TIDMGSK
RNS Number : 5043F
GlaxoSmithKline PLC
16 July 2021
Issued: 16 July 2021, London UK - LSE announcement
GSK announces positive headline results from five Phase 3
studies of daprodustat for patients with anaemia due to chronic
kidney disease
Full results to be presented at a medical meeting later this
year
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive
headline results from five studies of the Phase 3 ASCEND programme,
evaluating the efficacy and safety profile of daprodustat, an
investigational oral hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI), for patients with anaemia due to chronic
kidney disease (CKD).
The ASCEND programme showed that daprodustat met its primary
efficacy endpoint in each study, demonstrating an improvement in
haemoglobin (Hgb) levels in untreated patients and maintaining Hgb
levels in patients treated with an erythropoietin stimulating agent
(ESA), a standard treatment option, in patients with anaemia of
CKD. In addition, the key cardiovascular outcomes studies for
non-dialysis (ASCEND-ND) and dialysis patients (ASCEND-D)
demonstrated that daprodustat was non-inferior when compared to an
ESA in the risk of Major Adverse Cardiovascular Events (MACE), the
co-primary endpoint of both studies.
Dr. Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: "I am particularly pleased with the results from the
ASCEND-ND and ASCEND-D studies given the importance of managing
cardiovascular outcomes for patients who are currently suffering
from anaemia due to chronic kidney disease, as well as the need to
provide a convenient, oral treatment option. We will continue to
analyse the data from the robust phase 3 ASCEND programme and look
forward to working closely with regulators as we plan for our
submissions."
In addition to the ASCEND-D and ASCEND-ND studies, the programme
also included studies focused on incident dialysis, for patients
just starting dialysis (ASCEND-ID); quality of life measures
(ASCEND-NHQ); as well as three-times weekly dosing regimens
(ASCEND-TD). Each of the studies from the programme met its
respective primary or co-primary endpoint(s). The programme
enrolled over 8,000 patients who were treated for up to 3.75 years.
The full results of the studies will be presented at a forthcoming
medical meeting later this year and will be used to inform
regulatory pathways with health authorities worldwide.
Across the ASCEND programme, daprodustat was generally well
tolerated in both non-dialysis and dialysis patients. The incidence
of treatment-emergent adverse events was similar between treatment
groups and the nature of reported events was consistent with the
underlying patient population. The most commonly reported adverse
events in patients receiving daprodustat across the ASCEND
programme included hypertension, diarrhoea, dialysis hypotension,
peripheral edema, and urinary tract infection.
Daprodustat is currently approved in Japan as Duvroq for
patients with renal anaemia. It is not approved anywhere else in
the world.
About Anaemia of CKD
Chronic kidney disease, characterised by progressive loss of
kidney function, is an increasing global public health burden.(1)
Risk factors for CKD include hypertension, diabetes, obesity and
primary renal disorders.(1) Furthermore, CKD is an independent risk
factor for cardiovascular disease.(1) Anaemia is an important and
frequent complication of CKD.(2) However, it is often poorly
diagnosed and undertreated in patients with early stage CKD, such
as those not on dialysis.(2) When left untreated or undertreated,
anaemia of CKD is associated with poor clinical outcomes and leads
to a substantial burden on patients and healthcare systems.(2)
About daprodustat
Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI), belongs to a novel class of oral medicines
indicated for the treatment of anaemia due to chronic kidney
disease in adult patients not on dialysis and on dialysis.
Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises
hypoxia-inducible factors, which can lead to transcription of
erythropoietin and other genes involved in the correction of
anaemia, similar to the physiological effects that occur in the
body at high altitude. Daprodustat has been developed to provide a
convenient oral treatment option for patients with anaemia
associated with CKD.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us .
GSK enquiries:
Media enquiries: Tim Foley +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor James Dodwell +44 (0) 20 8047 (London)
enquiries: 2406
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
Mick Readey +44 (0) 7990 (London)
339653
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
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 in the Company's
Annual Report on Form 20-F for 2020 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References
[1] Hill NR, Fatoba ST, Oke JL, et al. Global prevalence of
chronic kidney disease - A systematic review and meta-analysis.
PLoS One. 2016;11(7):e0158765.
[2] St Peter WL, Guo H, Kabadi S, et al. Prevalence, treatment
patterns, and healthcare resource utilization in Medicare and
commercially insured non-dialysis-dependent chronic kidney disease
patients with and without anemia in the United States. BMC Nephrol.
2018;19(1):67.
Wong MMY, Tu C, Li Y, et al. Anemia and iron deficiency among
chronic kidney disease stages 3-5 ND patients in the Chronic Kidney
Disease Outcomes and Practice Patterns Study: often unmeasured,
variably treated. Clin Kidney J. 2019. doi: 10.1093/ckj/sfz091
Hoshino J, Muenz D, Zee J, et al. Associations of hemoglobin
levels with health-related quality of life, physical activity, and
clinical outcomes in persons with stage 3-5 nondialysis CKD. J Ren
Nutr. 2020.
Toft G, Heide-Jorgensen U, van Haalen H, et al. Anemia and
clinical outcomes in patients with non-dialysis dependent or
dialysis dependent severe chronic kidney disease: a Danish
population-based study. J Nephrol. 2020;33(1):147-156.
Locatelli F, Pisoni RL, Combe C, et al. Anaemia in haemodialysis
patients of five European countries: association with morbidity and
mortality in the Dialysis Outcomes and Practice Patterns Study
(DOPPS). Nephrol Dial Transplant. 2004;19(1):121-132.
Hayashi T, Uemura Y, Kumagai M, et al. Effect of achieved
hemoglobin level on renal outcome in non-dialysis chronic kidney
disease (CKD) patients receiving epoetin beta pegol: MIRcerA
CLinical Evidence on Renal Survival in CKD patients with renal
anemia (MIRACLE-CKD Study). Clin Exp Nephrol.
2019;23(3):349-361.
Walker AM, Schneider G, Yeaw J, et al. Anemia as a predictor of
cardiovascular events in patients with elevated serum creatinine. J
Am Soc Nephrol. 2006;17(8):2293-2298.
Eriksson D, Goldsmith D, Teitsson S, et al. Cross-sectional
survey in CKD patients across Europe describing the association
between quality of life and anaemia. BMC Nephrol.
2016;17(1):97.
van Haalen H, Jackson J, Spinowitz B, et al. Impact of chronic
kidney disease and anemia on health-related quality of life and
work productivity: analysis of multinational real-world data. BMC
Nephrol. 2020;21(1):88.
Eriksson D, Teitsson S, Goldsmith D, et al. Cross-sectional
descriptive study of the impact of anaemia in patients with chronic
kidney disease on healthcare resource utilisation and work
productivity across Europe. Value Health. 2015;18(A514).
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
RESEAEXKFLNFEFA
(END) Dow Jones Newswires
July 16, 2021 07:00 ET (11:00 GMT)
Gsk (LSE:GSK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gsk (LSE:GSK)
Historical Stock Chart
From Apr 2023 to Apr 2024