Faiez Zannad, MD, PhD, Nancy

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2 Biotargets, drug discovery and therapeutic innovation. How French clinical networks can accelerate the discovery of new treatments in the field of cardiovascular and metabolic diseases? Faiez Zannad, MD, PhD, Nancy

3 The network of Clinical Investigation Centers CARDIOVASCULAR Bichat Robert Debré Garches Saint-Louis Lille Necker Enfants Malades HEGP HEGP Cochin Pasteur Les Pitié- Salpêtrière Saint- Antoine Henri Mondor (94 Créteil) Brest Rennes Rouen Nancy Besançon Strasbourg IGR/Curie (Villejuif/Paris) Nantes Tours Dijon Poitiers Pointe-à-Pitre CIC-P (27) CIC-EC (9) Limoges Bordeaux Lyon Clermont- Ferrand Saint-Etienne Grenoble CIC-BT (10) Fort-de-France CIC-IT (8) Toulouse Montpellier Marseille Cayenne Ile de la Réunion

4 The network of Clinical Investigation Centers DIABETES and METABOLIC DISORDERS UMR6061 U620 U522 Rennes EMI9920 EMI9906 U921 Rouen Tours Ile de la Réunion Saint-Pierre Bordeaux Lille Bichat U545 U530 Robert Debré U690 U561 Saint- U383 Antoine U680 U695 Nancy Strasbourg U498 UR545 U499 U308 EMI586 UMR5232 U626 Toulouse Montpellier Marseille U476 U317 IRD U608 EA4188 ESPRI25

5 Academic resources within a basic research and sophisticated technological environment and with immediate access to patients in University Hospitals Databases COHORTS Clinical trials Biobanks Patient organisations Disease Management programs

6 International funding bodies and consortia, with specific schemes of partnering with Industry

7 One solution to coordinate multicenter (multiple countries) trials EDDH, an Academic Research Organisation Advisory Board Faiez Zannad Alain Leizorovicz Gilles Montalescot Gabriel Steg European Drug Development Hub Under the Aegis of a Foundation

8 Academic Research Organization Coordination of 16 cardiovascular CICs National network of technicians and Technical research nurses Experienced Working in hospitals, Physician s office, patient s home Network of private practice Physicians - research practicioners GPs Cardiologists Psychiatrists INSERM label standardized procedures professional clinical researchers EDDH

9 An Industry- Academic collaboration with the aim to Assist Investigators to enroll more patients in clinical trials

10 SUCCESS STORIES How French clinical networks can accelerate discovery in the field of cardiovascular and metabolic diseases? A new class of medication A new potential biomarker

11 Aldosterone blockade prevents myocardial fibrosis Fibrosis % Survival RALES: Trial based Evidence 30% reduction in risk P < Spironolactone Biomarker Substudy Confirms mechanism of action Placebo 0.40 No fibrosis Circulation.1991;83: N Engl J Med. 1999;341: Circulation 2000

12 New Trial in Post MI, New drug (Eplerenone) acquired by Pfizer EPHESUS Cumulative survival rate (%) ACS French Registry; Aldosterone levels at admission are associated with poor outcome. Log-rank p=0.005 Quartile 1 (lowest) Quartile 2 Quartile 3 Quartile 4 (highest) Days N Engl J Med. 2003

13 Twin trials ALBATROSS (academic) and REMINDER (Industry) STEMI, Anterior, LVEF > 40%, HF signs/symptoms, CK- MB>x or Troponin>y orbnp> z, Standard Therapy* Eplerenone 25 mg QD up to week 4 Randomize < 48 hours Placebo From onset of symptoms Primary end points: Death or (MRI) LVEF<30% within 30 days Secondary end points: All-cause mortality CV mortality Length of Stay

14 New drugs : Aldosterone inhibitors Genration Selectivity (sex side effects) potency Vasculra/renal effect Priamry Aldo Antiinflammatory First Spiro Second Eplerenone Third Non steroidal Fourth Non renal

15 Aldosterone inhibitors: Potential indications 1. Primary hyperaldosteronism 2. Glucocorticoid remediable aldosteronism (GRA) 3. Low renin/high aldosterone hypertension 4. Resistant hypertension 5. Congestive heart failure 6. Liver cirrhosis 7. Metabolic syndrome 8. High normal blood pressure

16 LCI699 (Aldo synthase inhibitor) in Patients With Primary aldosteronism : proof of concept study in the CIC CV network Design 4 week, Single-blind, Forced-titration Patients: Hypertensive patients with primary aldosteronism Objectives: to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability

17 Pharmacological postconditioning (Inhibition of mitochondrial permeability transition) INSERM Unité 886, Lyon Am J Physiol Heart Circ Physiol. 2007

18 From Bench to Bedside Pharmacological postconditioning Cyclosporine A Hôpital Arnaud de Villeneuve, Montpellier, Hospices Civils de Lyon, Service de Cardiologie, Mulhouse NEJM, 2008 PHRC CYCLADE, Post Surgical conditioning

19 Pro-M22: a new biomarker in acute heart failure Discovery: Validation Proteomics, human failing heart plasma of dyspneic patients BNP (ELISA) Pro-M22 (MS) S2 P2 S1 P1 Sensitivity Specificity AUC BNP: 0.86; AUC Pro-M22: 0.88 Pronota, Inserm, AP-HP, Paris 7 GREAT Network (15 countries) A Mebazaa, JL Samuel, A Cohen Solal et al U 942 Inserm

20

21 Derivation to Validation: CV CIC Network

22 The Stanislas Cohort 1006 families, 4295 subjects enrolled in the program 600 demographics and laboratory dataset values 117 original publications «Open access» to international scientific community Feasibility Visit 1 Visit 2 Visit 3 Visit Preventive Medicine Center and Clinical Investigation Center, Nancy

23 Genetic Epidemiology and Biobanks" Aortic stenosis genetics Probst et al, Circulation 2006 One common ancestor born in the XVIth century

24 SYNERGISM

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