Lausanne, SWITZERLAND and San Francisco, CA, USA, 1 April 2022 – Asceneuron SA, a clinical stage company dedicated to targeting the root causes of neurodegenerative diseases, today announces the publication of peer-reviewed data in the journal ACS Chemical Neuroscience regarding ASN90, an O GlcNAcase (OGA) inhibitor, and one of its leading candidates in clinical development for treating neurodegenerative proteinopathies.

Neurodegenerative proteinopathies such as Alzheimer’s and Parkinson’s disease are characterized by the intracellular formation in the brain of insoluble and toxic protein aggregates, such as the microtubule-associated protein tau and α-synuclein respectively, that are closely linked to disease progression. OGA is an emerging drug target in central nervous system drug development since deficient glycosylation of these intracellular proteins has been associated with neuronal dysfunction. OGA inhibitors prevent the elimination of intracellular protein glycosylation, thereby halting the decline of the healthy-state levels of this post-translational modification and preventing the formation of toxic protein aggregates.

In this recently published, peer-reviewed paper, Asceneuron reports the preclinical discovery and development of the novel small molecule OGA inhibitor ASN90 (formerly known as ASN120290/ASN561), which has already completed testing in three Phase I studies in healthy young and elderly subjects. The preclinical data show that daily oral administration of ASN90 prevented the development of tau tangle pathology, as well as functional deficits in motor behavior and breathing, and increased survival. Another significant finding; novel for this class of molecules; is that ASN90 slowed the progression of motor impairment and reduced astrogliosis in a frequently utilized, preclinical model of Parkinson’s disease.

Asceneuron currently has an open investigational new drug (IND) application with the US Food and Drug Association (FDA) for a Phase 2/3 study to evaluate ASN90 in progressive supranuclear palsy (PSP), an orphan indication. PSP is a rare neurological condition that causes severe problems with walking, balance, speech, swallowing and vision as a result of the accumulation of aggregates of the tau protein in the brain. The disease gets progressively worse, with people becoming severely disabled within three to five years of onset. It is estimated that three to six people per 100,000 will develop PSP and there is currently no cure for the disease.

Dirk Beher, Chief Executive Officer, Co-Founder of Asceneuron and senior author of the study, commented: 

“We are very excited to publish such key encouraging preclinical data on ASN90 and OGA mechanism of action. These findings provide a strong rationale for the development of OGA inhibitors as disease-modifying agents in both tauopathies and α-synucleinopathies such as Alzheimer’s, PSP, and Parkinson’s disease. Since tau and α-synuclein pathologies frequently co-exist in neurodegenerative diseases, OGA inhibitors represent unique, multimodal drug candidates for multiple indications. We continue to progress our clinical development with our latest once a day OGA inhibitor, ASN51, which will be dosed in Alzheimer’s disease patients in the forthcoming months.”

The article has been published online ahead of print and can be found here: O-GlcNAcase Inhibitor ASN90 is a Multimodal Drug Candidate for Tau and α-Synuclein Proteinopathies.

Lausanne, SWITZERLAND and San Francisco, CA, USA, 30 September 2021 – Asceneuron SA, a clinical stage company dedicated to targeting the root causes of neurodegenerative diseases such as the intracellular aggregation of the microtubule-associated protein tau, is pleased to announce that the Company will be presenting novel data on its O-GlcNAcase (OGA) inhibitor pipeline at the following upcoming conferences.

22nd International Conference on Alzheimer’s Drug Discovery
Date: 4-5 October 2021, New York. Virtual Conference.
Session: Clinical trials and novel approaches for Dementia
Presentation: OGA inhibitors as multimodal drugs for intracellular proteinopathies on Monday, 4 October, 16:45 CET/10:45 US ET.

146th Annual Meeting of the American Neurological Association
Date: 17-19 October 2021, New Jersey.  Virtual Conference.
Presentation: Efficacy of ASN51, an Orally Bioavailable Small-Molecule O-GlcNAcase Inhibitor, in Models of Parkinson’s Disease and Epilepsy, on Monday, 18 October, 23:30 CET/ 18:30 US ET.

