Welcome to the first newsletter of the Inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis (iABC) project. The newsletter will keep interested parties up to date with recent developments within the project, and will highlight any forthcoming events and activities that may be of interest to you.
About IMI, ND4BB and EFPIA
iABC is an IMI/EFPIA co-funded project and part of the European New Drugs for Bad Bugs (ND4BB) initiative.
In November 2011, the European Commission launched its Action Plan against the rising threat from Antimicrobial Resistance, and called for "unprecedented collaborative research and development efforts to bring new antibiotics to patients." The New Drugs for Bad Bugs (ND4BB) program was launched within the Innovative Medicines Initiative (IMI) in direct response to this call. IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA); it constitutes Europe's largest public-private initiative aiming to accelerate the development of better and safer medicines for patients. The EFPIA brings together 33 European national pharmaceutical industry associations as well as 40 leading companies undertaking research, development and the manufacture in Europe of medicinal products for human use (www.efpia.eu).
What is the iABC Project?
Chronic respiratory infections, frequently caused by multidrug-resistant bacteria, are the main cause of disease worsening and decreased survival in patients with cystic fibrosis (CF) and bronchiectasis (BE). Inhaled antibiotics are thought to be a better approach to reduce the risk of exacerbation and prevent lung function decline as opposed to systemic treatments. Median life expectancy is now longer than ever before and patients enjoy a better quality of life. However, pathogens responsible of infections are increasingly becoming resistant to the few drugs available, putting patients' lives at risk. Additionally there is currently no approved drug for the treatment of chronic infections in patients with BE.
iABC is advancing the development of two inhaled antibiotics treatments for patients with CF and BE, and will also establish the first European patient register for bronchiectasis. It is also working to identify ways of improving clinical trials standards to better manage the symptomatic treatment of these two serious diseases.
Launch of the iABC Project
The iABC project began its programme in August 2015 with the aim to develop two new inhaled antibiotics therapies to manage chronic lung infection in CF and BE patients, a dry powder formulation of tobramycin and BAL30072, an investigational monosulfactam antibiotic with in-vitro and in-vivo activity against many clinically relevant multidrug-resistant Gram-negative bacteria.
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 (AMR). Moreover, etiology in patients with bronchiectasis is still not clearly defined and comprehensive data are still lacking. The iABC project represents an important contribution to efforts to counter this threat.
The iABC project has made good progress since its launch in September 2015: committee structures are well established and meet regularly, work packages have begun their activities, and advancement towards clinical trials has started. There is an exciting schedule of work planned for the future and we look forward to seeing the progress in the forthcoming months.
First Clinical Trials Imminent
We aim to start the first of the project's clinical trials in June 2016. This Phase II, randomised, double blind, placebo controlled study will investigate the efficacy and safety of tobramycin in BE patients with a history of exacerbations and chronic Pa infection. It will also examine dosage and frequency of treatment.
This Novartis led study will involve 180 patients from 50 different sites across Europe. . On successful completion of the phase II study, recruitment will begin for phase III which will include patients from the USA.
Preparations for this study are well under way, with a CRO appointed and multiple trial sites already identified
One of the additional goals of the iABC project is to develop an EU‐wide BE registry which provides a platform for the development of the European bronchiectasis clinical trials network. This activity which is led by the University of Dundee has the ambitious target of enrolling 10,000 patients over 5 years, is already well on track with over 2000 patients currently registered.
Who is involved in the iABC project?
The iABC consortium consists of partners from 8 different countries across Europe. Here is a full list of all those involved:
Basilea Pharmaceutica International AG, Switzerland
Novartis Pharma AG, Switzerland
Universities, research organisations, public bodies, non-profit groups
Belfast Health and Social Care Trust
Consorci Institut d'Investigacions Biomèdiques August Pi i Sunyer
Erasmus Universitair Medisch Centrum Rotterdam
European Cystic Fibrosis Society
European Respiratory Society
Fondazione Irccs ca' Granda Ospedale Maggiore Policlinico
Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
Hospices Civils de Lyon (Lyon General Hospitals)
Hospital Clínic i Provincial de Barcelona
Institut National de la Santé et de la Recherche Médicale
Medizinische Hochschule Hannover
Papworth Hospital NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
Servicio Madrileno de Salud
The University of Edinburgh
The Queen's University of Belfast
Università degli Studi di Milano
Universitair Ziekenhuis Antwerpen
Université de Poitiers
University Medical Center Utrecht
University of Antwerp
University of Dundee
Upcoming meeting of interest
39th European Cystic Fibrosis Conference, June 8-11 2016, Basel, Switzerland