September, 18 2019
Lille (France), September 18, 2019 – ALZPROTECT, a biopharmaceutical company engaged in the development of drugs for the treatment of Alzheimer's disease, today announced that the French regulator has given the company permission to launch a phase 2a clinical trial with its drug candidate AZP2006 in Progressive Supranuclear Palsy (PSP), an orphan disease for which the company had already been granted the “orphan drug” status by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Phase 2a study with AZP2006 in PSP
Just approved by the French Agency for the Safety of Health Products (Agence nationale de sécurité du médicament et des produits de santé – ANSM), this study will be conducted at the Pitié-Salpêtrière University Hospital in Paris, under the leadership of Professor Jean-Christophe Corvol, and at the University Hospital of Lille, France, in the unit of Professor Luc Defebvre. This clinical trial will aim to evaluate the tolerability of the product in PSP patients; to strengthen the pharmacokinetic data of the product in patients after 3 months of treatment; and to evaluate the impact of the treatment on the disease’s 20-plus biomarkers. This phase 2a study should be completed by the end of 2020, and its first results will be published in 2021. As part of the study, 36 PSP patients will receive alternatively a placebo or one of two AZP2006 doses (60 and 80, then 50 milligrams). AZP2006 will be administered orally for 3 months, followed by an additional 3-month weaning observation period.
Philippe Verwaerde, Chairman and CEO of Alzprotect said: “The launch of phase 2a trials with AZP2006 is a significant step forward for Alzprotect. We are pleased to advance the development of our drug candidate in PSP according to schedule. As PSP keeps evolving, this is a promising treatment to address the growing, unmet medical needs of patients suffering from this orphan disease, for which no treatment currently exists.”
“AZP2006 is the result of intense research centered on a unique and highly promising mechanism of action. Patients are eager to have access to a neuroprotective treatment. As for us, we are impatient and extremely committed to start this study,” said Dr. David Devos, Professor in Neuropharmacology at the University Hospital of Lille, INSERM U1171.
"This phase 2a milestone rounds off years of research efforts by Alzprotect. The first administration of AZP2006 in PSP patients will reward the remarkable work done by our team so far. We are looking forward to the results of this trial and are already planning the next steps for the development of AZP2006 in other neurodegenerative diseases,” said Noelle Callizot, Director of Pharmaceutical Development at Alzprotect.