one or more ARV medicines. Patient co-morbidities,
tolerability and safety issues may further decrease the number of
ARV therapies available to design effective treatment regimens for
these heavily treatment-experienced patients. As a result,
treatment options that address the complex needs of heavily
treatment-experienced people living with HIV remain a significant
unmet need.
About fostemsavir
Fostemsavir is an investigational prodrug of temsavir. Temsavir
binds directly to the gp120 subunit within the HIV-1 envelope
glycoprotein gp160 complex and prevents the initial interaction
between the virus and cellular CD4 receptors, thereby preventing
viral attachment to cellular CD4 receptors and entry into host
cells. Temsavir is not approved by regulatory authorities anywhere
in the world. Fostemsavir is being developed by ViiV Healthcare for
the treatment of HIV-1-infected heavily treatment-experienced
patients in combination with other antiretroviral (ARV) agents.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established
in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:
PFE) dedicated to delivering advances in treatment and care for
people living with HIV and for people who are at risk of becoming
infected with HIV. Shionogi joined in October 2012. The company
aims to take a deeper and broader interest in HIV/AIDS than any
company has done before and take a new approach to deliver
effective and innovative medicines for HIV treatment and
prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio,
pipeline and commitment, please visit www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2018.
ViiV Healthcare Media
enquiries: Melinda Stubbee +1 919 491 0831
Patricia O'Connor +44 (0) 20 8047 5982
Audrey Abernathy +1 919 605 4521
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502
Kristen Neese
+1 804 217 8147
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
Danielle Smith +44 (0) 20 8047 0932
James Dodwell +44 (0) 20 8047 2406
Jeff McLaughlin +1 215 751 7002
References
[1] Lataillade M, Lalezari J, Aberg J, et al. Week 96 safety and
efficacy of the novel HIV-1 attachment inhibitor prodrug
fostemsavir in heavily treatment-experienced participants infected
with multi-drug resistant HIV-1 (BRIGHTE Study). Presented at the
10th International AIDS Conference on HIV Science (IAS 2019), 21-24
July 2019, Mexico City, Mexico.
[2] Ackerman P, Aberg J, Molina JM, et al. A subgroup analysis
of the Week 96 efficacy and safety results evaluating fostemsavir
in heavily treatment experienced HIV-1 infected participants in the
Phase 3 BRIGHTE study: results from the Randomized Cohort.
Presented at the 10th International AIDS Conference on HIV Science
(IAS 2019), 21-24 July 2019, Mexico City,
[3] Clinicaltrials.gov. Attachment Inhibitor Comparison in
Heavily Treatment Experienced Patients. Available at:
https://clinicaltrials.gov/ct2/show/NCT02362503. Accessed July
2019.
NOTE TO EDITORS: ViiV Healthcare will hold a press conference at
IAS 2019 on Tuesday 23 July, 9:00 - 9:45 am CDT to preview
abstracts to be presented during the conference. To register,
please visit: http://bit.ly/IAS-ViiV
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END
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