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
NCT03060577 ORION-3 (CKJX839A12201E1)
Hypercholesterolemia inc. Atherosclerotic Cardiovascular Disease (ASCVD)
and ASCVD risk equivalents Heterozygous Familial Hypercholesterolaemia (HeFH)
Phase 2
490
LDL-C reduction at Day 210 for Group 1 subjects
Changes in other lipids and lipoproteins and reduction of LDL-C of more than 50%
for patients that are above LDL-C goal; longer term exposure and safety.
Group 1 - inclisiran sodium 300mg sc on Day 1 and every 180 days thereafter for
up to 4 years.
Group 2- Evolocumab 140mg s.c. injection on Day 1 and every 2 weeks until Day
336, followed by inclisiran 300mg on Day 360, Day 450 and then every 6 months for
a planned duration of 4 years.
Patients with HeFH or pre-existing atherosclerotic cardiovascular disease
(ASCVD) on background statin +/- ezetimibe therapy
Target Patients
Read-out Milesstone(s)
Publication
2022
TBD
NCT03705234 ORION-4 (CKJX839B12301)
Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH)
Phase 3
15000
A composite of major adverse cardiovascular events, defined as:
Coronary heart disease (CHD) death;
Myocardial infarction;
Fatal or non-fatal ischaemic stroke; or
Urgent coronary revascularization procedure
Arm 1: every 6 month treatment KJX839 300mg (given by
subcutaneous injection on the day of randomization, at 3 months and then every 6-
months) for a planned median duration of about 5 years
Arm 2: matching placebo (given bysubcutaneous injection on the day of
randomization, at 3 months and then every 6-
months) for a planned median duration of about 5 years.
Patient population with mean baseline LDL-C ≥ 100mg/dL
2026
TBD
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