Asceneuron appoints Dr. Thomas C. Wessel as Chief Medical Officer

Asceneuron appoints Dr. Thomas C. Wessel as Chief Medical Officer

  • Appoints CNS specialist and establishes US presence with new office in Cambridge, MA

Lausanne, SWITZERLAND and Cambridge, MA, USA, December 6, 2018 – Asceneuron, an emerging leader in the development of innovative small molecules for the treatment of neurodegenerative diseases, announced today the appointment of Thomas C. Wessel, MD, PhD, as Chief Medical Officer. Tom has over 20 years of experience in the biopharmaceutical industry and will be responsible for progressing the development of Asceneuron’s lead program ASN120290 and a pipeline of novel small molecules through the clinic. Tom will be based at Asceneuron’s new offices in Cambridge, Massachusetts, where he will lead all regulatory and clinical development activities as part of the company’s further expansion in the United States.

Tom joins Asceneuron from Boston-based Flex Pharma, Inc. (NASDAQ: FLKS), where he was Chief Medical Officer. Tom is a board-certified neurologist with extensive drug development experience, including being the medical lead for three CNS products approved in the United States: Razadyne®, Lunesta® and Ampyra®. Prior to Flex Pharma, Tom was the Chief Medical Officer at Acorda Therapeutics, Senior Vice President of Clinical Research at Sepracor, and worked on several CNS projects at Janssen Pharmaceutica in Europe and the United States. Tom received his MD from the Ludwig-Maximilians-University in Munich and his PhD in experimental neurobiology at the Max-Planck-Institute for Psychiatry in Martinsried, Germany. He completed his residency in neurology at New York Hospital and Memorial Sloan-Kettering Cancer Center (Cornell University Medical Center) where he remained on the faculty for several years as an Instructor and Assistant Professor before joining the industry. 

Dirk Beher, Chief Executive Officer and Founder of Asceneuron, commented:
“Our tau approach has the potential to revolutionize the treatment of neurodegenerative diseases and we are very happy to add Tom with his high caliber experience to our team. His expertise and outstanding track record in CNS drug development will help Asceneuron progress its orally-bioavailable tau modifiers through clinical development in Europe, Canada and the United States. We very much look forward to working with Tom to address the high unmet medical need in tau-related dementias and related diseases.” 

Tom Wessel, newly appointed Chief Medical Officer of Asceneuron, added:
“Asceneuron is a leader in the development of therapies focusing on the tau protein and is at a very promising stage of growth. The team at Asceneuron has recently generated very compelling data which promise to lead to novel treatments for CNS diseases involving tau pathologies including progressive supranuclear palsy, frontotemporal dementias, and Alzheimer’s disease. I am delighted to be working with a highly experienced team and a strong board at Asceneuron as we bring our first-in-class small-molecule therapeutics to patients.” 

Asceneuron announced last month it had commenced a new clinical trial of its lead program, ASN120290. The study aims to quantify target engagement of ASN120290 in the human brain using positron emission tomography (PET) to help guide dose selection for a planned clinical efficacy trial in progressive supranuclear palsy (PSP), a rapidly progressing rare neurodegenerative disorder. ASN120290 has the potential to become a first-in-class treatment for PSP, and other tau-related dementias.

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Asceneuron initiates neuroimaging trial for tau modifier ASN120290

Asceneuron initiates neuroimaging trial for tau modifier ASN120290

  • Major milestone in development of novel treatment for progressive supranuclear palsy and other tau-related dementias

Asceneuron SA, an emerging leader in the development of innovative small molecules for the treatment of neurodegenerative diseases, announced today it has commenced a new clinical trial of its lead asset, ASN120290. The study aims to quantify target engagement of ASN120290 in the human brain using positron emission tomography (PET) to help guide dose selection for a planned clinical efficacy trial in PSP.  ASN120290 has the potential to become a first-in-class treatment for progressive supranuclear palsy (PSP), a rapidly progressing rare neurodegenerative disorder, and other tau-related dementias.

