FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 11
Grant agreement number
115721

Contributions
IMI Funding
24 331 609
EFPIA in kind
30 213 513
Other
4 117 897
Total Cost58 663 019

Summary

Respiratory infections, frequently caused by drug-resistant bacteria, are the main cause of disease and death in people with cystic fibrosis (CF) and bronchiectasis (BE). Thanks to inhaled antibiotics, patients now live longer than ever before and enjoy a better quality of life. However, infections are increasingly becoming resistant to the few drugs available, putting patients’ lives at risk. The iABC project is advancing the development of two inhaled antibiotics for patients with CF and BE. It is also working to identify ways of improving clinical trials of treatments for these serious diseases.

Antimicrobial resistance (AMR) represents a serious and growing threat to human and animal health worldwide. In the EU alone, AMR is responsible for some 25 000 deaths every year, and the annual treatment and social costs have been estimated at €1.5 billion. Meanwhile, new forms of resistance continue to develop and spread, leaving clinicians with few weapons to bring infections under control. Yet despite the recognised need for new antibiotics, the reality is that only two new classes of antibiotics have been brought to the market in the last three decades.

A vulnerable group

Patients with cystic fibrosis (CF) and bronchiectasis (BE) are at particular risk of infection. CF is a common inherited disease that affects around 36 000 people in the EU. CF patients face regular respiratory infections; 60% of adult patients have lung infections caused by difficult to treat bacteria such as Pseudomonas aeruginosa, and respiratory failure is the cause of death for 95% of CF patients. Inhaled antibiotics have helped to both improve CF patients’ quality of life and extend their life expectancy.

BE refers to a group of diseases in which the airways become damaged and scarred. It is more common among the elderly, affecting 3 in 1 000 among the over 75s. BE patients experience similar symptoms to CF, including regular respiratory infections, often with Pseudomonas aeruginosa. So far, no inhaled antibiotics have been approved for use in BE patients, although in practice doctors often treat BE patients with antibiotics licensed for use in CF.

Today, the number of inhaled antibiotics available for these vulnerable patients remain limited and infections in both CF and BE patients are increasingly resistant to these life-saving medicines. The costs of carrying out clinical trials for new antibiotics for CF and BE patients are particularly high due to the relatively small number of patients affected.

Towards new treatments for cystic fibrosis and bronchiectasis

iABC will advance the development of two inhaled antimicrobials. BAL30072 is a novel antibiotic that is effective against a range of bacterial infections. The project will develop a version of the antibiotic that can be inhaled by patients with CF and BE. Studies will probe the safety of the inhaled antibiotic and determine the ideal dose. The project will also investigate the appropriate dose of tobramycin inhalation powder (TIP) in treatment of lung infections in BE patients and how safe and effective this dose is in these patients. TIP is currently only licensed for use in CF patients.

More broadly, the programme will undertake a number of activities designed to facilitate future research into and clinical trials involving CF and BE.  For example, part of the project is devoted to setting up an EU-wide registry of BE patients that would align new and existing national registries and facilitate the gathering of data on BE in Europe. This will aid in the identification of research needs, make it easier to identify patients who could be included in clinical trials, and guide the development of European guidelines for the management of BE.  iABC will ensure that the BE registry will remain viable after the end of the project.

Another project goal is to identify measures that could be used in clinical trials to assess the effectiveness of a medicine. These will include new ways of more accurately assessing lung function, DNA fingerprinting of bacteria, measurement of inflammatory biomarkers in the sputum and scoring CT (computed tomography) scans of the chest. The project will also study the nature and level of microbes found in the sputum.

New hope for patients

Just a few decades ago, most CF patients died in early childhood. Thanks to antibiotics, CF patients born today can expect to reach early middle age. However, this progress is threatened by the rise of antimicrobial resistance. The iABC project represents an important contribution to efforts to counter this threat.

Participants Show participants on map

EFPIA companies
  • Novartis Pharma AG, Basel, Switzerland
  • Polyphor AG, Allschwil, Switzerland
Universities, research organisations, public bodies, non-profit groups
  • Belfast Health and Social Care Trust, Belfast, United Kingdom
  • Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
  • Fundacio Hospital Universitari Vall D'Hebron - Institut De Recerca, Barcelona, Spain
  • Hospices Civils de Lyon (Lyon General Hospitals), lyon, France
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • Medizinische Hochschule Hannover, Hannover, Germany
  • Papworth Hospital NHS Foundation Trust, Papworth Everard, United Kingdom
  • Rijksuniversiteit Groningen, Groningen, Netherlands
  • Royal Brompton & Harefield NHS Foundation Trust, South Kensington, United Kingdom
  • Servicio Madrileno De Salud-Fibhug, Madrid, Spain
  • The Queen’s University of Belfast, Belfast, United Kingdom
  • Universitair Medisch Centrum Utrecht , Utrecht, Netherlands
  • Universitair Ziekenhuis Antwerpen, Edegem, Belgium
  • Universiteit Antwerpen, Antwerp, Belgium
  • University of Dundee, Dundee, United Kingdom
  • University of Edinburgh, Edinburgh, United Kingdom
  • Università degli Studi di Milano, Milano, Italy
Third parties
  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
  • Lothian Health Board, Edinburgh, United Kingdom
  • Université de Poitiers, Poitiers , France

CONTACT

Project coordinator
David Hughes
Novartis Pharma AG
david.hughes[at]novartis.com
Managing entity
Stuart Elborn
The Queen’s University of Belfast
s.elborn[at]qub.ac.uk