TIDMGSK
RNS Number : 8495J
GlaxoSmithKline PLC
22 August 2019
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: 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] 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.
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END
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