43rd Edition – February 2015

COMBACTE clinical trial of new antibiotic gets underway

The first patient has been enrolled into a clinical trial of a novel antibiotic run by IMI’s COMBACTE project. The patient, who is based in Belgium, is the first participant in a Phase II trial of a medicine called MEDI4893, which is designed to prevent Staphyolococcus aureus pneumonia in intensive care patients who need a machine to help them breathe. S. aureus is a common cause of hospital-associated infections and drug-resistant strains of the bacteria have been identified. MEDI4893, which was developed by pharmaceutical company MedImmune, works by targeting a toxin produced by S. aureus. The enrolment of the first patient in the trial is the result of months of hard work on the part of the project partners, who come from academia and industry and worked closely together to set up the study. ‘An increase in emergence of antimicrobial resistance and a steady decline in the number of novel antimicrobials being developed across industry have significantly limited treatment options for diseases like pneumonia caused by Staphylococcus aureus,’ said MedImmune’s Hasan Jafri, EFPIA Lead for the study.’ Novel biologics under investigation such as MEDI4893 may offer a unique opportunity to help prevent these serious infections without inducing antimicrobial resistance. We believe collaboration with world-renowned experts such as those within COMBACTE is one of the best models to advance development in this area, and supports our commitment to bring novel and effective anti-infectives to patients.’

Read the project’s press release. 

EU-AIMS study suggests eye movement in babies linked to autism risk

Babies who move their eyes more often when looking at a picture are more likely to go on to develop autism spectrum disorder (ASD) as children, according to new research supported by IMI’s EU-AIMS project. Although the research is in the early stages, the findings could help to identify babies at risk of ASD. In the study, scientists used eye tracking technology to assess how often babies aged six to eight months moved their eyes when looking at a (still) picture. Around half the babies in the study had an older sibling with ASD and so were at a higher risk of developing ASD themselves. The research revealed that while typical babies move their eyes on average twice a second, babies that went on to develop autism moved their eyes more often – around three times a second. Furthermore, typical babies assessed the picture in a similar way to adults, with an initial quick scan of the picture (with frequent eye movements) followed by a phase characterised by less frequent movements. In contrast, the babies at a higher risk of developing ASD did not change the way they looked at the picture over time.

Find out more in this Medical Research Council Press Release. 

Find out how the European Lead Factory can help you

IMI’s European Lead Factory project will demonstrate how its services can help to boost the drug discovery programmes of diverse organisations at a free workshop on 25 March at the SLAS Conference on Compound Management in Dortmund, Germany. The event will spotlight the extensive drug target screening and compound synthesis resources now available through the European Lead Factory. As such, it offers attendees an excellent opportunity to think about their target assay development and compound library design plans. Meanwhile the panel will be able to answer questions on the wider role of crowdsourced innovation and on working within extended public-private partnerships.

The European Lead Factory currently comprises a 350 000-compound screening collection originating from private partners or synthesised by public partners, as well as a screening centre that is accepting proposals for screening programmes. The first screens have already been completed and feedback from users is highly positive.

• Register to attend the workshop
• Find out how to submit a proposal for a target or scaffold
• Learn more about the European Lead Factory’s successes in its latest newsletter

IMI projects working on a new way of defining diseases

The work of IMI’s PRECISESADS and AETIONOMY projects on disease taxonomy is spotlighted in a new Nature Reviews Discovery comment piece. Currently, most diseases are still defined largely on the basis of their symptoms, yet while two patients may share the same diagnosis, the underlying causes of their symptoms may be very different. This means that a treatment that works in one patient may prove ineffective in another. The AETIONOMY and PRECISESADS projects are pioneering a new approach to the classification of disease; for AETIONOMY, in the field of Alzheimer’s and Parkinson’s diseases, and for PRECISESADS, in the field of systemic autoimmune diseases (such as rheumatoid arthritis and lupus). Although the projects are tackling the problem in different ways, their overall goal is the same: to pave the way towards a new taxonomy of disease that is based on the underlying causes of disease. In the long term, this will help to diagnose patients more accurately and provide them with a treatment that works for them.

NEWMEDS adds new features to DupCheck tool

IMI’s NEWMEDS project on schizophrenia and depression has developed a number of new features for its DupCheck tool, which allows those running a clinical trial in any area of medicine to check if a patient is already enrolled in another trial elsewhere. DupCheck works globally. The issue of duplicate enrolment in trials is important for patients and trial organisers alike. For patients, interactions between experimental drugs could be harmful and even fatal. For those running the clinical trial, avoiding multiple trial enrolments also helps to ensure the validity of the trial results – a patient could be given the placebo in one trial and an active ingredient for the same condition in another. Alternatively, if a patient is taking active treatments in two trials, both trials will attribute any improvements (or adverse reactions) to their own trial drug. In DupCheck, all patient data is encrypted and access to the site is restricted to those working on clinical trials.

DupCheck’s features now include:

• DupCheck provides real time information on attempted duplicate enrolment at time of screening.
• Users can screen for previous participation in a trial of investigational drug.
• DupCheck can be linked to existing electronic data capture systems—eliminating additional data entry—and run in the background.
• DupCheck provides sponsors with one-click, real-time data on screening by site.

Trial sponsors can enrol at www.dupcheck.org.

ENABLE Calls for antibacterial programmes: next deadline March 27

IMI’s antimicrobial resistance project ENABLE has a rolling programme of Open Calls for promising Gram-negative antibiotic programmes, and the next deadline for submissions is on 27 March 2015. If you have an interesting Gram-negative programme that targets Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and/or Acinetobacter baumannii and that meets the minimum activity thresholds specified within the call text, this is an opportunity to join the ENABLE project. Selected programmes can join the ENABLE consortium and gain access to the ENABLE discovery pipeline, which can develop a programme through to phase I clinical trials and significantly accelerate your work. Following earlier Calls, the project has started three programmes, with a further two due to start soon.

Details of how to apply can be found on the Open Calls page of the ENABLE website.

Questions? Contact opencall[AT]nd4bb-enable.eu.