Sensorion, a biotech company focused on the treatment of inner ear diseases, has received Orphan Drug Designation from the European Commission for SENS-401, its drug candidate for the treatment of sudden sensorineural hearing loss.
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) gave the positive opinion on October 17, 2016.
Laurent Nguyen, CEO of Sensorion, says: “The European Commission’s decision to grant SENS-401 orphan drug status is of strategic importance for Sensorion. Firstly, it allows us to position this molecule as the first orally-active candidate for treating sudden sensorineural hearing loss in Europe. Secondly, it represents a key element within the framework of our ongoing discussions with the regulatory authorities on the defining of the clinical development plan for this high-potential molecule.”
Orphan Drug Designation is granted to drug candidates under development with potential activity in a condition based on the the severity and rarity of the condition (affecting no more than 5 in 10,000 people in the EU), and the absence of alternative methods of prevention or treatment.
SENS-401, a small molecule administered orally, has been shown to have a protective effect on hearing in a model of noise-induced hearing loss that has been established as a benchmark test in studying sudden sensorineural hearing loss.
This condition is a brutal affliction involving a hearing loss of more than 30dB, usually unilateral and occurring rapidly over just a few days. It is perceptive deafness following the irreversible deterioration or destruction of neurons and certain hair cells in the inner ear. Approximately 4 in 10,000 Europeans are currently affected by this condition (i.e. approx. 205,0001 patients), for which no efficient drug exists.