Development
Advanced Development
Audion’s lead program has undergone a thorough and extensive preclinical characterization in multiple model systems prior to initiation of the clinical studies. These studies include effects of the drug on damaged inner ear tissue, inner ear PK studies to determine drug exposure using different formulations and formal ototoxicity studies to exclude toxic effects on normal hair cells and inner ear tissues.
Our lead program has now completed clinical Phase 1 and Phase 2 testing, delivering encouraging results that support advancement into Phase 2b studies.
The clinical studies tested Audion’s drug in a total of 59 people with sensorineural hearing loss who were given 3 doses of the drug. A large portion of the patients was followed up for 12 months. The REGAIN study was designed and conducted in collaboration between Audion, University College London (UCL) in the UK, University of Athens in Greece and the University of Tubingen in Germany. For manufacturing and toxicology the program was supported by Chorus, a specialty unit of Eli Lilly specialized in early clinical development for internal and external assets.
AUD1001 was shown to be safe and well tolerated, and provided early indications of efficacy in speech in noise, a key clinical outcome parameter. Importantly, the efficacy signals persisted a year after the treatment.
Audion currently has no ongoing clinical studies and at this time has no studies scheduled to be started in the near future, pending raising additional funds for next studies through investment or partnering.
Our vision is to bring a treatment to a large number of people and help them restore their hearing ability and quality of life