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 August, 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 . . . . . . . .
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by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
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Issued by GlaxoSmithKline plc (LSE/NYSE: GSK): Thursday
22 August 2019, London UK
ViiV Healthcare reports positive phase III study results of
investigational, long-acting, injectable HIV-treatment regimen
administered every two months
ATLAS-2M study met its primary endpoint, showing similar efficacy
of cabotegravir and rilpivirine administered every eight weeks
compared to four-week administration
London, 22 August 2019 -
ViiV Healthcare, the global specialist HIV company majority owned
by GSK, with Pfizer Inc. and Shionogi Limited as shareholders,
today announced positive headline results from its global phase III
ATLAS-2M study of the investigational, long-acting, injectable,
2-drug regimen (2DR) of ViiV Healthcare's cabotegravir and
Janssen's rilpivirine for the treatment of HIV. The study was
designed to demonstrate the non-inferior antiviral activity and
safety of long-acting cabotegravir and rilpivirine administered
every eight weeks (two months) compared to every four weeks
(monthly) over a 48-week treatment period in adults living with
HIV-1 infection whose viral load is suppressed and who are not
resistant to cabotegravir or rilpivirine.
The study met its primary endpoint, showing that the long-acting
regimen of cabotegravir and rilpivirine, injected every two months,
was non-inferior to cabotegravir and rilpivirine administered every
month at Week 48. Non-inferiority was assessed by comparison of the
proportions of participants with plasma HIV-RNA ≥ 50 copies
per milliliter (c/mL) using the FDA Snapshot algorithm at Week 48
(Intent-to-Treat Exposed [ITTE] population). Overall safety,
virologic response and drug resistance results for the
every-two-months injectable regimen were consistent with results
from the phase III ATLAS study.
Kimberly Smith, M.D., Head of Research & Development at ViiV
Healthcare, said: "We are
excited to report that for the first time since the AIDS epidemic
started more than 30 years ago, our ATLAS-2M study has demonstrated
that it is possible to maintain suppression of the HIV virus with
an injectable regimen containing two drugs administered every two
months. This is further progress in our efforts to reduce the
number of medicines a person living with HIV must take while also
reducing the frequency of treatments. The ATLAS-2M study results
mean that people living with HIV could maintain viral suppression
with six total treatments per year, instead of a daily oral
treatment 365 times per year. Approval of this regimen would mark a
significant change in the HIV treatment
paradigm."
Detailed results from the ATLAS-2M study will be presented at an
upcoming scientific meeting.
This investigational, long-acting, injectable regimen is being
co-developed as a collaboration with Janssen Sciences Ireland UC
and has been submitted to regulatory authorities in the United
States, Canada and Europe. A Priority Review Designation for the
once-monthly injectable regimen was granted by the FDA with an
expected action date of December 29, 2019.
About ATLAS-2M (NCT03299049)
The ATLAS-2M study is a phase III, randomised, open-label,
active-controlled, multicentre, parallel-group, non-inferiority
study designed to assess the non-inferior antiviral activity and
safety of long-acting cabotegravir and rilpivirine administered
every eight weeks compared to long-acting cabotegravir and
rilpivirine administered every four weeks over a 48-week treatment
period in 1,045 adults living with HIV-1.P0F[1]P Subjects
were required to be virally suppressed for six months or greater,
on first or second regimen, with no prior failure. The primary
outcome measure for the study is the proportion of participants
with HIV-RNA ≥ 50 c/mL at Week 48 using the FDA Snapshot
algorithm (Intent-to-Treat Exposed [ITT-E]
population).
ATLAS-2M is part of ViiV Healthcare's extensive and innovative
clinical trial programme for 2-drug regimens. The study is being
conducted at research centres in Australia, Argentina, Canada,
France, Germany, Italy, Mexico, Russia, South Africa, South Korea,
Spain, Sweden and the United States.
For further information please see 34TUhttps://clinicaltrials.gov/ct2/show/NCT03299049U34T.
About cabotegravir
Cabotegravir is an investigational integrase inhibitor (INI) and is
not approved by regulatory authorities anywhere in the world.
Cabotegravir is being developed by ViiV Healthcare for the
treatment and prevention of HIV. It is being evaluated as a
long-acting formulation for intramuscular injection and also as a
once-daily oral tablet for use as a lead-in, to establish the
tolerability of cabotegravir prior to long-acting
injection.
About rilpivirine long-acting
Rilpivirine long-acting is an investigational, prolonged-release
suspension for intramuscular injection being developed by Janssen
Sciences Ireland UC and is not approved by regulatory authorities
anywhere in the world.
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's aim is 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 34Twww.viivhealthcare.com34T.
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 34Twww.gsk.com34T.
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:
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Melinda
Stubbee
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+1 919
491 0831
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Patricia
O'Connor
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+44 (0)
20 8047 5982
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Audrey
Abernathy
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+1 919
605 4521
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GSK
Global Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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Analyst/Investor
enquiries:
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Kristen
Neese
Sarah
Elton-Farr
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+1 804
217 8147
+44 (0)
20 8047 5194
|
|
Danielle
Smith
James
Dodwell
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+44 (0)
20 8047 0932
+44 (0)
20 8047 2406
|
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Jeff
McLaughlin
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+1 215
751 7002
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References
[1] Study evaluating the
efficacy, safety, and tolerability of long-acting cabotegravir plus
long-acting rilpivirine administered every 8 weeks in virologically
suppressed HIV-1-infected adults. Available
at: https://clinicaltrials.gov/ct2/show/NCT03299049.
Last accessed 22 August 2019.
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: August
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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