Alzprotect Completes Phase 2a Clinical Trial Enrollment for AZP2006 in Progressive Supranuclear Palsy (PSP)
Lille (France), January 20th, 2022 – ALZPROTECT, a biopharmaceutical company developing treatments for neurodegenerative diseases, today announced it has completed patient enrollment for the Company’s phase 2a clinical trial evaluating its platform asset, AZP2006 (“EZEPROGIND”) in Progressive Supranuclear Palsy (PSP), a rare neurodegenerative disorder which seriously impacts walking, balance, eye movement, and in the latter stage of the disease, the ability to swallow. This PSP trial, which is part of a multi-indication development plan for AZP2006, has recruited thirty-six patients and is being conducted at the Pitié-Salpêtrière University Hospital of Paris, the University Hospital of Lille, and the Hospital Foundation Adolphe de Rothschild. For PSP, AZP2006 has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) and 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.
“This is an important milestone for the company and of course, the PSP patient community who are suffering from this debilitating disease where there are no treatment options currently available, “commented Philippe Verwaerde, CEO of Alzprotect. “All of us involved with the development of AZP2006 are excited by its potential to be used as standalone therapy in early disease, and for its being able to be combined easily with other agents as neurodegenerative diseases progress fast. At the time when novel neurology agents are coming under acute reimbursement scrutiny, a simple modality like AZP2006 makes good sense as an addition to the treatment armamentarium in neurodegenerative diseases. As such this Phase 2A in PSP will serve as an excellent proxy for patient tolerability and early efficacy signals for this drug candidate.”
Alzprotect is developing AZP2006 (EZEPROGIND), an orally available small molecule which has demonstrated that it can augment the functional half-life of Progranulin in the brain to help restore microglia homeostasis in neurodegenerative diseases. By modulating Progranulin through its cognate lysosome-trafficking chaperone protein, Prosaposin, AZP2006 works through a novel mechanism of action from other Progranulin-inducing agents in clinical development so far. Due to its nuanced control of Progranulin, AZP2006 can be used to treat a variety of neurodegenerative diseases and does not have to limited to one/few indications. Upon evaluation of the results from the Phase 2A PSP trial, the Company will launch a US IND for a randomized Phase 2B/3 trial in this indication. Also, as part of its multi-indication drug development plan additional trials in three new indications, GBA-1 Parkinson’s disease, Alzheimer’s disease and Amyotrophic lateral sclerosis will be launched by 2023.
About the Phase 2a study with EZEPROGIND in PSP
The primary objective of this clinical trial is to evaluate the tolerability of the product in PSP patients; to strengthen the pharmacokinetic (PK) and pharmacodynamic (PD) 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 is expected to be completed by July 2022 with top-line results published in Q3 2022. As part of the trial, 36 PSP patients receive a placebo or one of two EZEPROGIND doses which are administered orally for 3 months, followed by a 3-month observation period.
Efficacy endpoints include PK/PD evaluation of AZP2006 in patients, biomarker data across a panel of chosen biomarkers, and evaluating four-different PSP rating scales to be used in subsequent and registrational trials.
About Progressive Supranuclear Palsy (PSP)
PSP is a tauopathy with predominant accumulation of Tau isoforms with four repeat motifs (4R). It is characterized by neurofibrillary degeneration and neuronal loss in the brainstem, basal ganglia, frontal motor and associative cortex. The disease causes brainstem damage that progressively affects balance, vision, mobility, swallowing and speech. 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.
Alzprotect imagines and develops therapeutic solutions to slow down or stop neurodegenerative diseases and restore patients’ brain capacity. Founded in 2007, Alzprotect is a French Lille-based company created by Dr. André Delacourte, one of the pioneers of research on Alzheimer's disease, and Dr. Patricia Melnyk, expert in medicinal chemistry, in collaboration with Lille 2 University and INSERM. The company employs 8 people and is supported by BPI France, the National Research Agency and Eurasanté. Alzprotect is committed to the development of innovative therapeutic solutions in the field of neurodegenerative diseases. Alzprotect has 4 international patent families covering the medicines it develops and their indications worldwide.
For more information: http://www.alzprotect.com/en – page LinkedIn – corporate video - Ezeprogind MOA video
Lille (France), June 22nd, 2021 - ALZPROTECT, a biopharmaceutical company engaged in the development of drugs for the treatment of Alzheimer's disease, announced today that Dr. John Tchelingerian has joined the Board of Directors of Alzprotect. Alzprotect is financed by the Xerys Funds.
