Sensorion Announces Positive Results From SENS-218 Phase I Clinical Trial Undertaken In The UK

Confirmed safety and pharmacokinetic profile of SENS-218

MONTPELLIER, France--(BUSINESS WIRE)--Sensorion (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.”

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.

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.