French inner ear diseases company Sensorion has secured the investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to move ahead with the clinical trial of SENS-401 (arazasetron besylate) for the treatment of sudden sensorineural hearing loss (SSNHL).
The investigational new drug clearance was granted based on preclinical data and clinical development plan. SENS-401 was granted orphan drug designation from the FDA for the prevention of platinum-induced ototoxicity in pediatric population.
Sensorion began a phase 2 clinical trial in sudden sensorineural hearing loss this year in Europe, Canada, Turkey, and Israel. The interim safety results are anticipated to come out at the end of this year, while top line data will be released mid-2020. SENS-401 was granted the orphan drug designation in Europe for the indication in In November 2016.
In late June 2019, the European Medicines Agency (EMA) accepted the pediatric investigation plan (PIP) for developments of the investigational drug in the treatment of severe sudden sensorineural hearing loss (SSNHL) and for prevention of ototoxicity caused by cisplatin (CIO) in pediatric populations.
According to Sensorion, SENS-401 has been designed to provide protection and preserve inner ear tissue from damage that can lead to progressive or sequelar hearing impairment. The investigational drug is a small molecule that can be taken orally or through an injection.