Study to Evaluate Safety and Efficacy of Drug Seeking to Treat Those with Mild Cognitive Impairment or Mild Dementia

HALLE (SAALE), Germany and San Diego, CA – USA, 20 March 2019 – Probiodrug AG, a clinical stage biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer’s disease (AD) (Euronext Amsterdam: PBD) and the Alzheimer’s Disease Cooperative Study (ADCS), announced today that the National Institutes of Health (NIH) is funding in part a US Phase 2b core program to evaluate the efficacy and safety of Probiodrug’s PQ912 in patients with mild cognitive impairment (MCI) or mild dementia due to AD with an NIH Research Project (R01) grant expected to total 15 million USD over four years.

The grant was awarded by the National Institute on Aging, part of the NIH, for the project A Seamless Phase 2A-B Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PQ912 in Patients with Early Alzheimer’s Disease. The funding is under award number R01AG061146 to the University of California, San Diego.

Probiodrug is the sponsor of the U.S. study led by study principal investigator Howard Feldman, MD, Director of the ADCS, a national consortium of clinical sites, based at the University of California, San Diego.

“We are very grateful to the NIH for supporting this research which will advance a novel experimental therapeutic approach for those suffering from mild cognitive impairment and mild dementia due to early Alzheimer’s,” said Howard Feldman, MD, Professor of Neurosciences and Director of the ADCS, based at the University of California, San Diego. “This new medication PQ 912 will allow us to target several disease mechanisms, including the buildup of a particularly toxic form of amyloid beta peptides as well as the modulation of the neuroinflammatory process that occurs in the disease. We look forward to being able to measure the sufficiency of dosing, against the disease targets, an opportunity we often do not achieve in clinical trials and which will help definitively address whether this approach works.”

The study is designed as a randomized, double-blind, placebo-controlled trial evaluating 460 study participants from centers in the U.S. and Canada. Patients will be treated 1:1 with either PQ912 – a specific small molecule inhibitor of Glutaminyl-Cyclase – or with a placebo, for a duration of 18 months.

“We strongly believe in our first-in-class approach for early Alzheimer’s disease intervention and hope that the funding awarded by the NIH in PQ912 will motivate other investors to support us in this important research,” said Dr. Ulrich Dauer, CEO of Probiodrug. “The support of the NIH will provide important data for our therapeutic concept.”

The NIH grant will partially fund the U.S. study and the remaining budget will be covered by Probiodrug.

* The content of this press release is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.

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