Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announces that it presented preclinical results for SENS-401 in the prevention of Cisplatin-induced ototoxicity during a podium presentation at the Combined Otolaryngology Spring Meetings (COSM), which took place in San Diego, CA from April 26 to 30, 2017.

COSM is a major annual scientific event bringing various American ENT societies together. It offers an international exposure to all scientific work presented by clinicians and researchers operating within this field.

Title of the podium presentation: Oral Administration of Clinical Stage Drug Candidate SENS-401 Effectively Reduces Cisplatin-induced Hearing Loss in Rats

In this study, Sensorion evaluated the preventive activity of SENS-401 on Cisplatin toxicity. Cisplatin is a frequently-used chemotherapy drug, particularly in children, with side effects that cause severe hearing loss in 50% to 60% of patients treated with the drug. The study consisted of an in vivo animal model that was orally administered SENS-401 immediately prior to, and for 14 days following, the intravenous infusion of Cisplatin.

The three doses of SENS-401 that were evaluated (6.6, 13.2 and 26.4 mg/kg/day) demonstrated statistically significant activity compared to the placebo:

  • an elevation of auditory brainstem response (ABR) thresholds of between 10 and 30 dB (p<0.01)
  • an improvement in distortion product otoacoustic emission (DPOAE) amplitudes of between 10 and 20 dB (p<0.05)
  • significantly higher survival rate for sensorineural hair cells in the treated group (p<0.001)

Pierre Attali, Sensorion’s Chief Medical Officer, comments: “Following its previously demonstrated activity in acoustic trauma, Cisplatin IV infusion-induced hearing loss represents the second preclinical model in which orally active SENS-401 has shown to have a statistically significant effect. Acceptance of these data for an oral presentation at COSM is indicative of the importance of these results and the potential of SENS-401 as a treatment for patients suffering from inner ear lesions following Cisplatin-based chemotherapy, an indication for which there is currently no effective drug approved. We intend to continue pre-clinical development of SENS-401 on our screening platform in order to evaluate the opportunity of developing this drug in this new indication.”

Nawal Ouzren, CEO of Sensorion, adds: “I am delighted the work performed by Sensorion’s team is regularly exposed in first tier congresses in the field of inner ear. This demonstrates their high quality. I will contribute all my experience to Sensorion’s Research and Development projects in all the indications we cover in the inner ear field. We aim at building a solid and diversified portfolio of drug candidates. Ototoxicity represents a particularly interesting therapeutic area and a significant unmet medical need.”

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About SENS-401

SENS-401, R-azasetron besylate, is a drug candidate currently undergoing a phase I clinical testing that aims to protect and preserve inner ear tissue when lesions are present that can cause progressive or sequelar hearing impediments. It is one of the two enantiomer forms of SENS-218, azasetron, a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone. Enantiomers are molecules 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 completed to date 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 and has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss.

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 candidates for treating and preventing hearing loss and the symptoms of bouts of vertigo and tinnitus. The first two programs are respectively in phase 1 (SENS-401) and phase 2 (SENS-111) clinical testing. 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 Alternext Paris exchange 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.

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