Sensorion, Montpellier, France, a clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat, and prevent inner ear diseases such as hearing loss, tinnitus, and vertigo, announced 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 its preclinical data and clinical development plan.
Federal law prohibits the transportation and distribution of drugs across state lines, and the IND clearance allows Sensorion to ship the investigational drug to clinical investigators in many states.
SENS-401 is under development in the treatment of sudden sensorineural hearing loss (SSNHL). Sensorion initiated the Phase 2 clinical trial in this indication at 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 mid-2020. In November 2016, SENS-401 received the orphan drug designation in Europe in SSNHL. In December 2017, Sensorion announced that it received $1.9 from Cochlear Investment Ltd to finance the preclinical combination studies that evaluate SENS-401’s therapeutic effect on hearing outcomes achieved with Cochlear’s implantable devices.
On June 28, 2019, the European Medicines Agency (EMA) accepted 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.
Sensorion is also developing Seliforant (formerly SENS-111), which is currently being studied in an ongoing Phase 2 trial for the treatment of acute unilateral vestibulopathy, a debilitating disease of the inner ear.