Asceneuron awarded USD 2.2 million to advance into phase 1 clinical trials

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12.03.2021

The Alzheimer’s Drug Discovery Foundation has awarded Asceneuron USD 2.2 million to conduct a first in human Phase I study of its next-generation O-GlcNAcase inhibitor, ASN51 in healthy subjects and Alzheimer’s patients. 

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 pipeline reflects our ambition to develop treatments for as wide a range of neurodegenerative diseases including orphan tauopathies, Alzheimer’s and Parkinson’s diseases. The lead program ASN120290, an O-GlcNAcase inhibitor, is being developed for the orphan tauopathy progressive supranuclear palsy (PSP). 

The Company is also developing a next-generation O-GlcNAcase inhibitor ASN51 to target Alzheimer’s disease and related disorders. O-GlcNAcase is an emerging drug target in the central nervous system (CNS) drug development since deficient glycosylation patterns of intracellular proteins have been associated with diseases of ageing and neuronal dysfunction. O GlcNAcase inhibitors prevent the elimination of intracellular protein glycosylation, thereby halting the decline of the steady-state levels of this posttranslational modification. O GlcNAcase inhibitors have initially been pursued exclusively for tau-related diseases. Emerging 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. 

Following the receipt of a 2.2 million award from the Alzheimer’s Drug Discovery Foundation (ADDF), Asceneuron will advance to phase 1 clinical trials. The fund will enable a Phase 1 single ascending dose arm and a positron emission tomography (PET) target engagement study in healthy volunteers. Phase 1 clinical trials will assess the safety and tolerability of ASN51, and closely examine multiple biomarkers relevant to the target mechanism and neurodegeneration in healthy subjects and Alzheimer’s patients. The study will be conducted at sites in Europe and Australia towards the end of this year. The study will kick off in Q2 with the first interim data due in Q3 2021.

Dirk Beher, Chief Executive Officer and a Co-Founder of Asceneuron commented: “This Phase I clinical study targeting the root cause of neurodegeneration comes at a time when our current knowledge of the biology of O GlcNAcase has reached a critical inflection point. As a leader in this field, and with the welcome support of ADDF, we plan to translate our novel and exciting biology into significant health benefits for patients with neurodegenerative diseases.”

About the ADDF
The Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, the ADDF has awarded more than $168 million to fund over 650 Alzheimer's drug discovery and biomarker programs and clinical trials in 19 countries. 

(Press release/RAN)

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