EUROTAU
Date: 25-26 October, 2021. Lille, France.
Presentation: OGA inhibitors as multimodal drug candidates for tau- and alpha-synucleinopathies on Tuesday, 26 October, 14:55 CET.

Dirk Beher, Chief Executive Officer and Co-Founder of Asceneuron, stated: 

“We are delighted to have been invited to present at three leading conferences to discuss and share the latest insights on our proprietary pipeline of O-GlcNAcase inhibitors. The data generated so far are an important development in addressing the challenges seen in Alzheimer’s and Parkinson’s diseases drug development and demonstrate our continuing commitment to bring urgently needed treatments to patients with tau-related neurodegenerative diseases.”

O-GlcNAcase is an emerging drug target in central nervous system (CNS) drug development since deficient glycosylation patterns of intracellular proteins have been associated with diseases of aging and neuronal dysfunction. O GlcNAcase inhibitors prevent the elimination of intracellular protein glycosylation, thereby halting the decline of the steady-state levels of this post-translational modification. O-GlcNAcase inhibitors have initially been pursued exclusively for tau-related diseases. Preclinical data suggest a wider application to intracellular proteinopathies such as Alzheimer’s disease and related disorders, and diseases of disturbed neuronal network function in general, with the potential to provide both disease-modifying and symptomatic benefits at the same time as multimodal drugs.

• Presenting at The Peter Davies Memorial Symposium: The Future of Tau Based Therapies

Lausanne, SWITZERLAND and San Francisco, CA, USA, 28 July 2021 – Asceneuron SA, a clinical-stage biotech company dedicated to targeting the root cause of neurodegenerative diseases, is pleased to announce that Chief Executive Officer, Dirk Beher has been invited to present at The Peter Davies Memorial Symposium: The Future of Tau Based Therapies during the prestigious Alzheimer’s Association International Conference which takes place between the 26 – 30 July 2021 in Denver, USA and online. The talk will take place on Wednesday, 28 July at 08:00am MDT / 4:00pm CET.

Dr Dirk Beher will discuss the topic “O-GlcNAcase Inhibitors as Therapies for Tauopathies” and will provide an update on the current status of Asceneuron’s O-GlcNAcase inhibitor research and clinical pipeline.

Dirk Beher, Chief Executive Officer and Co-Founder of Asceneuron, commented:

“I am honoured to have been invited to present at the Peter Davies Memorial Symposium during the Alzheimer’s Association International Conference and I am looking forward to discussing and sharing the latest insights on O-GlcNAcase biology and its role in tau-related and other diseases of intracellular protein aggregation.”

The Alzheimer’s Association International Conference is the largest and most influential international meeting dedicated to advancing dementia science. Each year, AAIC convenes the world’s leading basic science and clinical researchers, next-generation investigators, clinicians, and the care research community to share research discoveries that will lead to methods of prevention and treatment and improvements in the diagnosis of Alzheimer’s disease.

• Underscores company’s ambition to deliver on the unmet needs of patients living with neurodegenerative diseases

Lausanne, SWITZERLAND and San Francisco, CA, USA, 16 July 2021 – Asceneuron SA, a clinical stage company dedicated to targeting the root cause of neurodegenerative diseases, announced today the appointment of Catherine Moukheibir to its Board of Directors.

Catherine is a highly respected healthcare executive with extensive experience over the last 30 years of leadership in finance, capital markets and life sciences. She has previously worked as a Chairman, Non-Executive Director and Chief Executive Officer in the biotech and pharmaceutical sectors, successfully raising private and public capital as well as overseeing several major licensing deals and acquisitions. 