Dr John Tchelingerian is a serial entrepreneur in life sciences. As a veteran of the industry, he co-founded and/or lead several biotech companies as CEO or Chairman & CEO. He raised a total of over €200 million of funding during his career and achieved together with his teams to bring five drug candidates from research to the clinics (up to phase IIb/III) and realized several international pharmaceuticals partnering and M&A deals. He is currently the Managing Partner and co-founder of two specialized strategic advisory firms, The Connecting Architects and Silver Ocean Ventures and Chairman of Pan-Cancer T’s Supervisory Board. He is a PhD graduate in Neurosciences from Pierre et Marie Curie University in Paris.
Dr. John Tchelingerian commented: « I am delighted joining the board of Alzprotect as a Director to contribute to the company’s growth and its success. The company has made remarkable progress since the first time I met Philippe and his team a few years ago. I am convinced that Alzprotect will be a game changer in the field of PSP with its drug-candidate AZP-2006, currently in phase 2a clinical trials in Europe. »
Dr Philippe Verwaerde, President of Alzprotect, declared: "John's profile and experience are valuable assets to strengthen our board of directors on the eve of a strategic inflection point and a rise in development of Ezeprogind / AZP2006 "
Alzprotect and the Rothschild Foundation Hospital announce the signing of a collaboration in a phase 2 clinical trial for the treatment of Progressive Supranuclear Palsy
Lille (France), May 11th - Alzprotect, biopharmaceutical company developing therapeutic solutions for neurodegenerative diseases, and the Adolphe de Rothschild Foundation Hospital announced today the signing of a collaboration agreement. This first materializes with the opening in Paris, within the Rothschild Foundation Hospital of the 3rd clinical center, as part of the phase 2a trial aimed at evaluating the safety of the main drug candidate of the company, EZEPROGIND (AZP2006) for the treatment of progressive supranuclear palsy (PSP). PSP is an orphan disease for which Alzprotect has obtained "orphan drug" status from the Food and Drug Administration (FDA) and the European Medicines Agency. Alzprotect is financed by the Xerys funds.
With EZEPROGIND, Alzprotect mainly targets two neurodegenerative diseases: Progressive Supranuclear Palsy (PSP) for which there is no treatment to date and Alzheimer's disease, recognized as a major public health issue, currently without any reliable early diagnosis or treatment that can modify the course of the disease.
Dr Pierre Le Sourd, member of the Supervisory Board of Xerys Gestion and member of the Board of Directors of Alzprotect, declares “It is our duty at Xerys to invest in companies whose mission is to identify solutions for diseases that are public health priorities. We are proud of this scientific partnership with the Adolphe de Rothschild Foundation Hospital. This is a very strong signal. I would like to thank Mr. Julien Gottsmann as well as all the teams who make it possible to accelerate this project to fight neurodegenerative diseases. "
Monsieur Julien Gottsmann, CEO of the Rothschild Foundation Hospital emphasizes: "The signing of this agreement with the biotechnology company Alzprotect will allow us to jointly conduct a clinical trial to evaluate a treatment against Progressive Supranuclear Palsy. This partnership signed within the framework of Rothschild Medical Development brings hope for treatments to patients suffering from PSP. "
Dr Michael Alexandre Obadia, neurologist at the Rothschild Foundation Hospital adds: "Supra-nuclear paralysis is a severe pathology with a poor prognosis; the development of new therapies is a major issue in this field. I look forward to participating in this ambitious project on behalf of the Hospital and the collaboration that is beginning with the Alzprotect teams. "
Dr Philippe Verwaerde, President of Alzprotect, said: “We are very excited to start this collaboration and to benefit from the internationally recognized expertise of the Rothschild Foundation Hospital and its teams in the field of neurology. The hospital is also monitoring a large number of PSP patients, which will allow us to complete our phase 2a study, and hopefully continue to develop our scientific collaboration. "
Lille (France), April 8th, 2021 – Alzprotect, a biopharmaceutical company developing therapeutic solutions for neurodegenerative diseases announces today today hat it has established its US based subsidiary, Alzprotect US Inc. in Boston, Massachusetts, in line with its international development strategy.
