Blueprint
FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 24 November 2016
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
Thursday, 24 November 2016, London UK
GSK starts phase III programme with daprodustat for anaemia
associated with chronic kidney disease
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced the start of a phase III
development programme investigating daprodustat, an oral
hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as
a treatment for anaemia associated with chronic kidney disease
(CKD).
The
phase III programme includes two studies evaluating the safety and
efficacy of daprodustat compared to recombinant human
erythropoietin:
●
ASCEND-D (Anaemia Studies
in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) will
enrol approximately 3,000 dialysis dependent subjects with anaemia
associated with CKD switching
from an erythropoietin-
stimulating agent (ESA).
●
ASCEND-ND (Anaemia Studies
in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis)
will enrol approximately 4,500 non-dialysis dependent subjects with
anaemia associated with CKD, and will include
patients
either switching from or naive to an ESA.
For
both studies, the co-primary endpoints are time to first occurrence
of major adverse cardiovascular events (MACE) and mean change in
haemoglobin between the baseline and efficacy period (mean over
Weeks 28-52). The studies will assess whether daprodustat is
non-inferior to recombinant human erythropoietin on these endpoints
as the primary analysis. If non-inferiority of the primary analysis
is met, superiority will be assessed for the safety
endpoint.
Julian
Jenkins, Vice President and Medicine Development Leader responsible
for the daprodustat programme, said: "For many patients with
chronic kidney disease, treating their anaemia comes with risks
associated with cardiovascular safety and injectable
administration. The start of phase III studies of daprodustat is an
important step in our work to explore whether daprodustat could
address those risks and provide a potential alternative, oral
treatment option."
The
design of the phase III programme is based upon data from phase II
clinical trials that were designed to characterise the
dose-response relationship between daprodustat and haemoglobin at 4
weeks and assess the safety and tolerability of daprodustat
following once-daily administration up to 24 weeks. Data from the
24-week phase II studies were presented at the American Society of
Nephrology Kidney Week congress in Chicago, Illinois, earlier in
November.
About anaemia
Anaemia
is the term used to describe a decrease in normal levels of red
blood cells. It is assessed by a patient's level of haemoglobin,
the component of red blood cells that transports oxygen throughout
the body. Anaemia commonly arises in patients with kidney
dysfunction because the kidneys no longer produce sufficient
amounts of erythropoietin, a hormone which stimulates red blood
cell production. Patients with chronic kidney disease or
kidney failure often experience varying degrees of anaemia as their
disease progresses. This limits oxygen delivery to tissues,
contributing to symptoms such as weakness and fatigue.
About daprodustat
Daprodustat
is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
Prolyl hydroxylase inhibition promotes the production of red
blood cells that carry oxygen to where it is needed, similar to the
effects that occur in the body at high altitude. Daprodustat is not
approved as a treatment for anaemia or any other indication
anywhere in the world.
About the phase III studies
The
ASCEND-D study (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) is a randomised, open-label
(sponsor blind), active-controlled, parallel-group, multi-centre,
event-driven study in dialysis subjects with anaemia associated
with chronic kidney disease to evaluate the safety and efficacy of
daprodustat compared to recombinant human erythropoietin, following
a switch from an erythropoietin-stimulating agent. The study aims
to randomise approximately 3,000 subjects (1,500 per treatment
arm). NCT02879305.
The
ASCEND-ND study
(Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) is a randomised, open-label
(sponsor blind) active-controlled, parallel-group, multi-centre,
event-driven study in non-dialysis subjects with anaemia associated
with chronic kidney disease to evaluate the safety and efficacy of
daprodustat compared to recombinant human erythropoietin. The study
aims to randomise approximately 4,500 subjects (2,250 subjects per
treatment arm). NCT02876835.
GSK - one of the world's
leading research-based pharmaceutical and healthcare companies - is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further
information please visit www.gsk.com.
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GSK enquiries:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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Sarah
Macleod
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+44 (0)
20 8047 5502
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(London)
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US Media enquiries:
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Sarah Alspach
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+1 202 715 1048
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(Washington, DC)
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Sarah Spencer
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+1 215 751 3335
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(Philadelphia)
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Karen Hagens
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+1 919 483 2863
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(North Carolina)
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Analyst/Investor
enquiries:
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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GSK cautionary statement regarding forward-looking
statementsGSK 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 'Risk factors' in the company's Annual Report on Form 20-F for
2015.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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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.
GlaxoSmithKline plc
(Registrant)
Date: November
24, 2016
By: VICTORIA
WHYTE
----------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GlaxoSmithKline plc