Catherine currently serves on the Board of Directors at Biotalys, CMR Surgical, Ironwood Pharmaceuticals Inc and Orphazyme A/S. Most recently, Catherine was the chair and CEO of MedDay Pharmaceuticals. She has held various other senior executive roles (Innate Pharma) and board memberships in companies such as Kymab, Ablynx, Genkyotex, Zealand Pharma and Creabilis. Earlier, she was the CFO of Movetis, overseeing the company’s IPO on Euronext and subsequent sale to Shire. Catherine started her career in investment banking and capital markets and worked in this industry for several years in the US and London, switching to corporate roles in life sciences 20 years ago. She holds an MBA and a Masters in Economics from Yale University. 

Peter Van Vlasselaer, Chairman of the Board of Asceneuron, commented: 

“We are delighted to welcome Catherine, a seasoned and highly respected industry leader, to the Board of Directors. Her corporate expertise and financial track record underscores our ambition and focus to deliver on the unmet needs of patients living with neurodegenerative diseases.” 

Catherine Moukheibir, Board of Directors of Asceneuron, commented: “Asceneuron is pioneering a new way of approaching neurodegenerative diseases and is developing a clinical pipeline of novel compounds which have the potential to be the basis for highly innovative treatments for a broad range of CNS diseases. I am pleased to be joining such an ambitious player in a field that has so much to offer to patients.” 

Dirk Beher, Chief Executive Officer and Co-Founder of Asceneuron, commented: “We are very pleased to have Catherine join Asceneuron at this particular stage of the company, given her extensive experience within the biotech industry. I look forward to shaping the growth of Asceneuron with Catherine’s valued insights and guidance as our two lead programs progress through clinical development.”

• Seasoned pharma & biotech executive joins the Board of mid-stage clinical company 

Lausanne, SWITZERLAND and Cambridge, MA, USA, May 20, 2019 – Asceneuron, an emerging leader in the development of orally bioavailable modulators of tau for the treatment of neurodegenerative diseases, today announces the appointment of Dr Eric Yuen to its Board of Directors.  

Dr Eric Yuen, has over 25 years of clinical development experience in central nervous system (CNS) pathologies and has led multiple Phase I-IV development programs for biologics and small molecules obtaining numerous regulatory approvals. He is currently Chief Medical Officer at Talee Bio Inc which he co-founded in addition to RiboNova Inc. Dr Yuen’s industry experience began at Merck Sharp & Dohme (known as Merck & Co in the United States) as Director of Clinical Research, where he focused on CNS and pain indications. He then spent nine years at Johnson & Johnson finally as Vice President of Clinical Development responsible for the portfolio of monoclonal antibodies and vaccines targeting Alzheimer’s disease. He has since held senior positions in several biotech companies including as Chief Medical Officer at Inozyme Pharma and Ultragenyx Pharmaceuticals. Before joining the industry, Dr Yuen was an assistant professor of neurology at the University of Washington, where he conducted clinical research in rare CNS disorders. Dr Yuen received his M.D. from the Pritzker School of Medicine at the University of Chicago and completed his neurology training at the University of California at San Francisco. He holds a B.S. in Physics and Biology with Academic Distinction from Stanford University. 

Peter Van Vlasselaer, Chairman of the Board of Asceneuron, said: 
“I would like to welcome Eric to the Board of Directors. His outstanding track record and expertise in CNS drug development will be invaluable as Asceneuron initiates later stage clinical development in the tau pathology space.” 

Dirk Beher, Chief Executive Officer and Founder of Asceneuron, added:
“Asceneuron is making rapid progress in the clinical development of orally-bioavailable tau modifiers and we are delighted to welcome such a highly experienced CNS clinician to the Board of Directors. Eric’s know-how will add tremendous value to Asceneuron’s development and our ultimate goal of bringing urgently needed medicines to patients.” 

Eric Yuen, Non-Executive Director of Asceneuron, commented:
“Asceneuron’s exciting compounds could be the basis for highly novel treatments of broad range of CNS diseases including progressive supranuclear palsy, frontotemporal dementia, and Alzheimer’s disease. I look forward to supporting the Asceneuron team in bringing its highly promising orally-bioavailable tau modifiers to underserved patient populations.” 

