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New Alzheimer’s drug PRI-002 receives EMA approval for Phase II study

Press release from 20 November 2023

Priavoid GmbH and PRInnovation GmbH announce today that the European Medicines Agency (EMA) has granted approval to conduct a Phase II clinical trial for the drug candidate PRI-002 to combat Alzheimer’s disease.

The study, which is named PRImus-AD, is being conducted by PRInnovation as sponsor in close collaboration with Priavoid and is funded by the German Federal Agency for Disruptive Innovation SPRIND with funds from the German Federal Ministry of Education and Research. The objective of the study is to demonstrate the efficacy of PRI-002 in patients with early-stage Alzheimer’s disease as well as to further substantiate its safety profile, which was already shown to be convincing and beneficial in
three Phase I studies. To this end, PRI-002 is being tested in a placebo-controlled Phase II study in 270 patients across initially six European countries.

The scientific basis for the study is a purely physical mechanism of action by which neurotoxic
aggregates (“oligomers”) of the Abeta protein are directly broken down into their individual, harmless building blocks (“monomers”) and without the intervention of the immune system. PRI-002 thus fundamentally differs from antibody-based drug candidates that are currently applying for drug approval.

There are high hopes for the Phase II trial, which has now been approved, given that there are around 1.1 million Alzheimer’s patients in Germany alone for whom no effective, disease-modifying and safe drugs have been approved to date.
Philipp Bürling, CEO of Priavoid GmbH, commented on the approval: “Phase II is groundbreaking for us as a company, but also for millions of people affected worldwide.”

Prof. Dr. Dieter Willbold, co-founder of Priavoid adds, “After decades of setbacks in drug development, there has been some positive news recently. We can’t wait to get started with the trial.”

And PRInnovation GmbH, which was founded by SPRIND specifically for the purpose of conducting this study, has also reached an important milestone. Dr. Kathrin Thiem, Co-CEO of PRInnovation, says: “SPRIND’s mission is to fund projects with disruptive potential that have a major benefit for humanity – but for which there is no private-sector funding. If we can show the efficacy of PRI-002 in this study, this is without any doubt a disruptive innovation.”

Results for this study are expected in 2026. The aim is then to move seamlessly into a corresponding pivotal Phase III study.

 

More information can be found here.