Sensorion Receives Approval From The UK Drug Agency To Initiate Clinical Trial Of SENS-218

Expect to Begin Enrollment of Phase 1 trial in Q1 2016

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotech specializing in the treatment of inner ear diseases, today announced that it has received authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to launch a Phase 1 clinical trial of its product candidate SENS-218 for the treatment of acute or chronic inner ear lesions either from vestibular or cochlear lesions.

This Phase 1 clinical trial aims to prove the safety and determine the pharmacokinetics profile of SENS-218 in Caucasian subjects. The Company plans to initiate the trial in the United Kingdom during the first quarter of 2016 with data expected by mid-year. This trial follows positive pre-clinical data with SENS-218 in acute vertigo and acute noise-induced hearing loss when compared to placebo. The Company expects to initiate its Phase 2a trial in the second half of 2016 either in a vestibular or a cochlear indication, in line with the Company’s previously disclosed development timeline.

Pierre Attali, Sensorion’s Chief Medical Officer, commented, “We are excited to be moving forward with our first international Phase 1 clinical trial of SENS-218 for the oral treatment of inner ear lesions. This study follows very encouraging pre-clinical data in vertigo or acute hearing loss. The trial authorization from the MHRA confirms the need for an improved therapy for these disorders and the potential for SENS-218 as a disease-modifier treatment option. With the initiation of this trial in the first quarter of 2016, we remain on track to begin our Phase 2a study in the second half of the year, enabling us to progress this program in an efficient manner.”

Laurent Nguyen, Sensorion’s Chief Executive Officer, concluded, “After SENS-111 that completed in late 2015 a phase 1b study, SENS-218 is the second inner ear oral treatment selected by our proprietary screening platform to enter a clinical trial, and further validates our research and development approach. We believe this evaluation process utilizing select criteria is the optimal way to develop a product portfolio with a high rate of success, and we look forward to assessing future opportunities. With significant near-term milestones and a sound cash position following our IPO in April 2015, as well as the long-term potential we believe we can create through our unique technology, Sensorion has strong momentum as we continue to progress with our development program.”

Upcoming events

• Presentation at Biotech Showcase, January 11, 2016 in San Francisco, CA
• Participation in BioMed Event hosted by Invest Securities, January 27, 2016 in Paris, France

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About Sensorion

Spun off from Inserm (the French institute of health and medical research) in 2009, Sensorion is a biotech that specializes in the treatment of pathologies of the inner ear such as acute vertigo, tinnitus and hearing loss. Backed by its pharmaceutical R&D experience and a comprehensive technology platform, Sensorion is developing three drug candidate programs for treating the symptoms of vertigo or tinnitus, for preventing 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 has a portfolio of 7 patent families, employs 15 staff and receives financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative.

For more information: 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.

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