“We are delighted by this outcome which we regard as an important stage for Sensorion and young patients. Indeed, this approval will allow Sensorion to develop SENS-401 for pediatric patients suffering from severe hearing loss (SSNHL) but also in the prevention of ototoxicity caused by cisplatin. The loss of hearing in pediatric oncology patients often generates a lifelong handicap and is one of the main side effects of chemotherapy. We think that SENS-401 could be a safe and effective treatment for these severe lesions, a field in which there are substantial unmet medical needs. So we intend to continue discussions and propose a Phase 2 clinical trial protocol in order to investigate SENS-401 in this indication”, states Nawal Ouzren, Sensorion CEO.
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL). Sensorion initiated Phase 2 clinical trial in this indication at the start of 2019. The interim safety results are expected at the end of 2019. In November 2016, SENS-401 already received the orphan drug designation in Europe in SSNHL.
This data on otoprotection and the recovery of auditory capacity confirms the promising clinical potential of SENS-401 in sudden onset deafness, including when the treatment is not initiated immediately.
Source: Company Press Release