ASN120290 is a selective inhibitor of the O-GlcNAcase enzyme and was recently granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of PSP. Its therapeutic potential has been demonstrated in preclinical studies with a profound reduction in the accumulation of toxic aggregates of the tau protein into neurofibrillary tangles. Neurofibrillary tangles are now widely recognized as the main cause of neurodegeneration and clinical symptoms in the majority of dementia cases, including Alzheimer’s disease (AD). 

Dirk Beher, Chief Executive Officer and Founder of Asceneuron, commented: The application of PET imaging to demonstrate that a drug molecule reaches its intended therapeutic target in the brains of living human beings has become best practice in CNS drug discovery. PET imaging provides tremendous value to accelerate clinical development programs. The PET imaging data will be critical for dose selection in subsequent studies with ASN120290. We are excited about this new clinical trial with ASN120290 which demonstrates our continuing commitment to bring urgently needed treatments to patients with PSP and other tau-related neurodegenerative diseases.” 

PET imaging is a non-invasive method to quantify the binding of ASN120290 to the O GlcNAcase enzyme in the living human brain. In this study, a specific enzyme inhibitor-derived imaging agent (PET tracer) will be administered either alone or after a pre-dose of ASN120290 in healthy volunteers. Once the PET tracer is introduced into the bloodstream, it crosses the blood-brain barrier and binds directly to the O-GlcNAcase enzyme inside brain cells. When ASN120290 is given prior to the tracer, it binds to the same enzyme in the brain thereby blocking the binding of the subsequently administered PET tracer. This decrease of PET tracer binding can be quantified, thereby allowing to calculate O-GlcNAcase enzyme occupancy by ASN120290.

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Asceneuron’s tau modifier ASN120290 receives Orphan Drug Designation for progressive supranuclear palsy from the FDA

Asceneuron’s tau modifier ASN120290 receives Orphan Drug Designation for progressive supranuclear palsy from the FDA

  • Advancement of novel inhibitor targeting accumulation of toxic neurofibrillary tau tangles

Asceneuron SA, an emerging leader in the development of innovative small molecules for the treatment of neurodegenerative diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to ASN120290 for the treatment of progressive supranuclear palsy (PSP), a rapidly progressing rare neurodegenerative disorder. ASN120290 was discovered at Asceneuron and is a selective inhibitor of the O-GlcNAcase enzyme. Based on its unique mechanism of action, the molecule has the potential to become a first in class treatment for PSP and other tau-related dementias.

ASN120290 has recently completed a randomized, double-blind, placebo-controlled phase I study to assess its safety and tolerability of single and multiple doses in healthy young and elderly volunteers. Data from that study will be presented at the upcoming Alzheimer’s Association International Conference (AAIC) to be held in Chicago July 22-26, 2018.

The therapeutic potential of ASN120290 has been demonstrated in preclinical studies with a substantial reduction in the build-up of toxic aggregates of tau into neurofibrillary tangles. Neurofibrillary tangles are widely recognized as a key driver of neurodegeneration and clinical symptoms in the majority of dementia cases, including Alzheimer’s disease.

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. 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 and a founder of Asceneuron, commented: “PSP is a rare neurological condition for which there is currently no treatment available. ASN120290 is an orally bioavailable molecule that has the potential of treating the root cause of the neurodegeneration. The granting of Orphan Drug Designation for ASN120290 by the FDA is an important milestone for the team and the company. It strengthens our commitment to serving this important unmet medical need and bringing this molecule to patients.”

Orphan Drug status is intended to advance drug development for rare diseases. The FDA provides Orphan Drug Designation to drugs and biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design and an exemption from FDA user fees.

