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New Milestone Achieved in Jülich Alzheimer’s Treatment

Drug candidate PRI-002 now being tested further in Vienna

Jülich/Vienna, 8 January 2019 – The Alzheimer’s drug candidate PRI-002, which was developed at Forschungszentrum Jülich, is entering the next clinical trial phase: on 8 January, the first healthy test subjects were given their first daily dose of the drug, marking the beginning of clinical phase Ib of the study. The aim is to demonstrate the safety of the drug candidate throughout four consecutive weeks of daily administration.

"In summer 2018, the safety and tolerance of the drug candidate PRI-002 – even at the highest planned dosage – was demonstrated by means of a one-off administration to healthy individuals," says Dieter Willbold, who heads Jülich's institute of Structural Biochemistry.

Clinical trials are strictly regulated and have to be conducted according to precisely defined specifications to ensure both the safety of the test subjects and the reliability of the results. The next stage of the trial involves administering the drug to healthy individuals at various dosages over a period of up to four weeks. At the Department of Clinical Pharmacology of the Medical University of Vienna, the study is being supervised by Prof. Michael Wolzt in close coordination with Dr. Dagmar Jürgens from Jülich’s Institute of Complex Systems – Structural Biochemistry. The Austrian contract research organization NeuroScios GmbH – an institution with years of experience in clinical research into diseases of the central nervous system – is also a partner. As during the first stage of the study, NeuroScios is continuing its participation by assisting with clinical monitoring and correct implementation on behalf of Jülich. The development of the drug candidate at Forschungszentrum Jülich has so far been funded from the Helmholtz Validation Fund. This newly launched study is additionally supported by funds from the US-based Alzheimer’s Association.

PRI-002 is one of a completely new type of active substances that are based on D-enantiomeric peptides, or "D peptides" for short. But this is not the only thing that is new: in contrast to previous drug candidates, PRI-002’s mechanism of action involves directly targeting the toxic Aβ oligomers, which play a central role in the disease.

Preclinical tests on PRI-002 have revealed additional promising properties that favour its use as a drug. Oral administration of the drug led to improved cognitive performance in mice displaying symptoms similar to Alzheimer's. "Oral administration is a gentle method and therefore attractive – a massive advantage when it comes to older patients in particular," says Willbold.

After successful tests with single and multiple increasing doses of PRI-002 have been completed in healthy volunteers, the researchers can apply for and conduct a clinical phase II study that will test the efficacy of the drug in Alzheimer’s patients. "Such a study will be a lot more comprehensive," says Willbold. "We will need investors or partners to carry it out.” To lay the foundations for this, the researchers founded Priavoid GmbH as a spin-off of Forschungszentrum Jülich and Heinrich Heine University Düsseldorf (HHU) in September 2017. Priavoid will take over the further clinical development of PRI-002 once the current study is concluded.

Opens new windowThe formation and aggregation of the amyloid beta protein is a complex process.
Copyright: Illuteam43

Schematische DarstellungMechanism of action: In the brain, the Aβ peptide is cut out of a larger protein molecule by enzymes. As Alzheimer’s disease progresses, single Aβ monomers combine to form oligomers and fibrils.
Copyright: Tricklabor

Further information:

About Priavoid

Priavoid GmbH is a biopharmaceutical company founded in September 2017 as a spin-off of Forschungszentrum Jülich and Heinrich Heine University Düsseldorf.
The company develops and markets innovative drug candidates based on D-peptides for the treatment of neurodegenerative disorders such as Alzheimer’s, Parkinson’s, ALS, Huntington’s chorea, and various tauopathies. The most advanced drug candidate is PRI-002, which was developed to treat Alzheimer’s and is about to be tested further in humans. The company’s headquarters are in Jülich.
www.priavoid.com

About NeuroScios

NeuroScios is a full-service clinical contract organization specializing in studies in the field of neurodegenerative disorders. The company boasts more than 30 years of cumulative experience in this indication area and has had international responsibility conducting approximately 40 studies from phase I to phase III. Detailed knowledge of indications, excellent connections to key opinion leaders, and understanding of the latest research form the basis for the work conducted by NeuroScios. The company’s headquarters are in Sankt Radegund bei Graz, Austria.
www.neuroscios.com

Video interview on the foundation of Priavoid GmbH with PharmaVentures (November 2017)

Opens new windowZum Anschauen des Videos bitte auf das Bild klicken.
Copyright: www.pharmaventures.com

https://www.biotechandmoney.com/blog/interview-with-priavoids-dieter-willbold

Web story on Jülich’s research into Alzheimer’s disease:
"Alzheimer’s disease – pieces of the puzzle fall into place"

Alzheimer’s cover story in Forschungszentrum Jülich’s effzett magazine, issue 2/18:
"Starting Over?"

Alzheimer’s disease at Forschungszentrum Jülich (in German)

Press release on study approval:
"Phase I Clinical Trials Approved for Alzheimer’s Drug Candidate" (from 20 March 2018)

Press release on the founding of Priavoid:
"Entrepreneurs Develop Drugs Against Alzheimer’s" (22 September 2017)

Image on homepage: Example image of a medication. Copyright: CC 0 Creative Commons.

Contacts:

Dr. Dagmar Jürgens
Institute of Complex Systems, Structural Biochemistry (ICS-6)
Tel.: +49 2461 61-2751
Email: d.juergens@fz-juelich.de

Prof. Dieter Willbold
Director at the Institute of Complex Systems – Structural Biochemistry (ICS-6)
Tel: +49 2461 61-2100
E-Mail: d.willbold@fz-juelich.de

Press contact:

Annette Stettien
Corporate Communications
Tel.: +49 2461 61-2388
Email: a.stettien@fz-juelich.de