MONTPELLIER, FRANCE — French biotech firm Sensorion, which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announced today that it has received the Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL). Sensorion initiated the Phase 2 clinical trial in this indication 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 mid-2020. In November 2016, SENS-401 received the orphan drug designation in Europe in SSNHL.
The European Medicines Agency (EMA) has accepted on the 28th of June 2019 the Pediatric Investigation Plan (PIP) for both developments in the treatment of severe sudden sensorineural hearing loss (SSNHL) and for prevention of ototoxicity caused by cisplatin (CIO) in pediatric populations.
SENS-401, arazasetron besylate, 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.