Alzprotect forges ahead with first patients enrolled in Phase 2a study in Progressive Supranuclear Palsy (PSP)
Lille (France), September 14, 2020 – ALZPROTECT, a biopharmaceutical company developing treatments for Alzheimer’s disease, today announced the recruitment of the first 5 patients to participate in its phase 2a clinical trial with its drug candidate AZP2006 (named EZEPROGIND by WHO) in Progressive Supranuclear Palsy (PSP), an orphan disease for which the company has been granted with the “orphan drug” status by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
With EZEPROGIND, Alzprotect is targeting two neurodegenerative diseases: Progressive Supranuclear Palsy (PSP), for which there is no treatment to date, and Alzheimer's disease, a major public health issue with no reliable early diagnosis or treatment currently able to change the course of the disease.
These first patients were recruited at the two French hospitals where the phase 2a study are conducted: the Pitié-Salpêtrière University Hospital of Paris, under the leadership of Professor Jean-Christophe Corvol, and the University Hospital of Lille, in the unit of Professor Luc Defebvre.
Phase 2a study with EZEPROGIND in PSP
The primary objectives of this clinical trial are to evaluate the tolerability of the product in PSP patients; to strengthen the pharmacokinetic data of the product after 3 month-treatment; and to evaluate the impact of the treatment on the disease’s markers (more than 20 of them, targeting inflammation and neurodegeneration). This Phase 2a study should be completed by the end of 2021, and the first results should be published in 2022. As part of the trial, 36 PSP patients will receive a placebo or one of two AZP2006 doses. AZP2006 will be administered orally for 3 months, followed by a 3-month observation period.
“As investigators at the University Hospital of Lille, we’re extremely satisfied with the enrollment of these first patients and eager to move forward with the trial. EZEPROGIND's innovative mechanism of action is very promising and could provide a treatment for patients who currently have no solutions available to them,” said Prof. Luc Defebvre of the University Hospital of Lille.
“Therapeutic innovation is essential in neurodegenerative diseases, and EZEPROGIND is a promising treatment strategy for patients suffering from PSP, a rare disease whose progression cannot be slowed down by any available treatment today,” said Dr. Jean-Christophe Corvol, Professor of Neuropharmacology and Head of the Center for Clinical Research in Neuroscience at the Pitié-Salpêtrière University Hospital.
“The enrolment of these first patients is a key millstone in the development of AlzProtect. Our study design was approved by health authorities, stressing the need for new treatment options in neurodegenerative diseases and the interest garnered by our approach. As studies on molecules based on antibodies in Alzheimer's disease have been stopped, EZEPROGIND is an extremely promising treatment for patients suffering from this disease, for which there is currently no therapeutic solution. We expect to move on swiftly with the remaining patients, which would allow us to complete the recruitment on schedule,” said Philippe Verwaerde, CEO of Alzprotect.