Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a clinical-stage biotechnology company, which specializes in the development of novel therapies to restore, treat, and prevent within the field of hearing loss disorders, and Cochlear Limited (ASX:COH), announce the initiation of a pilot study of the first-in-class small molecule drug SENS-401 (Arazasetron) in patients scheduled for cochlear implantation.
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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.
“We are excited Cochlear has decided to work with us to further develop SENS-401 in clinical studies” said Nawal Ouzren, CEO of Sensorion. “Our healthy volunteer studies and our ongoing Phase 2 study in sudden sensorineural hearing loss (SSNHL) have already demonstrated the safety of SENS-401, and our observations in preclinical models of cochlear implantation have established first promising efficacy signals. This new exploratory study aims to provide further clinical validation for the broadening of our pipeline, alongside our promising gene therapies, and will provide us with information on the drug’s potential beneficial effect on hearing outcomes achieved with Cochlear’s implantable devices.”
The results of Sensorion’s in vivo preclinical studies on the use of SENS-401 in conjunction with cochlear transplantation were encouraging, according to the companies’ announcement. 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.
“As the leader in the cochlear implant industry, we invest more than any other company in product innovation to optimize outcomes for those with hearing implants,” said Jan Janssen, Chief Technology Officer, Cochlear. “We believe the combination of cochlear implant technology and pharma therapies has the potential to enhance patient outcomes in terms of preservation of residual hearing and speech understanding. We recently announced the start of a pivotal clinical study with a dexamethasone-eluting cochlear implant electrode, which is a first in our industry. Through the collaboration with Sensorion in the SENS-401 study, we will gain further insights around potential combination therapies for people with severe to profound hearing loss.”
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 (IND) clearance from the US Food and Drug Administration (FDA).
Source: Sensorion, Cochlear