Alzprotect announces the extension of Phase 2a clinical trial for the treatment of progressive supranuclear palsy (PSP)
Lille (France), 16 February 2023 – Alzprotect, the French biopharmaceutical company, announces the extension of its Phase 2a clinical trials of its drug candidate for Progressive Supranuclear Palsy (PSP), a neurodegenerative disease similar to Alzheimer's disease, which severely impacts balance, eye movements, cognition and, in the more advanced stages of the disease, the ability to swallow.
The initial C04 study (a randomised, blinded study comparing two doses of AZP2006 to placebo) showed positive and promising results. These results have allowed Alzprotect to extend the trial for an additional six months for all eligible patients. Each of the primary objectives of the study were met, including high tolerability and safety for patients. In addition, there was evidence of interaction of the target protein, Progranulin, and promising signs of clinical efficacy.
The National Agency for the Safety of Medicines and Health Products (ANSM in French) and the Ethical Review Board (CPP in French) have given their approval for the extension, which should start in March and will be open-label (i.e. all patients will receive AZP2006 at a known dose).
Alzprotect will also conduct a larger pivotal clinical trial in early 2024, with the aim of accelerating the development of PSP treatment in Europe and the United States.
As Prof. Jean-Christophe Corvol, Professor of Neuropharmacology and Head of the Department of Neurology at the Pitié-Salpêtrière Hospital, points out: "The extension of this clinical phase 2a is good news for the patients who participated in it and will reinforce the promising results of the AZP2006 molecule developed by the Alzprotect teams. More generally, this decision represents additional hope for patients suffering from PSP, a rare and disabling neurodegenerative disease for which no treatment is currently capable of slowing down progression.”
Dr. Susanna Del Signore, Chief Medical Officer, added: "This agreement from the ANSM and the CPP underlines the sound clinical research methodology applied by the Alzprotect team, and will allow us to continue this research, building on the already consistent and informative initial results. This also reinforces the potential of our AZP2006 molecule as a potential treatment for PSP and other neurodegenerative diseases.”
Dr Philippe Verwaerde, Chief Executive Officer and President of Alzprotect, concluded: "The validation of the extension of the clinical Phase 2a represents a recognition of the outstanding scientific and operational work of the Alzprotect teams. This milestone is a further step towards the discovery of a potential treatment option for patients with PSP, as well as an opportunity to build on the positive results obtained to date. The extension will better prepare for the release of the Phase 2a study prior to the pivotal Phase II/III in Europe and the U.S., while supporting fundraising efforts in both markets to further develop treatments for patients with neurodegenerative diseases requiring treatment options.”