9 September 2021 - - France-based biotechnology company Sensorion (PAR: ALSEN) (FR0012596468 ALSEN) and implantable hearing solutions specialist Cochlear Ltd. (ASX: COH) have initiated a pilot study of the first-in-class small molecule drug SENS-401 (Arazasetron) in patients scheduled for cochlear implantation, the companies said.

The study will be sponsored by Sensorion and the proposed design is expected to be submitted to the regulatory authorities in the second half of 2021.

The results of Sensorion's in vivo preclinical studies on the use of SENS-401 in conjunction with cochlear transplantation were encouraging.

In an established preclinical model, the combination of SENS-401 with cochlear implants preserved residual acoustic hearing at statistically significant levels at a frequency located beyond the electrode array, compared to placebo.

In the preclinical study, drug or placebo was delivered via an eluting electrode.

The new clinical study will explore the potential efficacy of SENS-401 in combination with cochlear implants.

SENS-401 (Arazasetron), is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar 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 clearance from the US Food and Drug Administration.

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 an R and 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.

Sensorion has launched three gene therapy programs, currently at preclinical stage, aimed at correcting hereditary monogenic forms of deafness including deafness caused by a mutation of the gene encoding for Otoferlin, hearing loss related to gene target GJB2 as well as Usher Syndrome Type 1 to potentially address important hearing loss segments in adults and children.

Since 1981, Cochlear has provided more than 600,000 implantable devices, used in more than 180 countries, to hear.