ALSEN Sensorion SAS

Sensorion Announces an Oral Presentation of New SENS-401 Preclinical Data at ISIET 2019 in Hannover

Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, has contributed an oral presentation at the 2nd International Symposium on Inner Ear Therapeutics (ISIET 2019) held in Hannover (Germany), from the 4th to the 6th of November, 2019.

In the session “Outcome measures and clinical trials”, the talk entitled “Oral SENS-401 Reduces Central Auditory Neuronal Loss after Acoustic Trauma in NMRI Mice” presented studies performed in collaboration with researchers at the Unfallkrankenhaus Berlin & Charité Medical School (Berlin, Germany) that investigated the potential of orally administered SENS-401 to protect against loss of central auditory neurons after acoustic trauma induced hearing loss in NMRI mice.

Most research and models of sensorineural hearing loss focus on peripheral damage and potential therapeutic targets in the peripheral auditory structures of the cochlea. However, damage to central auditory structures can contribute significantly to e.g. tinnitus, reduced speech intelligibility and other central auditory processing deficits.

To determine the potential for protection against central auditory cell death in an established model, SENS-401 or placebo was administered orally to NMRI mice for 14 days after exposure to acoustic trauma. Subsequently, the number of surviving neurons in the central auditory structures of the ventral cochlear nucleus (VCN) and inferior colliculus (IC) were determined using histological methods. SENS-401 treatment significantly increased the number of surviving neurons in the VCN and IC compared to placebo treatment.

These results suggest that SENS-401, in addition to the ability to preserve sensory cells and hearing function peripherally in the cochlea, could also reduce the loss of central auditory neurons in sensorineural hearing loss pathologies. This could confer additional clinical treatment benefits such as reduced incidence/severity of tinnitus or central auditory processing deficits for patients.

About SENS-401

SENS-401, arazasetron besylate, 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).

About Sensorion

Sensorion is a pioneering clinical-stage biopharmaceutical company, which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, vertigo and tinnitus. Its clinical-stage portfolio includes two phase 2 products: Seliforant (SENS-111) under investigation for acute unilateral vestibulopathy and Arazasetron (SENS-401) for sudden sensorineural hearing loss (SSNHL).

Sensorion has built a unique R&D technology platform to expand its understanding of the physiopathology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates. The Company has also identified biomarkers to improve diagnosis and treatment of these underserved illnesses.

Sensorion is launching in the second half of 2019 two preclinical gene programs aiming 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 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 need in medicine today.

Label: SENSORION

ISIN: FR0012596468

Mnemonic: ALSEN

Disclaimer

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 "Document de reference" registration document filed with the "Autorité des Marchés Financiers" (AMF French Financial Market Authority) on September 7th, 2017 under n°R.17-062 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.

EN
07/11/2019

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