NEWMEDS unites researchers to speed the quest for schizophrenia and depression treatments

Schizophrenia affects around 24 million people worldwide, and depression up to 15 times as many, according to the World Health Organisation. However, few truly game-changing medications have reached the market in the last few years. IMI's NEWMEDS project brings together seven academic research institutions, nine major pharmaceutical companies and three small and medium-sized enterprises (SMEs) with the goal of overcoming the hurdles that are slowing research and development, and smoothing the path to market for treatments of these disabling mental disorders. The project has made a number of breakthroughs. For example, clinical trials in which patients on active treatment are compared to patients taking a placebo normally take six weeks. However, NEWMEDS has found that these trials could be shortened by a week or two. NEWMEDS research also suggests that more women should be included in trials; currently they account for under a third of trial participants yet they respond less to placebos than men.

These results were made possible because the companies involved in NEWMEDS have pooled their data to create the largest known database of studies on schizophrenia, including information on over 23 000 patients from 67 studies in over 25 countries. The database offers the industry and the academic community unique opportunities for the development of tools and models that will help find targeted treatments for schizophrenia.

An analysis of this data also revealed that so-called negative schizophrenia symptoms (e.g. an inability to feel pleasure or act spontaneously) could respond better in these studies than was previously thought, something that has been largely overlooked before.

In addition, the project is shedding new light on the complex biology of schizophrenia and depression. The teams are applying this information to develop animal models that use brain imaging and behavioural tests to bridge the gap between animal studies and human clinical trials. The genetics of schizophrenia are also key to the project; people whose parents both have schizophrenia have a 50% chance of developing the disease themselves. For people with no family history of schizophrenia, that figure is just 1%.

The project’s Academic Lead, Professor Shitij Kapur, MBBS, PhD, FMedSci and Dean of the Institute of Psychiatry, King’s College London, commented: "NEWMEDS is studying genetic risk factors for schizophrenia called ‘copy number variations’ both in animal models and humans. The results of these studies will help to determine which changes and mechanisms in the brain are caused by these factors, paving the way to the development of new treatments."

The project is also hunting for biomarkers that could be used to signpost early signs of efficacy in new drugs tested in healthy volunteers, or to match patients with the most effective drugs.

Project Coordinator Tine Bryan Stensbøl, Divisional Director, Discovery Pharmacology Research, H. Lundbeck, said: "Neither schizophrenia nor depression are a single entity, and in both disease areas only certain patients respond to certain medications. Different groups of patients should be treated in different ways, and the NEWMEDS project could give us the tools to find new drugs and test them in the patients most likely to respond."

These findings, and other new approaches to clinical trials that are in development with the NEWMEDS researchers, could lead to shorter human studies involving fewer people, which would get drugs to the market faster and more cost-effectively.

IMI Executive Director Michel Goldman said: "NEWMEDS exemplifies how, by pooling existing data, organisations can make discoveries that have a profound impact on drug research and development and could really help to get new drugs to where they are most needed - the patient."

This work is part of the Innovative Medicines Initiative (IMI), a collaboration between the European Union and the pharmaceutical industry. By supporting the exchange of knowledge and expertise among companies and between public and private partners, IMI is generating achievements and taking on research challenges that are too great for any individual company or organisation to tackle alone. The ultimate goal of IMI is to speed up the development of safer and more effective medicines for patients.

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About the NEWMEDS project
NEWMEDS brings together seven academic research institutions, nine major pharmaceutical companies and three small and medium-sized enterprises into one consortium to overcome three major bottlenecks in developing models and methods in drug discovery as they relate to schizophrenia and depression. The aim is to develop more accurate animal models to guide drug discovery; create tools and tests that can show early signs of efficacy in studies in healthy volunteers; and revise clinical trial methodologies that have remained unchanged for many years.

About IMI
The Innovative Medicines Initiative (IMI) is the world’s largest public-private partnership in health care. IMI is improving the environment for pharmaceutical innovation in Europe by engaging and supporting networks of industrial and academic experts in collaborative research projects. The European Union contributes €1 billion to the IMI research programme, which is matched by in kind contributions worth at least another €1 billion from the member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

The Innovative Medicines Initiative currently supports 40 projects, many of which are already producing impressive results. The projects are all working to address the biggest challenges in drug development, to accelerate the development of safer and more effective treatments for patients.