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Asceneuron Receives Regulatory Approval for Phase I Healthy Volunteer Study of Oral Tau Inhibitor

Asceneuron Receives Regulatory Approval for Phase I Healthy Volunteer Study of Oral Tau Inhibitor

  • First-in-human trial of novel inhibitor targeting accumulation of toxic neurofibrillary tau tangles to fight neurodegenerative diseases including dementia

Asceneuron SA, an emerging leader in the development of innovative small molecules for neurodegenerative diseases, announced today the regulatory approval of its clinical trial application to initiate a first clinical study of ASN120290 (formerly known as ASN-561), belonging to a chemically novel group of O-GlcNAcase enzyme inhibitors. Based on preclinical studies, ASN120290 has the potential to become a new treatment for dementia.

The objective of the randomized, double-blind, placebo-controlled, phase I study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple doses of orally administered ASN120290. Within this phase 1 study, Asceneuron will assess a blood-based biomarker to support optimal dose selection of ASN120290 for future trials. Upon successful completion of phase 1, a phase 2 proof-of-concept trial in the orphan tauopathy disease progressive supranuclear palsy (PSP) is planned for 2018 in elderly patients. PSP is a rare neurological condition that causes serious problems with walking, balance, speech, swallowing and vision as a result of the accumulation of aggregates of the tau protein in the brain. Three to six people per 100,000 will develop PSP and there is currently no cure. 

The therapeutic potential of ASN120290 has been demonstrated in preclinical studies in which it has been shown to substantially reduce the build-up of toxic aggregates of the tau protein into neurofibrillary tangles. Neurofibrillary tangles are widely recognized as a key driver of neurodegeneration and clinical symptoms in the majority of dementia cases, including Alzheimer’s disease. 

Dirk Beher, chief executive officer and a co-founder of Asceneuron, commented: “This is a significant milestone for Asceneuron and marks our transition to a clinical stage company. It is also a major achievement for our scientific team as ASN120290 is our first in-house developed molecule reaching the clinic and was designed to easily enter the brain. New approaches to treat dementia are urgently required and preventing toxic tau tangle formation with our O-GlcNAcase inhibitor represents a new mechanism of action.” 

J. Michael Ryan, chief medical officer of Asceneuron, added: “Neurodegenerative diseases are a growing public health concern, with high unmet medical need and no approved treatments for slowing disease progression. Receiving regulatory approval to progress ASN120290 into phase 1 moves us closer to our goal of bringing innovative, orally-administered, tau-focused therapies to patients suffering from neurodegenerative diseases.”

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Asceneuron today announced the appointment of J. Michael Ryan, M.D. as Chief Medical Officer.

Asceneuron today announced the appointment of J. Michael Ryan, M.D. as Chief Medical Officer.

  • With over 15 years of Central Nervous System (CNS) clinical research experience, Michael brings extensive drug development expertise to Asceneuron.
  • He will be responsible for advancing Asceneuron’s pipeline of innovative small molecules and progressing tau modifiers through the clinic.

Asceneuron SA, an emerging leader in the development of innovative small molecules for neurodegenerative diseases, today announced the appointment of J. Michael Ryan, M.D. as Chief Medical Officer. With over 15 years of Central Nervous System (CNS) clinical research experience, Michael brings extensive drug development expertise to Asceneuron. He will be responsible for advancing Asceneuron’s pipeline of innovative small molecules and progressing tau modifiers through the clinic.  

Michael joins Asceneuron from Novartis Pharmaceuticals Corporation, where he was Vice President in the Neuroscience Development Franchise and Therapeutic Area Head for Neurodegeneration for five years. At Novartis, he worked on the clinical development strategy and led programmes in a number of CNS indications including Alzheimer’s disease, Parkinson’s disease and Schizophrenia. He has also held a number of senior clinical research and development positions at several multi-national companies including Pfizer, Wyeth Research, and MSD Research Laboratories (known as Merck Research Laboratories in the United States).

Michael completed training in geriatric psychiatry and neuropsychiatry at Dartmouth Medical School and has published over 30 scientific articles on neurodegenerative diseases. He has held academic positions at Dartmouth Medical School and the University of Rochester, where he co-directed the Geriatric Neurology & Psychiatry Clinic until 2004. Michael holds an M.D. in Medicine from the Medical University of South Carolina and a B.S. in Biology from Georgetown University.

