UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER
THE
SECURITIES EXCHANGE ACT OF 1934
For the
month of July, 2019
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8
9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
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/µL], a mean increase of 66 cells/µL from Week
48). In the randomised cohort at Week 96, 67% of patients with
a baseline CD4 <200 cells/µL increased to a CD4 ≥200
cells/µL, and 56% of patients with a baseline CD4 <50
cells/µL increased to a CD4 ≥200
cells/µL.
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/lL compared to ≥200 cells/lL 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/lL in participants with baseline CD4 counts < 20
cells/lL.
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
|
|
Analyst/Investor
enquiries:
|
Kristen
Neese
Sarah
Elton-Farr
|
+1 804
217 8147
+44 (0)
20 8047 5194
|
|
|
Danielle
Smith
James
Dodwell
|
+44 (0)
20 8047 0932
+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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: July
22, 2019
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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