OUR MISSION: DELIVERING THE PROOF OF THE

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1 OUR MISSION: DELIVERING THE PROOF OF THE HEALTH EFFECTS REVIEW OF THE LATEST RESEARCH INTO DIETARY RISKS TO CARDIO HEALTH AND THEIR IMPLICATIONS FOR FOOD DEVELOPMENT ERIC CHAPPUIS DIRECTOR, CONSULTING FOOD MATTERS LIVE LONDON / NOV 19TH, 2014

EURASANTÉ PARK, MEMBER OF THE NUTRITION- HEALTH- LONGEVITY CLUSTER A

dietitians, regulatory experts OUR SERVICES CONSULTING Scientific and regulatory

Design, set-up, monitoring and management of clinical trials MANAGEMENT TEAM

2 NATURALPHA WHO ARE WE? INDEPENDENT COMPANY FOUNDED IN 2001 LOCATED IN THE HEART OF LILLE, FRANCE - EURASANTÉ PARK, MEMBER OF THE NUTRITION- HEALTH- LONGEVITY CLUSTER A MULTIDISCIPLINARY TEAM OF 25 EXPERTS Physicians, engineers, PhDs, nutritionists, dietitians, regulatory experts OUR SERVICES CONSULTING Scientific and regulatory consulting LABS Preclinical validation, in vivo & in vitro CLINICAL TRIALS Design, set-up, monitoring and management of clinical trials MANAGEMENT TEAM Stéphane POSTIC / CEO Marie-Noëlle BOUVERNE / Clinical Project Coordinator Eric CHAPPUIS / Consulting Director Elodie HARMEL / Scientific Affairs Manager (PhD) 2

NATURALPHA 12 YEARS OF EXPERTISE WITH THE LEADING NUTRITION & HEALTH INDUSTRIES A

CLINICAL, REGULATORY AND BUDGETARY ASPECTS CONSULTING Regulatory and scientific

management TRUSTED PARTNER OF LEADING NUTRITION & HEALTH COMPANIES 50 MAJOR EUROPEAN

3 NATURALPHA 12 YEARS OF EXPERTISE WITH THE LEADING NUTRITION & HEALTH INDUSTRIES A TRANSVERSAL APPROACH FOR YOUR R&D PROJECTS TAKING INTO CONSIDERATION SCIENTIFIC, CLINICAL, REGULATORY AND BUDGETARY ASPECTS CONSULTING Regulatory and scientific consulting LABS in vitro & in vivo preclinical validation CLINICAL RESEARCH Design and management TRUSTED PARTNER OF LEADING NUTRITION & HEALTH COMPANIES 50 MAJOR EUROPEAN PARTNERS: DIETARY SUPPLEMENT LABORATORIES, INGREDIENTS SUPPLIERS, AGRI-FOOD AND BIOTECHNOLOGY INDUSTRIES 3

4 RISK FACTORS VS BIOMARKERS RISK FACTOR Measurable biological characteristics of an individual that precede a well-defined outcome of that disease, predict that outcome, and are directly in the biological causal path BIOMARKER Biological indicators for processes that are involved in developing a disease that may or may not be causal A biomarker can be a form of risk factor that is not causal A biomarker can qualify to be a risk factor when it is causal Being causal is not a necessary characteristic for a biomarker 4

5 SURROGATE MARKERS 5

6 RISK FACTORS & BIOMARKERS DISCOVERY MAKING THE LINK Meta-analyses Interventional Causality Observational cohort Observational Preclinical 6

7 TRADITIONAL RISK FACTORS Family history Ethnicity Blood lipids Gender High blood pressure Age CVD Smoking Diabetes / Hyperglyc Physical activity +/- OVweight / Obesity Diet 7

8 TRADITIONAL RISK FACTORS DEATH ATTRIBUTABLE TO RISK FACTORS WW 8

9 NUTRITION & RISK FACTORS & Modifiable risk factors Biomarkers Others LDLc BP etc Smoking? Physical activity? Diet (SFA repl.)? 9

