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.
Patients will receive SENS-401 for a total of 49 days. It will also assess secondary outcome measures, including the change of hearing threshold from baseline to the end of the study in the implanted ear at several frequencies and a two-month period of follow-up is required. The first patient enrolment is anticipated by mid-2022.
Géraldine Honnet, chief medical officer of Sensorion said: “Approval by Australian authorities to progress with our clinical trial of SENS-401 for residual hearing preservation in patients scheduled for cochlear implantation paves the way for us to begin this important clinical trial.
“We have seen compelling clinical data in our recently completed Phase 2 study which supports our confidence that prescribing SENS-401 with cochlear implants can bring significant clinical benefits to patients suffering from hearing loss. We look forward to working with Cochlear to enrolling the first patient shortly.”
At the beginning of 2021, Sensorion released positive preclinical data demonstrating that the combination of its SENS-401 molecule alongside a cochlear implant helped reduce loss of residual hearing at a frequency located beyond the electrode array. Preservation of natural hearing is particularly important in speech recognition. Preclinical studies were undertaken in collaboration with the global leader in implantable hearing, Cochlear Ltd.
The drug candidate (SENS-401/Arazasetron) strives to protect and preserve inner ear tissue from damage that can cause progressive or sequela hearing impairment. A small molecule that can be taken orally or via an injection, SENS-401 has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population. It has received Investigational New Drug (IND) clearance from the FDA.