MONTPELLIER, France--(BUSINESS WIRE)--Sensorion (Paris:ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announced that full data from its preclinical trial for SENS-218, its product candidate for the treatment of severe hearing loss have been presented at the Association for Research in Otolaryngology Mid-Winter Meeting held in San Diego, CA on February 20, 2016.
First pharmacological data were previously presented at the Neuroscience 2015 annual meeting, under the abstract entitled “Effective protection against severe noise-induced hearing loss by a small molecule clinical drug candidate following daily, post-trauma systemic administration”.
This was a preclinical, proof-of-concept in vivo trial in animals affected by acute bilateral sensorineural hearing loss. The trial design consisted of animals which were exposed to a 120 dB noise level for 2 hours and then randomized to 14 consecutive days of treatment with either the systemically administered placebo or a Sensorion drug candidate from the small-molecule SENS-200 program. All endpoint measurements were improved in the group treated with SENS-218 in comparison with placebo on Day 14. The level of hearing loss was reduced by an average of 50% with SENS-218, showing a recovery of 33.4 dB versus 16.7 dB with placebo (from the same initial level of hearing loss) and a reduction of the average loss of sensory outer hair cells in the most sensitive regions of the cochlea by around 36% on average.
Complementary pharmacokinetic data from the pre-clinical trial were presented at the Association for Research in Otolaryngology (ARO) Meeting under the abstract entitled “Effective Protection Against Severe Noise-Induced Hearing Loss by an Inner Ear Penetrating, Small Molecule Clinical Drug Candidate Following Daily, Post-Trauma Systemic Administration” by Dr. Jonas Dyhrfjeld-Johnsen, Sensorion’s Head of Pharmacology.
This new data show that systemic administration of SENS-218 resulted in significant concentrations of SENS-218 in perilymph, the fluid located within the cochlea, and in tissular inner ear. It shows the molecule’s suitability for an oral or IV way of administration targeted by the Company.
To date, there is no drug available to treat patients suffering from hearing loss resulting from acoustic trauma, which affects some 11 million patients worldwide1. Given that the corticosteroids-based treatments that are sometimes used for this pathology only have a limited or insignificant effect, there is a substantial need for efficient and easy-to-administer drugs.
Pierre Attali, Sensorion’s Chief Medical Officer, says: “Acceptance of this study for presentation at the ARO meeting is further validation of the science behind our SENS-200 program. These data support the Sensorion approach to treat inner ear disorders by systemic (oral or IV) administration of drug candidate for the benefit of a large patient population that suffers from acute hearing loss. We look forward to advancing the clinical development of SENS-218 currently entering phase 1 and providing our investors and the medical community with updates on our data as we progress.”
1 Source: Alcimed, Sensorion
ISIN code: FR0012596468