ENABLE (IMI) presentation of activities

Transcription

1 ENABLE (IMI) presentation of activities A European antibacterial drug discovery platform Anders Karlén Uppsala University (SE)

2 New Drugs for Bad Bugs (ND4BB) Structure ND4BB Co-ordination team (science and management leads for topics) Jan 2013 Jan 2013 Feb 2014 Q Q * 2015* Topic 1: COMBACTE a) Enabling Clinical Collaboration and refining clinical trial design b) Clinical Development of GSK c) Clinical Development of MEDI4893 Topic 2 : TRANSLOCATION Research penetration and efflux Gramnegatives Data Hub and Learning from R&D experience Topic 3 : ENABLE Discovery & development of new drugs combating Gram negative infections Topic 4: Driving reinvestment in R&D and Responsible use of Antibiotics Topic 5: Clinical development of antibacterial agents for Gram-negative antibiotic resistant pathogens Topic 6: Epidemiology Research & Systemic molecules against HAIs due to clinically challenging Gram-negative pathogens Topic 7: Inhaled Antibacterials in CF and non- CF BE ND4BB Information Centre All summary data generated is submitted and is accessible to all consortium partners *Topics 6 and 7 were Launched as part of the 11 th Call. EOIs are due April 8 th

3 ENABLE who we are European Gram Negative Antibacterial Engine (ENABLE) Public Consortium with 28 partners: 11 academic/institute/hospital organizations 5 non profit partners 12 SMEs EFPIA: GlaxoSmithKline (Coordinator) Sanofi (Co coordinator) AstraZeneca Basilea Red markers correspond to the geographic location of the public consortium 3

4 ENABLE Goals and Objectives ND4BB TOPIC 3: One of the major challenges in antibiotic discovery is turning Hits and Leads into development candidates ENABLE Objectives : Create a collaborative drug discovery platform Increase the overall pipeline in the antibacterial area ENABLE Goals: Target the systemic treatment of infections due to resistant Gramnegative bacterial pathogens E. coli, K. pneumoniae, P. aeruginosa and A. baumannii identifying three antibacterial Leads identifying two antibacterial development Candidates progressing at least one compound into Phase 1 clinical studies 4

5 Project Concept Subtopic 3A Drug Discovery Platform Medicinal chemistry, Microbiology, ADME etc. ENABLE EFPIA: expertise & advice Consortium Management Office Subtopic 3B Programmes with novel mechanisms Public partners Private partners (GSK/Sanofi L2CD) Additional public programmes from open calls Hit to Lead Portfolio Management Committee Lead to Candidate Candidate to Phase 1 Phase 1 clinical trial 5

6 Feeding the ENABLE antibacterial pipeline February 1 ENABLE Launches (seven potential programmes) 2014 February 24 1 st PMC Meeting March 19 1 st Open call Multiple expressions of interest submitted from open call May 27 2 nd PMC Meeting Open calls every 6 months ENABLE Drug Discovery Platform 4 H2L programmes in parallel 2 L2CD programmes in parallel Seven programmes evaluated Three enter ENABLE pipeline 2 H2L programmes 1 L2CD programme 6

7 Programmes: Open Call Process Search for additional programmes Open Call Same minimum criteria as originally defined in the IMI 8 th Call Evaluated by two external, independent experts Rolling Call with evaluation cycle every 6 months Potential programmes identified will be reviewed by the PMC 7

8 Hit to Lead Programmes: Minimum Criteria at Time of Submission Molecules or series with a novel mode of action targeting key Gram negative bacteria may enter the Hit to Lead phase of ENABLE. Minimum criteria; MIC 32 μg/ml vs. a key Gram negative pathogen (E. coli, K. pneumoniae, P. aeruginosa, A. baumannii) Activity not due to non specific activity Proven chemical structure, preliminary SAR Favourable chemical properties Reasonable route of synthesis (or availability of product if natural product derived) Promising physchem parameters Molecules or series with a novel mode of action may also enter the Lead to CD phase of ENABLE directly More information on the ENABLE website enable.eu/open calls 8

9 Summary The ENABLE consortium has brought together the skills and expertise from the public and private sectors to: Create an antibacterial drug discovery platform Recruit the best programmes from across Europe Educate the next generation of antibacterial drug discovery experts Identify two antibacterial development candidates Progress at least one compound into preclinical and Phase 1 clinical studies 9

10 ENABLE A fully integrated public private partnership in drug discovery in Europe A new model for collaborative drug discovery initiatives in other disease areas 10