10 EMERGING RISK FACTORS & BIOMARKERS ApoB Lp(a) Homocysteine Pro-thrombotic factors Pro-inflammatory factors Impaired fasting glucose 10

11 EMERGING RISK FACTORS & BIOMARKERS ApoB Major protein in pro-atherogenic lipoproteins Represent pro-atherogenic particles Not better than non-hdlc in predicting CVD events Weaker than total cholesterol/hdl Interesting in patients with hypertriglyceridemia 11

12 EMERGING RISK FACTORS & BIOMARKERS Lp(a) Well-established relationship with CVD But no data on the interest of lowering it 12

13 EMERGING RISK FACTORS & BIOMARKERS Homocysteine Associated with increased thrombosis & endothelial dysfunction Elevation (even moderate) correlates with increased CVD risk No beneficial effect of lowering it on CVD risk 13

14 EMERGING RISK FACTORS & BIOMARKERS Pro-thrombotic factors Unstable atherosclerotic plaque may lead to platelet aggregation and acute thrombosis Platelet aggregation // atherosclerosis progression (mediator of endothelial function and inflammatory response) Fibrinogen In field studies relationship with CVD risk is less clear T-PA, t-pai-1, D-dimer, von Willebrand factor Associated with increased CVD risk No therapeutic intervention proven successful 14

15 EMERGING RISK FACTORS & BIOMARKERS Pro-inflammatory factors hscrp associated with acute CVD events, risk of CVD events and mortality Evidence that lowering hscrp prevents CVD events is limited (despite PROVE IT study with statins) 15

16 EMERGING RISK FACTORS & BIOMARKERS Impaired glucose metabolism Hyperglycemia and DM are associated to increased CVD risk Mild hyperglycemia below diabetes cut-off is also associated with increased CVD risk Direct cause of CVD? // associated with other other cardiometabolic co-morbidities Can manifest through IFG, IGT or elevated HbA1c Impairments associated with insulin resistance Not known whether treating pre-diabetes prevents CVD 16

17 CARDIOVASCULAR RISK FACTORS & BIOMARKERS USE IN NUTRACEUTICALS DEVELOPMENT Healthy Diseased Diagrammatic pattern of change of physiological functions with increasing age, reaching a clinically or functionally important threshold in old age (Young A. Philos Trans R Soc Lond B Biol Sci Dec 29;352(1363): ) NUTRA CAN ADDRESS BOTH PREVENTIVE AND THERAPEUTIC FRAME 17

5 HC Maintains normal concentrations of LDL Risk reduction Substance / Diet Risk factor Article 14 HC Decreases

18 CARDIOVASCULAR RISK FACTORS & BIOMARKERS USE IN NUTRACEUTICALS DEVELOPMENT NEEDS TO BE CONSIDERED IN TERMS OF Physiological function Substance / Diet Marker of physiological function Article 13.5 HC Maintains normal concentrations of LDL Risk reduction Substance / Diet Risk factor Article 14 HC Decreases LDL which is a risk factor for CHD Add-on therapy (in combination with drugs) Substance / Diet Risk factor Drug treatment Disease outcome? 18

PREVENTIVE APPROACH PHYSIOLOGICAL FUNCTION CONTRIBUTION VS RESTORATION VS IMPROVEMENT CLAIMS Physiological function level Vs market trends Improved Improvement in physiological function

19 PREVENTIVE APPROACH PHYSIOLOGICAL FUNCTION CONTRIBUTION VS RESTORATION VS IMPROVEMENT CLAIMS Physiological function level Vs market trends Improved Improvement in physiological function Health claim Normal Deteriorated Contribution / maintenance in physiological function Health claim Restoration in physiological function Health claim Healthy ageing Comfort Performance 19

20 PREVENTIVE APPROACH PHYSIOLOGICAL FUNCTION WHAT S NEW ON THE NUTRA SPACE? Traditional claims = cholesterol, BP But not so used for «Maintenance of normal levels» Hard-to-use claims = «Normal homocysteine metabolism» New claims = Platelet aggregation, FMD, LDL oxidation 20

