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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.”
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," .
Lille, France – June 1st 2022 – Alzprotect, a French biopharmaceutical company involved in the development of new therapeutic solutions in the neurodegenerative diseases area, today announced it has been awarded a USD $338,000 grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop the first-in-class brain penetrant small molecule targeting Progranulin (PGRN).
This grant will further expand Alzprotect’s research efforts to develop AZP2006 (INN Ezeprogind) into a new therapeutic area: Parkinson's disease (PD), with a focus on the GBA1 mutation-associated with Parkinson's disease (PD/GBA1). The grant will fund an early-stage program at Alzprotect to study the effects of AZP2006 in models of PD based on loss of function from preliminary results and a strong rationale. The objectives are to investigate the target engagement of AZP2006 and to perform a proof-of-concept (POC) study in an animal model of PD/GBA1.
Dr. Noelle Callizot, CSO declared: “We are pleased and very proud to have the scientific and financial support of the MJFF. The novel mode of action of AZP2006 involving the lysosome and progranulin allows us to consider the development of AZP2006 in PD/GBA1 patients. The excellent safety profile of AZP2006 makes it a promising candidate drug for these patients. We thank MJFF for its financial assistance in contributing to the achievement of our research goals.”
Dr. Philippe Verwaerde, President and CEO of Alzprotect, said, " We are very proud of the recognition of our preliminary research advances in Parkinson’s and of the potential of our lead compound AZP2006 based on progranulin modulation. This research progress is materialized today by this grant from the Foundation.”
France, Lille - 5th April 2022 - Alzprotect, a French biopharmaceutical company specialised in the development of new therapeutic solutions for the treatment of neurodegenerative diseases, in particular Alzheimer's disease, appoints Dr Susanna Del Signore as Chief Medical Officer (CMO).
Dr Susanna Del Signore has over 20 years of experience in research and development (R&D) in the pharmaceutical industry, particularly in the field of neurology. She has been a project leader, attaining the position of Chief Medical Officer (CMO), for the development of drugs across phases I to III. She has held increasing responsibility in large pharmaceutical (Servier and then Sanofi, between 1993 and 2015) and biotechnology companies (Biophytis between 2016 and 2018). From 2005 to 2009 she worked at the European Medicines Agency (EMA), in the evaluation of new pharmacological treatments for neurodegenerative diseases, liaising with European national agencies, the Food and Drug Administration (FDA), and clinical experts. Susanna Del Signore founded BLUECOMPANION in 2015, a start-up focused on the design and implementation of e-health projects for public-private partnerships and on innovative methodologies for the generation of regulatory quality clinical data. She has built meaningful expertise in the design and conduct of first-in-man and phase 2 clinical trials, clinical development planning, and regulatory strategy, both in France and internationally (Europe, USA, Japan). For instance, she contributed to a global regulatory policy project within the MIT-led think tank on adaptive licensing. In 2013, she coordinated on behalf of Sanofi and in collaboration with Eli Lilly, Novartis and GSK, an IMI (Innovative Medicines Initiatives) call for projects in geriatrics, targeting age-related sarcopenia as a new indication.
Dr Philippe Verwaerde, founder and CEO of Alzprotect, says: "I am delighted to welcome Susanna to our team; she has significant experience as a Chief Medical Officer and has a solid understanding not only of the issues related to the development of new generation therapies, but also of protocols and clinical trials as they evolve, arbitration, and reallocation of resources based on results and strategy. She has mastered, in all its ethical nuances, the imponderable need to discuss with the wider scientific community, KOLs, and patient associations according to the prerogatives set out by the regulatory authorities. We are confident that her experience combined with her managerial skills will be of great value to Alzprotect as we prepare to further develop AZP2006 in Phase 2/3 clinical trials for the treatment of progressive supranuclear palsy (PSP). Dr. Susanna Del Signore is a great asset to complement our team and and we are honored to have her support in the implementation of our clinical plan.”
"I am particularly proud be joining Alzprotect, a persevering French biotech company that is wholeheartedly and relentlessly dedicated to the development of ground-breaking therapies for neurodegenerative diseases, with products based on a novel and promising mechanism of action. I am thrilled to have been offered the opportunity to work on Progressive Supranuclear Palsy, an orphan neurodegenerative disease that primarily affects older persons, usually after the age of seventy . Such a disease should be diagnosed as early as possible and treated with a view to slowing motor and cognitive decline. I will be listening to and working with patients, their families, and the medical community to implement in our planned clinical trials the best methodologies," commented Dr Susanna Del Signore.
Olivier Ossipoff, Chairman of Xerys Invest, added: "We are very pleased to see Dr Susanna Del Signore appointed as Chief Medical Officer and join the Alzprotect team. Her arrival marks an important step in the evolution of this exceptional biotech company that we have been supporting since 2017 and underlines its desire to accelerate the implementation of its clinical development plan."
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.
About Alzprotect
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
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Contact:
ALZPROTECT
Dr Philippe Verwaerde, PhD
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 "
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.