This new subsidiary of Alzprotect is situated in Boston. The world’s ten largest biopharma companies have a presence in Massachusetts, making it an ideal location for scientific and technological innovation and ideally suited for Alzprotect’ first US foothold.
The creation of this affiliate is the first milestone in a process that will lead to the initiation of Alzprotect’ clinical trials for the treatment of PSP and Alzheimer’s disease in the US.
Dr Philippe Verwaerde, CEO of Alzprotect, commented: “The creation of a subsidiary in the US is an important step forward in our strategy as set out in our future development. This further strengthens the international reach of our innovative pipeline for the treatment of neurodegeneration. We are very excited to become part of the biotechnology cluster in Cambridge and believe this prime location will prove to be extremely beneficial to the Company as we move our clinical development forward in this important market.”
Lille (France), March 7th, 2021 – Alzprotect, a biopharmaceutical company developing therapeutic solutions for neurodegenerative diseases is pleased to announce the company will present virtually at the 14th Annual European Life Sciences CEO Forum that will take place from the 10th to the 12th of March 2021, aspart of the Digital Sachs Spring Life Sciences Week.
Philippe Verwaerde, Chief Executive Officer of Alzprotect will provide an overview of the development program of the company’s drug Ezeprogind® and will be available for questions and one-on-one meetings with attendees registered for the conference.
Dr Verwaerde will also participate in a “Progress in Alzheimer’s Dementia and Diagnostic” panel on March 11th at 5 PM.
“There is currently no available treatment to slow down or stop diseases related to neurodegeneration which affect tens of millions of people worldwide. Participating in this event allows us to share our unique innovation and progress involving the regulation of complex intracellular processes including inflammatory pathways and neuronal survival. Along with our experts, partners, and investors, we are proud of our recent progress and look forward to the next steps” Dr. Verwaerde said.
The 14th Annual ELSF is will include the BioCapital & Investment Day and the Bio-Pharma Partnering & Therapeutics Day on 10th and 11th of March. These two days will feature more than 14 hours of high-level speeches, panel discussions and spotlight showcases by more than 400 leading industry corporates.
Alzprotect strengthens its Intellectual Property Portfolio for its First-in-Class Clinical Stage Drug Ezeprogind
Lille (France), November 23rd, 2020 – Alzprotect, a biopharmaceutical company developing therapeutic solutions for neurodegenerative diseases announces today that the United States Patent and Trademark Office (USPTO) has recently granted patent number US 10,772,884 concerning the therapeutic uses of its first-in-class clinical stage drug Ezeprogind (AZP2006) in the treatment of tauopathies. This patent completes the Ezeprogind related patents granted in the USA for composition of matter (US 9,562,018) and therapeutic uses in the treatment of Alzheimer’s and Parkinson’s diseases (US 10,537,569).
This strengthens Alzprotect portfolio of patents covering Ezeprogind that were already granted in Europe (EP 2 938 597 - validated in 26 member states of the European Patent Convention), and in 11 other countries including Japan (JP 6384923) and China (CN 105008333).
All these patents will be in force until at least 27th December 2033, subject to patent term adjustment or extension, and similar applications are currently under examination in Canada and Brazil.
Alzprotect co-owns or has an exclusive worldwide license from the French National Institute of Health and Medical research (Inserm) and the University of Lille (France) on a total of 58 patents related to Ezeprogind in 39 countries.
Alzprotect continues to expand the Ezeprogind intellectual property with the filing of two new European priority patent applications that will be extended to several other countries outside Europe directed to novel therapeutic uses for specific neurodegenerative diseases as well as new forms of the molecule intended for solid formulations of the drug.
Philippe Verwaerde, Chairman & Chief Executive Officer of Alzprotect, declared: “This new granted patent will reinforce our strong intellectual property portfolio which is a major asset for our company. I am also happy to extend it with two new applications in both therapeutic and formulation fields.”
Cyrille Brantis, Intellectual Property Manager of Alzprotect, declared: “The grant of Ezeprogind composition of matter and therapeutic use patents in several major countries worldwide provides a significant protection of Ezeprogind’s intellectual property and is a key milestone for Alzprotect. The new patent applications are the outcome of years of high-quality research engaged by Alzprotect and highlight the company’s commitment to the development Ezeprogind.”
Alzprotect is financed by the XERYS fund (Paris).