Sensorion Reports Pipeline Update and First-Half-Year 2018 Results

Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN / PEA-PME eligible), a biotech company pioneering novel treatments of inner ear diseases, today announces its results for the first half of the year ending June 30, 2018, as well as its recent developments.

Sensorion obtained regulatory approval from international authorities (Europe and Canada)¹ to advance SENS-401 in Phase 2 for hearing disorders. SENS-401 has demonstrated otoprotective (hearing loss prevention) properties in various preclinical models. This has a significant commercial potential in an area of high unmet medical needs. The otoprotective effects may also benefit patients in the context of cochlear implants which is currently being investigated in collaboration with Cochlear, the global leader of implantable hearing solutions.

SENS-111 is still in Phase 2 clinical development for Acute Unilateral Vestibulopathy (AUV). AUV as the lead indication for SENS-111 was mainly driven by the need for a robust clinical pathway to demonstrate general proof of concept. Commercially the value of SENS-111 goes far beyond this AUV indication and resides in the opportunity to get the full label for vertigo.

Recruitment of suitable patients for the ongoing clinical trial in AUV has been more challenging than expected. Completion under the current protocol would potentially lead to a significant delay. Therefore, Sensorion decided to request a redesign of the current clinical protocol in order to reduce the sample size from 207 to around 100 while still generating efficacy signal. The expected data read out will now be in 2H 2019. This in addition to the ongoing Phase 2a safety trial comparing SENS-111 with Meclizine² for which data are expected by year-end will provide a robust data package showing the medical and commercial value of SENS-111.

‘It is an exciting time for Sensorion and its patients as we advance our clinical stage pipeline into Phase 2 for inner ear disorders,” said Nawal Ouzren, CEO of Sensorion. “Despite the necessary adjustments of SENS-111 phase 2 AUV trial intro a Proof-of-Concept study, I am pleased by the progress achieved over the last 12 months. Three active phase 2 programs, an additional investment of 8,65 Mio € by investors, the close partnerships with Professor Christine Petit as well as Cochlear, are testimony of our position and progress. With the adjustments we made today, we will be able to continue to focus our resources on areas of previously unmet medical needs while creating value for our investors.”