DZNE reinforces its study resources at several sites
DZNE is augmenting its nationwide infrastructure for clinical research with the construction of new facilities at several sites. To this end, the Helmholtz Association is providing around 35 million euros. This is intended to expand the capacities for interventional trials and advance the development of drugs against neurodegenerative diseases such as Alzheimer’s, Parkinson’s and ALS.
Neurodegenerative diseases can cause dementia, trigger movement disorders and massively impair health also in other ways. In Germany, more than two million people are currently living with these effects. As yet, there is no prospect of cure or at least of stopping the disease process. Current therapies can only alleviate symptoms and somewhat slow down disease progression. “We urgently need more effective drugs against dementia and other consequences of neurodegeneration,” said Prof. Pierluigi Nicotera, Chairman of DZNE’s Executive Board. “The expansion of DZNE’s clinical network, which has now been approved, creates a multisite infrastructure for early interventional trials with promising agents that will be tested for the first time in humans. In the field of neurodegenerative diseases, this is unparalleled in Germany and internationally. This is an important step in accelerating the search for therapies against neurodegeneration. There is no doubt that industry plays an important role in drug development. However, on the part of science, we must drive this development and take the initiative.”
Expanding Established Resources
At five DZNE sites – in Dresden, Magdeburg, Munich, Rostock and Tübingen – new buildings with so-called Clinical Trial Units (CTUs) will be constructed by 2028, equipped with rooms for treatment, facilities for inpatient monitoring and the necessary medical equipment. Together with the existing CTU in Bonn and facilities at DZNE’s Ulm site, this will establish a nationwide network for testing innovative therapeutic approaches. A new chapter is thus being opened, because until now DZNE has had to focus mainly on observational trials. Such studies are concerned, for example, with early detection or with understanding disease progression. “For years, we have been conducting inter-site studies together with local university hospitals. To this end, we have set up a highly effective study management that ensures examinations according to uniform criteria at all sites,” explained Prof. Thomas Klockgether, Director of Clinical Research at DZNE. “However, our options for interventional studies have been very limited up to now. They will now be significantly expanded. For the operation of the newly created CTUs, we will continue to work closely with the local university hospitals.”
First-in-human Studies
DZNE will focus on so-called phase I and phase II trials. Such clinical studies, in which agents are tested on humans for the first time, are important steps on the path to new drugs. Frequently, they are run by research institutes. Pharmaceutical companies mainly focus on later phase III trials as they often consider the chances of success in early trials to be too uncertain. “We want to test new compounds that have yielded promising results in the laboratory on small groups of people. On our own or with financial support from the pharmaceutical industry. Generally, our aim is to initiate developments where industry may still be hesitant,” said Klockgether. DZNE is already collaborating with pharmaceutical companies and expects the expansion of its clinical network to provide a significant boost to such ventures. “The resources that are now being created make DZNE even more attractive as a partner for industry collaborations. Because in addition to scientific expertise, we can now also contribute an excellent infrastructure for interventional studies. This is very important for Germany as a hub for research.”
Stratification as a Key Factor
More than 8,000 individuals are currently enrolled in DZNE studies. Participants in interventional studies could be recruited from this large collective. In addition, there is another asset: so-called stratification, whose potential has not yet been fully utilized. Until now, most interventional studies on neurodegenerative diseases have included participants on rather broad bases. However, it is becoming increasingly clear that there are individual differences in many neurodegenerative diseases and that treatment should also be based on the stage of disease. “The bottom line is that you have to classify patients into groups according to scientific criteria and tailor therapy to these groups for the best possible chances of success,” Klockgether explained. Such a categorization – called “stratification” – is a standard procedure at DZNE, as participants in clinical studies are comprehensively characterized medically. “Insofar, on the one hand, we have a large pool of potential study subjects, since we conduct research across sites and are not limited to local collectives. On the other hand, our study subjects are stratified. Taken together, these are very good premises for testing new agents and providing significant momentum to drug development. This gives us the opportunity to play at the top internationally,” said Klockgether.
© DZNE/Frommann
