GlaxoSmithKline PLC ViiV Healthcare announces positive results (3616E)
November 03 2015 - 6:56AM
UK Regulatory
TIDMGSK
RNS Number : 3616E
GlaxoSmithKline PLC
03 November 2015
PRESS RELEASE
ViiV Healthcare announces positive headline results from a study
of two drug injectable regimen for HIV maintenance therapy
London, UK, 3 November 2015 - ViiV Healthcare, a global
specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited
as shareholders, today announced that the Phase IIb study LATTE 2
(NCT02120352) met its primary endpoint at 32 weeks. These results
show that the investigational, long acting, injectable formulations
of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) were
comparable in maintaining viral suppression rates to a three drug
oral regimen of investigational cabotegravir and two nucleoside
reverse transcriptase inhibitors (NRTIs). The 32 week results of
LATTE 2 will be presented at a forthcoming scientific conference.
ViiV Healthcare and Janssen Sciences Ireland UC (Janssen) are
collaborating to conduct LATTE 2.
Viral suppression rates (plasma HIV-1 RNA <50 c/ml by FDA
snapshot analysis) for patients at 32 weeks receiving two drug
maintenance therapy with investigational long acting cabotegravir
(CAB LA) and long acting rilpivirine (RPV LA) dosed every 8 weeks
(Q8W, 95%) or every 4 weeks (Q4W, 94%) were comparable to the rate
observed in patients continuing with a three drug oral regimen of
investigational CAB + NRTIs (91%).
Patients switching to CAB LA and RPV LA administered Q4W
reported more adverse events (AEs) leading to withdrawal (5%; n=6)
compared with those receiving an injection Q8W (2%; n=2) or who
continued on oral CAB + NRTIs (2%, n=1). The most common adverse
event (AE) reported by patients was injection site pain (93% of
injection recipients). Two patients in the Q8W arm (none in the Q4W
arm) withdrew for injection intolerance. Two patients met protocol
defined virologic failure criteria, Q8W (n=1), oral (n=1); neither
patient had evidence of resistance at failure.
"ViiV Healthcare is committed to identifying new therapeutic
options for physicians and people living with HIV. These initial
phase IIb data investigating long-acting cabotegravir and
rilpivirine are promising and build on the results we have seen to
date. We look forward to seeing further results as we move into
phase III," said John C Pottage, Jr, MD, Chief Scientific and
Medical Officer, ViiV Healthcare.
Following the results of the proof of concept two-drug oral
dose-ranging study LATTE(1) , LATTE 2 was initiated as a phase IIb,
multicentre, open label 96 week study investigating CAB LA with RPV
LA as a two-drug antiretroviral (ART) regimen for suppressive
maintenance therapy in ART-naïve, HIV infected adults. LATTE 2
included adults (n=309) who, after reaching virologic suppression
on oral therapy with once-daily investigational oral cabotegravir
30mg + 2 NRTIs (n=286, 93%), were subsequently randomised to one of
three study arms to receive either CAB LA + RPV LA injections every
4 weeks (n=115, Q4W), 8 weeks (n=115 Q8W) or continued on oral CAB
+ NRTIs (n=56).
About cabotegravir
Cabotegravir is an investigational integrase strand transfer
inhibitor (INSTI) and analogue of dolutegravir (Tivicay(R)).
Cabotegravir is being developed by ViiV Healthcare for the
treatment and prevention of HIV and is currently being evaluated as
a once-daily oral tablet formulation and as a LA nanosuspension
formulation for intramuscular (IM) injection.
About Edurant(R) (rilpivirine)
Rilpivirine is a once daily non-nucleoside reverse transcriptase
inhibitor (NNRTI) used for the treatment of human immunodeficiency
virus (HIV--1) infection in combination with other antiretroviral
agents in antiretroviral treatment-naïve adult patients with a
viral load <= 100,000 HIV RNA copies/mL.
Rilpivirine was developed by Janssen. Rilpivirine is approved in
US and EU as EDURANT(R) as a single agent tablet dosed at 25mg
taken once a day. The overall safety profile of rilpivirine is
based on Phase III clinical studies. Rilpivirine is also available
in the United States (US) and the European Union as part of a once
daily fixed dose antiretroviral combination with Gilead Sciences
Inc's tenofovir and emtricitabine. This combination, known as
COMPLERA(R) (US) or EVIPLERA(R).
Rilpivirine is currently being developed as a long-acting
nanosuspension formulation for intramuscular (IM) injection.
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. 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 new HIV medicines, 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
ViiV Healthcare Contacts:
Sébastien Desprez (UK) +44 7920 567 707
Global Communications
ViiV Healthcare
Marc Meachem (US) +1 919 483 8756
US Communications
ViiV Healthcare
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Alspach +1 202 715 (Washington,
1048 DC)
Sarah Spencer +1 215 751 (Philadelphia)
3335
Analyst/Investor Ziba Shamsi +44 (0) 20 (London)
enquiries: 8047 5543
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
References:
1. Margolis DA et al., Cabotegravir plus rilpivirine, once a
day, after induction with cabotegravir plus nucleoside reverse
transcriptase inhibitors in antiretroviral-naive adults with HIV-1
infection (LATTE): a randomised phase 2b dose-ranging trial. Lancet
Inf Dis 2015:15(10):1145-55
This information is provided by RNS
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