Date: 2015-04-27
Type of information: Recruitment of the first patient
phase: 2a
Announcement: recruitment of the first patient
Company: Autifony Therapeutics (UK)
Product: AUT00063
Action
mechanism: AUT00063 is an orally active small molecule designed to selectively modulate Kv3 potassium channels, which are important in central auditory processing.
Disease: age related hearing loss
Therapeutic area: Otorhinolaryngology
Country: USA
Trial
details: The study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss. The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo. Subjects will undergo a safety follow-up after the treatment period. Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.). The amount of drug in the blood will also be measured. It is expected that up to 100 people with age-related hearing loss may take part in the study. The study participants will be recruited at around 10-12 sites in the USA (NCT02345031)
Latest
news: * On April 27, 2015, Autifony Therapeutics announced that it has recruited the first subject in a Phase IIa study for treatment of Age Related Hearing Loss. This proof of concept study (called CLARITY-1) will explore the potential of AUT00063, Autifony’s first-in-class Kv3 potassium channel modulator, to improve hearing in the elderly by focusing on the discrimination of speech from background noise, which is an area of significant unmet medical need. The study will be conducted in around 14 key sites across the USA, with Dr Robert Frisina Jr, University of South Florida and director of the USF Global Center for Hearing & Speech Research, as Principal Investigator. The initiation of the trial also highlights the acceptance of Autifony’s first IND (Investigational New Drug) by the FDA, an important milestone for the company. In a Phase I study, AUT00063 showed a good safety and tolerability profile, and pharmacokinetics compatible with once daily oral dosing. In the Phase IIa study, one hundred subjects will undergo four weeks of once daily dosing, during which their hearing will be assessed using a speech-in-noise test, as well as other tests to probe central auditory processing. AUT00063 is also in development for the treatment of tinnitus, with a Phase IIa clinical trial in this indication already underway in the UK.
