Sensorion’s SENS-401 Receives Australia’s Approval for the Initiation of Proof-of-Concept Trial to Treat Hearing Impairment
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
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