Alzprotect announces the completion of clinical trial phase 2a for the treatment of Progressive Supranuclear Palsy (PSP)
Lille (France), 20 September 2022 – On the eve of world Alzheimer’s day, Alzprotect, a biopharmaceutical company developing treatments for neurodegenerative diseases, announces the completion of the phase 2a clinical trial evaluating its platform asset, AZP2006 (“EZEPROGIND”) in Progressive Supranuclear Palsy (PSP), a rare neurodegenerative disease, sharing key features with Alzheimer’s disease, and which seriously impacts balance, eye movement, cognition, and in the latter stage of the disease, the ability to swallow.
The clinical trial, which is part of a multi-indication development plan for AZP2006, was conducted at the Pitié-Salpêtrière University Hospital of Paris, the University Hospital of Lille, and the Hospital Foundation Adolphe de Rothschild on 36 patients whose recruitment was successfully completed in January.
The primary objectives of the study were met, namely the investigational product good safety and tolerability in PSP patients. Clinicians were satisfied with symptom changes. The results of CSF and plasma biomarkers and clinical exploratory endpoints will be reported later this year.
This success allows Alzprotect's team to envision the development of the PSP treatment in Europe and the United States as well as an acceleration of the development of treatments for other indications, in particular Alzheimer's disease, which could thus be the target indication of clinical trials by the end of 2023.
AZP2006 has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It was tested on 102 healthy human subjects throughout three phase I clinical trials and reported excellent tolerability, with no adverse effects.
Dr. Susanna Del Signore, Chief Medical Officer, commented: “This is a real success for Alzprotect to have completed in time a methodologically complex study which will allow for, once its bio-analytical and pharmacokinetic results are integrated with the excellent clinical safety data, confirmed by the Data and Safety Monitoring Board on several occasions, the proposal of a confirmatory study plan to the European Agency and the FDA early next year. This represents real hope for the PSP patient community.”
As Dr. Jean-Christophe Corvol, Professor of Neuropharmacology and Head of the Department of Neurology at the Pitié-Salpêtrière Hospital, reminds us: "PSP is a rare but disabling neurodegenerative disease for which no treatment is currently capable of slowing down the progression. He explains: "AZP2006 would reduce neuronal loss and preserve the function of neurons in the areas of the central nervous system affected by PSP. The completion of this phase 2a clinical trial with the support of the Alzprotect teams is very encouraging.”
"We are very pleased with these clinical results which are excellent indicators of patient tolerance and promising signals for our drug candidate. We strongly believe in the potential of AZP2006 as a potential treatment for neurodegenerative diseases", said Dr Philippe Verwaerde, CEO of Alzprotect. He concludes: "Now, the next structuring steps are the publication of our phase 2a study, the preparation of the pivotal phase II/III in both Europe and the United States, and a fundraising process to pursue our projects and support people suffering from neurodegenerative diseases in therapeutic impasse," .