MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces preclinical data showing that the combination of its SENS-401 molecule with cochlear implants reduced loss of residual hearing at a frequency located beyond the electrode array. SENS-401 also showed a statistically significant electrode impedance reduction. The impedance is associated with electrode array insertion trauma and increased foreign body response around the electrode array.
“Cochlear implants are highly effective in treating severe to profound hearing loss. But preserving acoustic hearing in patients with less severe forms of hearing loss who receive cochlear implants could provide a substantial benefit to this population,” said Nawal Ouzren, CEO of Sensorion. “These preclinical results are very encouraging; they show that SENS-401 may have the potential to assist cochlear implant patients with an otoprotective effect, improving outcomes.”
The preclinical program was conducted as part of a collaboration between Sensorion and Cochlear (ASX: COH), the global leader in implantable hearing solutions. The study was designed to determine whether SENS-401 has the potential to improve preservation of residual acoustic hearing after cochlear implantation. Either SENS-401 or a placebo was delivered via an eluting electrode in an established pre-clinical model of cochlear implantation. The primary outcome of the study was functional hearing loss, assessed via Auditory Brainstem Response (ABR) thresholds.
In this placebo-controlled preclinical study, more hearing was retained at 34 weeks (at a frequency located beyond the electrode array) where the cochlear implant was combined with SENS-401 than where the implant was combined with placebo. Hearing loss was a statistically significant 9.6 decibels lower in the SENS-401-treated group compared to placebo. There was a positive, but not statistically-significant trend at other frequencies in favor of the SENS-401 group. Encouragingly the SENS-401 treated group also showed a statistically significant 2.2kOhm reduction in electrode impedance, averaged across stimulation channels, compared to the placebo group.
Sensorion and Cochlear are now assessing next steps, including options for clinical studies for SENS-401 in cochlear implant patients.
Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL). Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. In the second half of 2019, Sensorion initiated two preclinical gene therapy programs aimed at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin. The Company is potentially uniquely placed, through its platforms and pipeline of potential therapeutics, to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders, a significant global unmet medical need.
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