Alzprotect Forges Ahead with First Patients Enrolled in Phase 2a Study in Progressive Supranuclear Palsy (PSP)
- Category: Small Molecules
- Published on Monday, 14 September 2020 11:37
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LILLE, France I September 14, 2020 I ALZPROTECT (http://www.alzprotect.com/en), 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. The number of PSP cases in Europe and the United States is estimated at 30,000 and 25,000, respectively. The average life expectancy of PSP patients ranges from 5 to 7 years. Alzheimer's disease is the most common form of dementia with an estimated 47 million patients worldwide in 2017, a figure that should increase to 75 million by 2030 or 132 million by 2050, according to the 2017 World Alzheimer Report.
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.
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.
EZEPROGIND is a bioavailable neurotrophic inducer. Unlike most products developed by the competition, EZEPROGIND targets all causes of neurodegeneration and is not only aiming at markers such as Abeta protein or Tau protein.