Sensorian Pharma announced the U.S. FDA has approved an Investigational New Drug (IND) application for approval to begin a phase 2/3 trial of SENS-401 in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).
Sensorion initiated the phase 2/3 trial, AUDIBLE-S, in the beginning of 2019 in Europe, Canada, Israel, and Turkey. The interim safety results are expected at the end of 2019 and top-line data will be announced in mid-2020. AUDIBLE-S is a two-part, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of SENS-401 in approximately 450 subjects with severe or profound sudden sensorineural hearing loss. The subjects will receive SENS-401 or placebo tablets by mouth, twice a day (3 tablets in the morning and 3 tablets in the evening), for 4 weeks. The primary endpoint is the change in pure tone audiometry PTA (dB) in affected ear from baseline to the end of treatment visit (28 days).
Orphan drug designation was granted in Europe for SSNHL in November of 2016.
About Sudden Sensorineural Hearing Loss (or SSNHL)
SSNHL is also known as sudden deafness and belongs to the group of rare conditions that affect the inner ear. It is characterized by rapid (instant or in <72 hours) hearing loss typically unilateral and loss of >30 decibels (a 1000-fold reduction of sound perception). It is often accompanied by tinnitus and vertigo and most commonly affects people over 45 years of age.
SSNHL occurs with the destruction of sensory hair cells (sound detectors), the sensory neurons (conducting auditory information to the brain), or their connections. There are no treatments available for SSNHL.
About Arazasetron (SENS-401)
SENS-401 is a 5-HT3 receptor antagonist (setron family) with an additional undisclosed mode of action. It is a small molecule administered orally or by injection.