Q2 2021 Results - Reimagining Medicine
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
Financial performance
Innovation: Pipeline overview
Innovation: Clinical trials
Neuroscience
Oncology
Ophthalmology
Respiratory
Sandoz Biopharmaceuticals
Global Health
Abbreviations
CRM
IHD
KJX839 - siRNA (regulation of LDL-C)
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
NCT03814187 ORION-8 (CKJX839A12305B)
Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH)
and Homozygous Familial Hypercholesterolemia (HoFH)
Phase 3
2'991
Proportion of subjects achieving prespecified low density lipoprotein cholesterol
(LDL-C) targets at end of study
Safety and tolerability profile of long term use of inclisiran
Inclisiran sodium 300mg on day 1 (placebo patients entered into study from ORION
9, 10 & 11) or placebo on Day 1 (inclisiran patients entered into study from ORION
9, 10 & 11) then inclisiran 300mg on Day 90 and every 6 months for a planned
duation of 3 years
Patients with HeFH or pre-existing atherosclerotic cardiovascular disease
(ASCVD) on background statin +/- ezetimibe therapy and risk equivalents (patients
from ORION 9, 10 & 11 studies)
Read-out Milesstone(s)
2023
Publication
TBD
NCT03851705 ORION-5 (CKJX839A12302)
Hypercholesterolemia inc. Homozygous Familial Hypercholesterolemia (HoFH)
Phase 3
56
LDL-C reduction at Day 150
Changes in PCSK9, other lipids and lipoproteins
Part 1: inclisiran sodium 300mg on Day 1 and Day 90 or placebo on Day 1 and Day
90
Part 2: inclisiran on Day 180 for patients who were randomized to the placebo group
only, inclisiran on Day 270 and then every 6 months for a planned duration of 2
years for all patients
Patients with HoFH with background statin +/- ezetimibe therapy
Primary: Q3-2020 (actual); Final: H2-2021
TBD
62 Investor Relations | Q2 2021 Results
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