Approval has been granted by the Australian authorities to allow a French company to progress with a clinical trial testing cochlear implants.
Montpellier-based Sensorion will start its proof of concept trial of SENS-401, a drug candidate that aims to protect and preserve inner ear tissue from damage.
Sensorion is a biotech company specializing in the development of therapies to restore, treat and prevent within the field of hearing loss disorders. The approval confirms a Phase 2a trial with SENS-401 for hearing preservation in patients who, due to having moderately severe to profound hearing impairment, are scheduled for cochlear implantation.
Australian hearing implants company Cochlear, will be running the trial with Sensorion. Sensorion has opened centers in Australia where Cochlear is based and the cooperation between the two companies started in December 2017.
The Australian approval follows confirmation in June this year that regulatory authorities in France have approved the trial.
This will be a multicenter, randomized, controlled, open-label trial to evaluate the presence of SENS-401 in the cochlear (perilymph) after seven days of twice-daily oral administration in adult participants prior to cochlear implantation.
The post Progress for hearing preservation trial after Australian approval granted appeared first on Labiotech.eu.
© Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.