AlzProtect obtains authorization to start a Phase 2a clinical trial in PSP
AlzProtect, a biopharmaceutical company engaged in the development of drugs for the treatment of Alzheimer's disease, announces today, September 18, 2019 that the ANSM has authorized the launch of a phase 2a clinical trial with the drug candidate AZP2006 in the indication of Progressive Supranuclear Paralysis (PSP), an orphan disease for which the company has obtained the status of "orphan drug" from the Food and Drug Administration (FDA) and the European Medicines Agency.
Phase 2a study with AZP2006 in PSP
This study will be conducted at Hospital "La Pitié Salpêtrière" in Paris (AP-HP), under the supervision of Professor Corvol and at the Lille University Hospital, in the department of Professor Defebvre. The objectives of this clinical trial are to verify the tolerability of the product in PSP patients; to strengthen the pharmacokinetics data of the product in patients after 3 months of treatment but also to assess the impact of treatment on markers of the disease (more than 20 markers). Phase 2a should be completed at the end of 2020 for the publication of the first results in 2021. During this phase 2a study, 36 PSP patients will alternately receive a placebo, or one of the two doses of AZP2006 (60 and 80 -then-50 milligrams). AZP2006 will be administered orally for 3 months, an observation period of 3 additional months (withdrawal) will be carried out.
"The start of this phase 2a study is an opportunity for patients suffering from PSP, a rare disease for which no treatment is currently able to slow down progression", underlines Pr. Jean-Christophe Corvol, Professor in Neuropharmacology and head of the Center for Clinical Research in Neuroscience at La Pitié-Salpêtrière.
"AZP2006 is the result of intense research with a unique and very promising mechanism of action. Patients are desperate for neuroprotective treatment. We are impatient and very mobilized to begin this study ", specifies Pr David Devos Professor in Neuropharmacology at the University of Lille, Lille University Hospital, INSERM U1171.
Philippe Verwaerde, CEO of AlzProtect said: "The entry into phase 2a of our drug candidate AZP2006 is an important step for AlzProtect and we are delighted that its advances in PSP are continuing as anticipated. PSP continues to progress and we have a promising treatment for patients suffering from this disease knowing that there is no treatment to date and that the unmet medical needs of this orphan disease are growing."
"This entry into phase 2a crowns the many years of research carried out by AlzProtect, this first administration in the PSP patient is the reward for the remarkable work carried out by the team. We are impatiently awaiting the results of this trial and are already preparing the next steps in the development of AZP2006 in other neurodegenerative diseases, "said Noelle Callizot, Director of Pharmaceutical Development, AlzProtect.