Date: 2016-01-06
Type of information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
Company: Sensorion (France)
Product: SENS-218
Action mechanism:
Disease: acute or chronic inner ear lesions either from vestibular or cochlear lesions
Therapeutic area: Otorhinolaryngology
Country: UK
Trial details:
Latest
news: * On January 6, 2016, Sensorion, a biotech specializing in the treatment of inner ear diseases, announced that it has received authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to launch a
Phase 1 clinical trial of its product candidate SENS-218 for the treatment of acute or chronic inner ear lesions either from vestibular or cochlear lesions.
This Phase 1 clinical trial aims to prove the safety and determine the pharmacokinetics profile of SENS-218 in Caucasian subjects. The Company plans to initiate the trial in the United Kingdom during the first quarter of 2016 with data expected by mid-year. This trial follows positive pre-clinical data with SENS-218 in acute vertigo and acute noise-induced hearing loss when compared to placebo. The Company expects to initiate its Phase 2a trial in the second half of 2016 either in a vestibular or a cochlear indication, in line with the Company’s previously disclosed development timeline.
