The European Union’s Innovative Medicines Initiative (IMI) has launched its 8th Call for projects addressing challenges in drug development.

The new call allocates €242.7 million in total to fund proposals centred on antimicrobial resistance, disease classification and access to stem-cell lines.

The IMI is providing €143.3 million in cash for the latest proposals, which come with an application deadline of 19 March 2013.

The remaining €99.4 million is an in-kind contribution from member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA) participating in the Innovative Medicines Initiative.

Antimicrobial resistance

The 8th Call adds two topics to IMI’s antimicrobial resistance programme (NewDrugs4BadBugs/ND4BB), which is part of the European Commission’s antimicrobial resistance Action Plan.

The first new topic in this field focuses on innovative clinical-trial design and drug development.

It complements one of the ND4BB topics launched last May by seeking proposals for clinical trials that support the development of MEDI4893, a monoclonal antibody targeted at Staphylococcus aureus alpha toxin.

The Staphylococcus aureus bacterium is the leading cause of antibiotic-resistant healthcare-associated infections worldwide, IMI notes. 

Unique opportunity

The second antimicrobial resistance topic is aimed at developing new drugs to treat Gram-negative bacteria, such as Escherichia coli.

This project offers “a unique opportunity for universities and small companies to access the expertise and resources available under a newly-created drug discovery platform to advance their candidate drug molecules”, IMI says.

Drug resistant Gram-negative bacteria are responsible for two thirds of the 25,000 reported deaths attributed to antimicrobial resistance in Europe each year, IMI points out.

“With cases on the rise, new antibiotics are urgently needed to treat these infections,” it adds.

Disease taxonomy

Two of the 8th Call topics are designed to “pave the way for a major rethink” in the way diseases are classified (disease taxonomy).

At present, diseases are defined largely on the basis of symptoms and their location in the body, IMI explains.

There is, however, growing evidence that while two patients may have the same diagnosis, “the genetic/molecular causes of their symptoms may be very different”, it notes. “This means that a treatment that works in one patient may prove ineffective in another.”

Accordingly, here is now broad recognition that disease taxonomy needs to be revised. Given the “immense scale” of this challenge, only a large public-private partnership can take it on, IMI says.

The 8th Call topics will embark on a new approach to disease taxonomy, focusing initially on two areas where the problems of patient classification are well known: immuno-inflammatory disorders (e.g. systemic lupus erythematosus and rheumatoid arthritis) and neurodegenerative diseases (particularly Alzheimer’s and Parkinson’s disease).

The projects will deliver data, tools and recommendations that can be used by the biomedical community to develop new treatments and diagnostic tests.

Stem cell bank

The third issue addressed under the 8th Call is the “urgent” need for a European induced pluripotent stem-cell (iPS) bank

Researchers are generating large volumes of iPS cell lines, but the quality of these lines varies greatly and they do not always provide sufficient data on the donor for researchers to make optimal use of them, IMI observes. Moreover, access to cell lines is often highly restricted.

This topic foresees the creation of a European iPS cell bank that would provide researchers with access to quality-assured, well characterised iPS cell lines on a not-for-profit basis.