Shots:
The P-IIa will evaluate the presence of SENS-401 (oral, BID) in the cochlea (perilymph) @7days prior to implantation in patients with hearing impairment receiving SENS-401 for 49days with the 1st patient enrolment expected in mid-2022. The Australian approval (Jun 7, 2022) was followed by approval in France
The study will also evaluate the 2EPs incl. change of hearing threshold from baseline till the end of the study at various frequencies & @2mos. follow up
SENS-401 was granted ODD by the US FDA for the prevention of platinum-induced ototoxicity in the pediatric population & by the EMA to treat sudden sensorineural hearing loss. The US FDA has also granted an IND clearance to SENS-401
Ref: Businesswire | Image: Businesswire
