- April 19, 2018
- Posted by: PharmaScroll
The Phase I clinical study, in which the Jülich Alzheimer’s drug candidate PRI-002 is being tested for the first time in humans, has now officially started in Vienna. On Monday, PRI-002 was administered to the first healthy volunteer. The study will evaluate the safety and tolerability of the oral dosage form of PRI-002 in healthy volunteers. Prof. Dieter Willbold, developer of PRI-002 and director of the Jülich Institute of Structural Biochemistry, was present in Vienna while the Phase I study started.
“We and our partners worked hard to prepare the study in the most careful and best possible way,” says Dieter Willbold. Clinical trials are strictly regulated and have to be conducted according to clearly defined guidelines to ensure both the safety of participants and the reliability of results. On site at the Department of Clinical Pharmacology, the study is supervised by Prof. Dr. Michael Wolzt at the Medical University of Vienna, in close coordination with Dr. Dagmar Jürgens, Institute of Structural Biochemistry, from the side of the research centre. Another partner is Neuroscios GmbH, a contract research organization based in Austria with many years of experience in clinical research for diseases of the central nervous system. The company has been commissioned to contribute to clinical monitoring and the correct conduct of the study.
Prof. Sebastian Schmidt, Board Member of Forschungszentrum Jülich, highlights the significance of the move into the clinic: “It is always our goal not only to increase knowledge with our work, but also to make concrete contributions to the benefit of people. There is hardly a better example of this than the new therapeutic perspective against Alzheimer’s disease”.
PRI-002 belongs to a completely new class of active compounds based on so-called D-enantiomeric peptides or “D-peptides” for short. This class of substance has never been administered to humans before. Such “first-in-class” drugs are extremely rare: “Worldwide there are only a few tests with really fundamentally new substance classes in humans per year,” says Dagmar Jürgens. The mechanism of action is also new: Unlike previous drug candidates, PRI-002 specifically and directly eliminates so-called Amyloid-beta oligomers, which play a central role in disease processes.
Preclinical tests with D-peptides have shown additional favorable properties: A big advantage is that they are very stable in the body – this allows oral application as simple tablet or capsule. “Oral application is very attractive and would be of great advantage, especially for older patients,” says Willbold. Oral application of PRI-002 in mice with Alzheimer-like symptoms has reliably yielded significant cognitive improvements.
Now the positive results for safety and tolerability from preclinical studies need to be confirmed in humans. Then beneficial efficacy can be tested in Alzheimer’s patients. “Such a study would have a much larger scale,” says Willbold. “We are going to need investors or partners.” In order to lay the foundations for this, the researchers founded the spin off company Priavoid GmbH out of Research Centre Jülich and HHU Düsseldorf in September 2017.
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News Source: Jülich Website
Image Source: https://www.alzheimers.net/clinical-trials/