21 PREVENTIVE APPROACH DISEASE RISK REDUCTION WHAT S NEW ON THE NUTRA SPACE? Limited new surrogate markers in CVD health Most of the market on traditional ones (Cholesterol, BP) Traditional solutions well established 21

PLANT STEROLS & HYPERCHOLESTEROLEMIA Diagnosis of HCT 6 wks Evaluate LDLc response If LDLc goal not achieved, intensify LDLc lowering ttt 6 wks Evaluate LDLc response If LDLc goal not achieved,

consumption Consider referral to a dietitian Reinforce reduction in saturated fat and cholesterol Consider adding plant sterols/stanols Increase fiber intake Consider referral to a dietitian Initiate

22 PLANT STEROLS & HYPERCHOLESTEROLEMIA Diagnosis of HCT 6 wks Evaluate LDLc response If LDLc goal not achieved, intensify LDLc lowering ttt 6 wks Evaluate LDLc response If LDLc goal not achieved, consider adding drug ttt Every 4 to 6 months Monitor adherence to Therapeutic Lifestyle Changes and drug ttt Emphasize reduction in saturated fat and cholesterol Encourage moderate alcohol consumption Consider referral to a dietitian Reinforce reduction in saturated fat and cholesterol Consider adding plant sterols/stanols Increase fiber intake Consider referral to a dietitian Initiate treatment for metabolic syndrome Intensify weight management and physical activity Consider referral to a dietitian Therapeutic Lifestyle Changes (including diet) Drug Treatment Classic scheme to treat hypercholesterolemia (NCEP-ATP III) 22

23 PREVENTIVE APPROACH DISEASE RISK REDUCTION NEW SOLUTIONS TO ENVISAGE? 23

PREVENTIVE APPROACH DISEASE RISK REDUCTION USING NEW RISK FACTORS FOR

THE CASE OF WEIGHT REDUCTION Few claims on weight reduction at EU level

weight Regulatory Health claim dossier (EFSA / EC) on Solution & Weight

24 PREVENTIVE APPROACH DISEASE RISK REDUCTION USING NEW RISK FACTORS FOR TARGETING CVD RISK IN A HC CONTEXT? THE CASE OF WEIGHT REDUCTION Few claims on weight reduction at EU level Solution (substance / Diet ) R&D Weight reduction in subjects with excess weight Regulatory Health claim dossier (EFSA / EC) on Solution & Weight reduction Regulatory HC dossier on Solution & Weight, which is a risk factor for CVD 2 CLAIMS FOR (ALMOST) THE PRICE OF ONE? AND LIMITED R&D TIME? 24

25 THERAPEUTIC APPROACH ADD-ON THERAPIES PATIENTS WITH CVD HAVE TROUBLES MEETING THEIR GOALS HOWEVER NOT SO MUCH NUTRACEUTICALS SOLUTIONS Positioned on the add-on therapy market With clinical POC or POE! 25

26 TAKE HOME MESSAGES ALREADY MANY CARDIOVASCULAR TARGETS CAN BE ENVISAGED IN NUTRACEUTICAL DEVELOPMENT Benefits from Pharma work! But few new risk factors / lack of causality BUT NUTRACEUTICALS ADDRESS DISEASE RISK BUT ALSO NORMAL PHYSIOLOGICAL FUNCTION New targets for Nutraceutical solutions, beyond LDLc! Consumer & HCP education must follow EFSA OFFERS NEW OPPORTUNITIES OF STRATEGY Re-thinking ingredient portfolio through risk factors frame ADD-ON THERAPY AS ANOTHER ALTERNATIVE 26

27 CNCN Centre de Nutrition Clinique Naturalpha On Naturalpha SAS - Parc Eurasanté avenue Eugène Avinée Loos - France

Cardiovascular Complications of Diabetes

VBWG Cardiovascular Complications of Diabetes Nicola Abate, M.D., F.N.L.A. Professor and Chief Division of Endocrinology and Metabolism The University of Texas Medical Branch Galveston, Texas Coronary