Date: 2017-04-06
Type of
information: Clinical trial authorisation
phase: 1
Announcement: clinical trial authorization
Company: Asceneuron (Switzerland)
Product: ASN120290 (formerly known as ASN-561)
Action
mechanism: O-GlcNAcase enzyme inhibitor. ASN120290 is an O-GlcNAcase inhibitor that in preclinical studies has been demonstrated to modulate tau pathology.
Disease: dementia
Therapeutic
area: CNS diseases - Neurodegenerative diseases
Country:
Trial
details:
Latest
news:
- • On April 6, 2017, Asceneuron 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 is planned for 2018 in elderly patients.
- 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.
Is
general: Yes
