Sensorion Announces Positive Results From SENS-218 Phase 1 Clinical Trial Undertaken in the UK

Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN / PEA-PME eligible), a biotech company specializing in the treatment of inner ear diseases, today announced positive results from the phase 1 clinical trial undertaken on its SENS-218 drug candidate that aims to treat lesions of the inner ear, whether vestibular or cochlear.

SENS-218 is an orally-administered drug already marketed in Asia for other indications than those intended by Sensorion. The Company has shown, thanks to its screening platform, this compound’s efficacy in experimental models for vertigo (vestibular lesions) and noise-induced hearing loss (cochlear lesions).

The phase 1 clinical trial was carried out in the United Kingdom on 24 healthy Caucasian volunteers with the aim of assessing SENS-218’s tolerance when administered in a single dose, as well as the pharmacokinetic profile of its racemic form and its two enantiomer forms¹.

This trial confirmed the compound’s excellent clinical tolerance at higher doses than those commonly used in Asia, and also confirmed a similar pharmacokinetic profile to that observed in Asian patients, suggesting that its clinical development could be expanded to all patient populations regardless of their ethnicity.

Pierre Attali, Sensorion’s Chief Medical Officer, comments: "The positive results obtained from the phase 1 clinical trial on SENS-218 represent a major milestone in the development of new drugs for treating lesions of the inner ear where there is a critical unmet need for patients. We now have important new data to prepare the next proof-of-concept studies in humans and select the indications that should be explored in priority. This trial has also allowed us to document enantiomer derivatives of SENS-218 that could have substantial potential from a clinical and intellectual property perspective.”

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About SENS-218

SENS-218 is a drug candidate that aims to protect and preserve inner ear tissue from lesions that can cause vertigo as well as gradual or sudden hearing loss. It has been selected based on its pharmacological activity tested on Sensorion’s screening platform, its distribution in the inner ear and its known pharmacokinetic and clinical tolerance. SENS-218, a racemic compound with two enantiomer forms, is a small molecule that can be taken either orally or via an injection.

About Sensorion

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 first-in-class easy-to-administer, notably orally active, 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

Name: SENSORION
ISIN code: FR0012596468
Ticker: 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 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 A racemic compound contains at least 2 enantiomer forms, which are compounds with an identical chemical structure but a different configuration in space, i.e. they are mirror images of each other like a person’s left and right hands. Two enantiomers can have different biological effects.

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