MONTPELLIER, FRANCE — Sensorion a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, has announced the enrollment of 115 patients for treatment in the company’s AUDIBLE-S study of the Sensorion’s first-in-class small molecule drug SENS-401 in patients with sudden sensorineural hearing loss (SSNHL).
Recruitment is now closed and the evaluation of the last recruited patients is ongoing.
With 115 patients enrolled, Sensorion has surpassed its target of 111 required under the revised statistical analysis plan for the AUDIBLE-S study. Enrolled patients receive 28 days of treatment and are followed for two additional months to complete the study.
The release of preliminary data is expected in January 2022 broadly in line with the expectations of top line data release around year end, as communicated in our press release in September.
“AUDIBLE-S is an important part of the development of SENS-401 as a pipeline asset for Sensorion and we are looking forward to sharing the top line results of the study in January 2022. As SENS-401 progresses through multiple clinical programs, Sensorion is building a clear picture of the clinical utility and market potential in treating and preventing diverse forms of hearing loss”
–Géraldine Honnet, CMO of Sensorion
Patients included in AUDIBLE-S have experienced severe sudden sensorineural hearing loss. The imminent completion of the AUDIBLE-S trial in SSNHL follows the acceptance by regulatory authorities of an amendment to the statistical analysis plan for the study announced with Sensorion’s H1 results on September 27th, 2021.
SENS-401 is also progressing in other indications. Sensorion and its partner Cochlear Limited, will submit a clinical trial application for SENS-401 in patients scheduled for cochlear implantation before year end. Separately, Sensorion will also submit a clinical trial application for a Phase 2 study of SENS-401 clinical study in cisplatin-induced ototoxicity (CIO) in Q4 2021.
SENS-401 (Arazasetron), is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment. A small molecule that can be taken orally or via an injection, SENS-401 has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population. It has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).
The Phase 2 AUDIBLE-S study is a randomized, double-blind, placebo-controlled multi-center Phase 2 study. Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period. Patients with severe or profound sudden sensorineural hearing loss are being recruited within 96 hours after onset of a sudden and severe hearing loss and randomized to either two treatment arms (29mg and 43.5mg twice a day oral dosing) or placebo. Change in pure tone audiometry PTA (dB) in the affected ear from baseline to the end of treatment visit is the primary outcome measure of the study.