GSK announces positive Phase III efficacy and safety data for daprodustat in patients with anaemia due to chronic kidney disease

  • Late-breaking data from the daprodustat ASCEND-ND and ASCEND-D trials at the American Society of Nephrology’s Kidney Week 2021 confirms the potential for a new oral treatment for patients with anaemia due to chronic kidney disease in both non-dialysis and dialysis settings
  • Data from five Phase III studies demonstrated that daprodustat improved or maintained haemoglobin within target levels, without increased cardiovascular risk when compared to standard of care
  • Pivotal trials in non-dialysis and dialysis populations published simultaneously in the New England Journal of Medicine

GlaxoSmithKline plc (LSE/ NYSE GSK) moment blazoned positive results from the Phase III ASCEND (Anaemia Studies in Habitual Order Disease Erythropoiesis via a new prolyl hydroxylase asset Daprodustat) programme for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase asset (HIF-PHI), during a donation at the American Society of Nephrology’s Order Week 2021. The positive primary efficacity and safety results confirm the eventuality for daprodustat to be a new oral treatment for cases with anaemia due to habitual order complaint (CKD) in bothnon-dialysis and dialysis settings. Daprodustat was developed grounded upon the unique Nobel Prize- winning wisdom that demonstrated how cells smell and acclimatize to oxygen vacuity.

The ASCEND programme is comprised of five Phase III studies assessing the efficacity and safety of daprodustat for the treatment of anaemia due to CKD across the CKD complaint course. The programme enrolled over cases who were treated for over to4.26 times. Daprodustat was well permitted in bothnon-dialysis and dialysis populations as assessed in the primary analysis. Data on daprodustat, including results from the two vital Phase III studies concentrated onnon-dialysis (ASCEND-ND) and dialysis (ASCEND-D) cases, were participated at the American Society of Nephrology’s meeting in a combined late- breaking oral donation. Results for ASCEND-ND and ASCEND-D were also published contemporaneously in the New England Journal of Medicine.
The ASCEND-ND and ASCEND-D studies each singly met their primary efficacity and safety endpoints. Efficacity results from both Phase III studies demonstrated that daprodustat bettered or maintained cases within their target haemoglobin (Hb) range. In addition, results from the prespecified primary safety analysis of the intention-to- treat (ITT) population showed analogous rates of major adverse cardiovascular events (MACE), defined as all- cause mortality,non-fatal myocardial infarction ornon-fatal stroke singly within each trial. In the ASCEND-ND trial, results showed a hazard rate reflecting time to first circumstance of MACE of1.03; 95 CI, (0.89 to1.19), achievingnon-inferiority with thepre-defined periphery of1.25. In the ASCEND-D trial, results showed a hazard rate reflecting time to first circumstance of MACE of0.93; 95 CI, (0.81-1.07), achievingnon-inferiority with thepre-defined periphery of1.25. The issues in each study and across treatment arms verified no increased cardiovascular threat for daprodustat compared to an erythropoietin stimulating agent (ESA), the current standard of care.

Data from three fresh trials within the ASCEND programme handed farther support for the use of daprodustat. The ASCEND-TD trial showed positive efficacity results for three- times daily dosing, in addition to the formerly-diurnal dosing authority estimated in ASCEND-ND and ASCEND-D studies, furnishing data to support fresh dosing options for daprodustat. Fresh results demonstrated treatment with daprodustat led to significant enhancement compared to placebo innon-dialysis dependent cases’Hb situations and quality of life by measure of SF-36 vitality score (as determined by position of fatigue) in the ASCEND-NHQ trial, as well as the capability to maintain Hb situations in the high- threat incident dialysis population in the ASCEND-ID trial.
Results from the ASCEND-ND and ASCEND-D trials

ASCEND-ND (Anaemia Studies in CKD Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) enrollednon-dialysis dependent cases with anaemia associated with CKD who were either switched from standard of care (ESA) or not presently entering ESA remedy to admit daprodustat or ESA control (darbepoetin alfa). Forceful operation protocols were introduced across both arms in the study. The study met its primary safety and efficacity endpoints. Results showed daprodustat bettered and/ or maintained Hb within target position (10-11.5 g/ dL) for these cases, and the primary safety analysis of the ITT population showed that daprodustat achievednon-inferiority compared to ESA control.
ASCEND-D (Anaemia Studies in CKD Erythropoiesis via a Novel PHI Daprodustat-Dialysis) enrolled dialysis cases with anaemia associated with CKD who were switched to admit daprodustat or ESA control from a standard of care ESA remedy. A invariant iron operation protocol was introduced across both arms of the study. The study met its primary safety and efficacity endpoints. Results showed daprodustat bettered or maintained Hb within target situations (10-11.5 g/ dL) for these cases, and the primary safety analysis of the ITT population showed that daprodustat achievednon-inferiority compared to ESA control.
About anaemia due to CKD

About daprodustat

Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase asset (HIF-PHI), belongs to a new class of oral drugs indicated for the treatment of anaemia due to habitual order complaint (CKD) in adult cases not on dialysis and on dialysis. Inhibition of oxygen- seeing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to recap of erythropoietin and other genes involved in the correction of anaemia, analogous to the physiological goods that do in the body at high altitude. Daprodustat has been developed to give a accessible oral treatment option for cases with anaemia associated with CKD.

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