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

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

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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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