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 is preparing for initiation of new clinical trials of AUD1001 for sensorineural hearing loss at multiple sites in Europe and in the US in H2 2021. The planned Phase 2b double blind, placebo controlled trials will be conducted in adults with demonstrated loss of clarity, using a standardized local drug delivery. The trials are designed to evaluate efficacy and to continu to monitor safety  of AUD1001 in people with hearing loss due to age, noise damage or of unknown cause (idiopathic), including people who have lived with hearing loss for up to 15 years.

Our vision is to bring a treatment to a large number of people and help them restore their hearing ability and quality of life