Sensorion Selects New Drug Candidate, SENS-401, to Treat Vestibular and Auditory Disorders Associated with Inner Ear Lesions

Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announced that it has selected SENS-401, an enantiomer of SENS-218, as a new drug candidate for treating vestibular and auditory disorders resulting from lesions of the inner ear.

SENS-401 is a new drug candidate with substantial potential derived from SENS-218.

SENS-218 is a racemic compound containing 2 enantiomers, which are compounds that have an identical chemical structure but a different configuration in space, i.e. they are mirror images of each other similar to a person’s left and right hands. Two enantiomers can have different biological properties.

Sensorion has synthesized one of the two enantiomers, called SENS-401, and discovered that it has superior properties to SENS-218. More precisely, comparative preclinical experimental studies carried out on Sensorion’s screening platform have shown a superior pharmacokinetic and efficacy profile for SENS-401 than that obtained on animal models for either SENS-218 or the second enantiomer.

Preliminary results from the preclinical studies with SENS-401 in hearing loss resulting from acoustic trauma will be presented at the 46^th Annual Meeting of the Society for Neuroscience (SfN), Neuroscience 2016, which will be held on November 12-16, 2016 in San Diego, California.

The pharmacological profile of SENS-401 in humans was assessed during the phase 1 clinical trial on SENS-218 conducted in the United Kingdom over the first half of 2016, which confirmed positive clinical tolerance of the racemic compound.

SENS-401 will also strengthen Sensorion’s intellectual property portfolio, and the Company has filed new patent applications to seek commercial exclusivity for SENS-401 until 2036.

Based on these factors, Sensorion has decided to select SENS-401, instead of 218, as its final drug candidate for treating lesions of the inner ear. Sensorion is assessing various options for its development, and will present its clinical strategy in the near future.

Pierre Attali, Sensorion’s Chief Medical Officer, comments: "With SENS-401 we are seizing an opportunity to develop an enantiomer of a known and well-tolerated racemic compound that presents a better drug candidate profile than the racemate. The clinical data supports the development of this orally-active molecule for the treatment of inner ear lesions where there is a clear medical need. Additionally we are seeking enhanced and extended intellectual protection for SENS-401.”

Laurent Nguyen, CEO of Sensorion, concludes: "The progress made with our anti-lesion program is decisive in two ways. Developing the enantiomer of a known compound is a strategy that has already been successfully used for other drugs, notably in the fields of allergies, peptic ulcers and depression. In addition to its clinical advantages and shortened development period, it provides efficient protection for the future use of this compound, which will be considered a new chemical entity. The discovery of SENS-401’s properties is further proof of the ability of our screening platform’s to identify new and easy to administer drug candidates in order to address the treatment and prevention of debilitating inner-ear pathologies.”

There is currently no efficient drug available to treat people suffering from inner ear lesions, which affect some 21 million patients worldwide¹. Hearing loss resulting from acoustic trauma accounts for more than half of these patients.

???

About SENS-401

SENS-401 is a drug candidate that aims to protect and preserve inner ear tissue from lesions that can cause vertigo and gradual or sudden hearing loss. It is one of the two enantiomer forms of SENS-218, which is a racemic product. Enantiomers are products that have 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. The pharmacological and pharmacokinetic tests undertaken have shown a superior drug candidate profile for SENS-401 compared with the other enantiomer or the racemic form. SENS-401 is a small molecule that can be taken 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 Document de référence registration document filed with the Autorité des marchés financiers (AMF- French Financial Market Authority) on July 28, 2016 under n°R.16-069 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

View source version on businesswire.com: http://www.businesswire.com/news/home/20160929006160/en/