SomaLogic CVD 2º Risk Panel Flyer for Drug Developers

Clinical Trial Acceleration through
Risk Stratification
SomaLogic® CVD 2o Risk Panel
Predict Cardiovascular Events
If you could accurately predict the risk of a cardiovascular event at baseline,
how would that information impact how you design and conduct your trial?
■■ Validated for patients with stable coronary heart disease.
■■ Enroll patients with high risk into efficacy trials.
■■ Disqualify patients who are not likely to have an event.
■■ Reduce the number of patients enrolled.
■■ Accelerate time to endpoint.
Biomarker Discovery to Clinical Diagnostic Panel
An Exemplar in Cardiovascular Disease
■■ The SOMAscan® 1.1k Assay was used for hypothesis-free biomarker discovery
- 1,129 proteins measured simultaneously in 150 microliters of EDTA plasma
■■ 1,909 samples with outcomes and clinical metadata were analyzed to build and validate the algorithm1
■■ Machine learning was used to select biomarkers to predict myocardial infarction, congestive heart
failure, stroke/transient ischemic attack or death.
■■ A multi-protein panel assay was developed.
Risk Stratification Beyond Traditional Biomarkers
These 69 year-old men* are similar by traditional measures. They both have stable CHD and, by
definition, are classified as high risk for another event. Could an accurate prediction of cardiovascular
outcome impact trial design and accelerate time to endpoints?
BP
80/120 mm Hg
60/130 mm Hg
26.2
25.5
BMI
Total Cholesterol
173 mg/dL
142 mg/dL
HDL
41 mg/dL
38 mg/dL
LDL
110 mg/dL
79 mg/dL
17.6%
16.8%
6%
62%
no event
death
Framingham Risk Score
CVD Risk Score
Outcome
* Actual results from Heart & Soul and HUNT3 clinical trial participants
Accelerate Time to Endpoint
Assumptions in the financial model2
■■ Enrichment with 5-year CVD Risk Score >40%
■■ Includes increased cost for risk screening
■■ 20% of potential subjects are enrolled
■■ Endpoint for the enriched trial is defined by the # Events in the All Comers design
Phase 2 Phase 3
All Comers $45.5 M
$213.4 M
Total Cost
$258.9 M
Savings
Enriched
Phase 2
$35.8 M
$213.4 M
$249.2 M
$9.7 M
Enriched
Phase 2 & 3
$35.8 M
$176.5 M
$212.3 M
$46.6 M
0 12 2436 48 60
Time (months)
1- Ganz P et al. (2016). Development and Validation of a Protein-Based Risk Score for Cardiovascular
Outcomes Among Patients with Stable Coronary Disease. Journal of the American Medical
Association. Doi:10.1001/jama.2016.5951
2- Examination of Clinical Trial Costs and Barriers for Drug Development, HHS, July 2014
SomaLogic, SOMAscan and SOMAmer are registered trademarks of SomaLogic, Inc.
Copyright © 2016 SomaLogic, Inc. • DX-16-001 (rev 0 06/08/2016)
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