Dirk Beher, CEO of Asceneuron, commented: “We are delighted to welcome Michael to the Asceneuron team. His outstanding track record and expertise in neurodegenerative disease are crucial as we are about to progress our first highly brain penetrant and orally bioavailable tau modifier into the clinic for the treatment of a number of orphan CNS disorders. We look forward to working with Michael in addressing this high unmet medical need and developing our pipeline to bring our innovative small-molecule therapeutics to patients.”

Michael Ryan, newly appointed CMO of Asceneuron, added: “Asceneuron is at an exciting stage of development as it looks to take its tau modifiers into the clinic. I look forward to working with such a highly experienced board and dynamic team as we progress the pipeline and develop important treatment options for patients with neurodegenerative diseases.”

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Asceneuron today announced the appointment of Hans Schikan (PharmD) as Non-Executive Chairman to the Board of Directors.

Asceneuron today announced the appointment of Hans Schikan (PharmD) as Non-Executive Chairman to the Board of Directors.

Asceneuron SA, an emerging leader in the development of innovative small molecules targeting tauopathies such as progressive supranuclear palsy (PSP), Alzheimer’s disease and related neurodegenerative diseases, today announced the appointment of Hans Schikan (PharmD) as Non-Executive Chairman to the Board of Directors.

“We are extremely pleased to welcome Hans Schikan as Chairman to our Board of Directors in recognition of the rapid progress the company has made in the development of drug candidates for rare tauopathies which is supported by our recent CHF 30 million Series A financing round” said Dirk Beher (PhD), Chief Executive Officer and a Founder of Asceneuron. “Hans’ vast orphan drug development expertise will help us tremendously in moving this company toward our ultimate goal to bring new medicines to patients and their families.”

Hans Schikan is former Chief Executive Officer of Prosensa, a biopharmaceutical company focusing on novel RNA modulating treatments for rare diseases like Duchenne muscular dystrophy. Prosensa was listed on NASDAQ (RNA) since June 2013. The company was acquired by BioMarin early 2015 for up to USD 840 million. Before joining Prosensa, Hans worked at Genzyme, including as Vice President for Global Marketing and Strategic Development of Genzyme’s product portfolio for rare genetic diseases. Prior to Genzyme, he worked at Organon, both at corporate level and in country operations which included assignments in Asia and Europe. Hans is currently Chairman of the Board of Complix (Belgium) and InteRNA Technologies (Netherlands). In addition, he is Board Member of Hansa Medical, Sobi and Wilson Therapeutics (Sweden). He is also Member of the Top Team of the Dutch Top Sector Life Sciences & Health and Adviser of Khondrion (Netherlands).

“I am delighted to join Asceneuron at this exciting time in the company’s development, with solid science, a promising pipeline, a great team and a strong syndicate of investors” said Hans Schikan. “I look forward to adding my experience and helping the team to develop its products in progressive supranuclear palsy (PSP), Alzheimer’s disease and related neurodegenerative diseases, which represent a huge medical need.”

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About Asceneuron

Asceneuron is a clinical stage biotech company focused on the development of orally bioavailable therapeutics for debilitating neurodegenerative disorders with high unmet medical need. The company’s pipeline reflects its ambition and commitment to developing treatments for a wide a range of neurodegenerative diseases including Alzheimer’s and Parkinson’s disease, as well as orphan tauopathies. Asceneuron has two clinical-stage small molecule O-GlcNAcase inhibitors in development for the treatment of proteinopathies: OGA inhibitor ASN90 (licensed to Ferrer Pharmaceuticals) for the treatment of progressive supranuclear palsy (PSP) and a potential best-in-class OGA inhibitor, ASN51 for Alzheimer’s disease. Asceneuron is backed by a renowned syndicate of investors consisting of Sofinnova Partners, M Ventures, SR One, Johnson & Johnson Innovation – JJDC, Inc. (JJDC) and Kurma Partners. For more information, please visit www.asceneuron.com.