Sensorion SA

11/07/2018 | Press release | Distributed by Public on 11/07/2018 00:39

Sensorion announces presentation of SENS-401 poster at society for Neuroscience 2018 annual meeting. Read

Press release

Sensorion Announces Presentation of SENS-401 Poster at

Society for Neuroscience 2018 Annual Meeting

Preclinical data suggest efficacy of SENS-401 is not affected by concomitant administration of a corticosteroid

Adds to evidence supporting use of SENS-401 in sudden sensorineural hearing loss (SSNHL)

Phase II trial of SENS-401 in SSNHL is ongoing

Montpellier, November 7, 2018 - Sensorion (FR0012596468 - ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announced the presentation of a poster at the 2018 Neuroscience meeting, entitled "Treatment of Severe Noise-Induced Hearing Loss by Oral SENS-401 is not Affected by Concomitant Prednisolone Administration."

Off-label use of corticosteroid therapy is not currently recommended in the clinical practice guidelines for sudden sensorineural hearing loss (SSNHL), and recent meta-analysis (Crane et al. 2015) concluded no significant treatment effect.

However, as no approved pharmaceutical treatment currently exists for SSNHL, corticosteroids remain an accepted standard-of-care.

The investigators evaluated whether co-administration of prednisolone at human equivalent dose in a rat model of severe acoustic trauma-induced SSNHL affected otoprotective treatment with SENS-401. The results suggest that the efficacy of otoprotective treatment with SENS-401 is not affected by concomitant administration of a standard-of-care corticosteroid following a clinical treatment regimen at human equivalent dose.

"These new data add to the evidence supporting the use of SENS-401 as a potential first-in-class therapy for treatment of SSNHL," says Nawal Ouzren, Sensorion's Chief Executive Officer. "Sensorion has taken this information into account when designing the phase II trial in SSNHL for which it has already received authorization in Europe and Canada."

The details of the poster presentation are as follows:

Abstract Title: Treatment of Severe Noise-Induced Hearing Loss by Oral SENS-401 is not Affected by Concomitant Prednisolone Administration

Session Title:

Auditory and Vestibular Systems: Hair Cells and the Periphery

Session Number:

482

Session Time:

11/6/2018 8:00:00 AM - 11/6/2018 12:00:00 PM

About the Society for Neuroscience Annual Meeting

The Society for Neuroscience is the world's largest organization of scientists and physicians devoted to understanding the brain and nervous system. The 2018 annual meeting is held in San Diego, California from Nov 3-7.

About SENS-401

SENS-401, R-azasetron besylate, is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairments. A small molecule that can be taken orally or via an injection, SENS-401 has received Orphan Drug Designation in Europe for thePress release treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population.

About Sensorion

Sensorion is a biotech company pioneering novel treatments of inner ear diseases such as severe vertigo, tinnitus or hearing loss. Two products are currently in the clinical development stage: Seliforant, in Phase 2 in acute unilateral vestibulopathy and arazasetron (SENS-401), which has entered in Phase 2 in sudden sensorineural hearing loss in the second half of 2018. 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 first-in-class easy-to administer, notably orally active, drugs for treating and preventing hearing loss and the symptoms of bouts of vertigo and tinnitus. Based in

Montpellier, Southern France, Sensorion has received financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative.

Sensorion has been listed on the Euronext Growth Paris exchange since April 2015.

www.sensorion-pharma.com

Contacts

Sensorion Nawal Ouzren CEO [email protected] Tél : 04 67 20 77 30

Relations Press - Alize RP Tatiana Vieira [email protected]zerp.comLabel : SENSORION ISIN : FR0012596468 Mnemonic : ALSENInvestor Relations - International LifeSci Advisors LLC

Hans Herklots - Managing Director [email protected] Tél. : +41 79 367 6254

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 référence registration document filed with the Autorité des Marchés Financiers (AMF French Financial Market Authority) on September 6th, 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.