Asceneuron’s lead program ASN120290 is a small molecule inhibitor of the enzyme O-GlcNAcase. Based on its unique mechanism of action, ASN120290 has the potential to become a first in class treatment for progressive supranuclear palsy (PSP) and other tau-related dementias. 

Late last year the company appointed CNS specialist Dr Thomas C. Wessel as Chief Medical Officer in its US based team. Asceneuron recently completed a clinical trial with ASN120290 to quantify target engagement in the human brain using positron emission tomography (PET) the results of which will guide dose selection for a trial in PSP planned for later this year.

Asceneuron’s CEO Dirk Beher will be presenting at the BioEquity Europe Conference in Barcelona on Monday, May 20 at 2:00pm CET in Room Vivaldi 2, Crowne Plaza Barcelona Fira Center.

• Serial biotech entrepreneur joins leading small molecule tau modulation company

Lausanne, SWITZERLAND and Cambridge, MA, USA, January 17, 2019 – Asceneuron, an emerging leader in the development of orally bioavailable modulators of tau pathology for the treatment of neurodegenerative diseases, today announces the appointment of Peter Van Vlasselaer as Chair of the Board of Directors.

Peter Van Vlasselaer, PhD has over 20 years executive and entrepreneurial experience in the biotech industry. He was most recently the Founder, President and Chief Executive Officer of ARMO Biosciences, Inc. which shortly after its public offering (Nasdaq: ARMO) was acquired by Eli Lilly. Prior to this, he was President and Chief Executive Officer of iPierian (acquired by BMS), ARRESTO (acquired by Gilead) and AVIDIA (acquired by AMGEN). In addition to founding ARMO, Dr. Van Vlasselaer was the founder of ARRESTO, co-founder of TrueNorth (acquired by Bioverativ) and was a member of the start-up teams of InterMune (ITMN) and Dendreon (DNDN). He currently serves on the boards of BLADE Therapeutics, Comet Therapeutics and RGENIX. Dr. Van Vlasselaer has a degree in Zoology and a PhD in Immunology from the Catholic University of Leuven, Belgium. He was a Post-Doctoral Fellow in the Division of Immunology and Rheumatology at Stanford University Medical School and DNAX Research Institute. Dr. Van Vlasselaer has authored several peer reviewed scientific publications and book chapters and he is an inventor on multiple patents. 

Dirk Beher, Chief Executive Officer and Founder of Asceneuron, commented: “We are delighted to welcome Peter Van Vlasselaer to the Board. His extensive experience in all aspects of biotechnology, drug and corporate development will be invaluable as the Company progresses its orally-bioavailable tau modifiers through clinical development. With Peter’s addition to the board, our expanded US presence, and commitment to tau, Asceneuron is well positioned to revolutionize the treatment of neurodegenerative diseases.” 

Peter Van Vlasselaer, new Chairman of Asceneuron, added:
“There is a strong industry and scientific interest in tau approaches to Alzheimer’s disease and orphan tauopathies such as progressive supranuclear palsy (PSP). I believe Asceneuron’s technology represents a significant opportunity in the next generation of drugs that could potentially transform the treatment of PSP and other tau-related neurodegenerative diseases. These disorders have devastating outcomes for patients and their families. I look forward to maximising the potential of these innovative new treatments and support the Company through this important phase of growth.” 

Asceneuron’s lead program ASN120290 is a small molecule inhibitor of the enzyme O-GlcNAcase. Based on its unique mechanism of action, ASN120290 has the potential to become a first in class treatment for progressive supranuclear palsy (PSP) and other tau-related dementias.
The company recently announced the appointment of CNS specialist Dr Thomas C. Wessel as Chief Medical Officer. A clinical trial is ongoing with ASN120290 to quantify target engagement in the human brain using positron emission tomography (PET) the results of which will guide dose selection for an efficacy trial in PSP planned for later this year.