MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – 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.”
Sensorion specializes in the treatment of pathologies of the inner ear such as acute vertigo, tinnitus and hearing loss. The company was founded by Inserm (the French Institute of Health and Medical Research) and is utilizing its pharmaceutical R&D experience and comprehensive technology platform to develop drug candidate programs for treating hearing loss and the symptoms of vertigo and tinnitus, for preventing and treating complications associated with progressive lesions in the inner ear, and for preventing the toxicity of chemotherapy in the inner ear. Based in Montpellier, southern France, Sensorion received financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative. Sensorion is listed on Alternext Paris since April 2015. www.sensorion-pharma.com
This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward-looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the prospectus on which the French Financial Market Authority (AMF) granted its visa n° 15-114 on March 27, 2015 and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
1 Source: Alcimed, Sensorion
ISIN code: FR0012596468