Sensorion (FR0012596468 – ALSEN), a Montpellier, France-based biotech company developing drug treatments for inner ear diseases, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401. The drug is a therapy in development for the treatment of hearing disorders, for the prevention of Platinum-Induced Ototoxicity in pediatric patients. Platinum-based chemotherapies, in particular cisplatin, are commonly used to treat cancer, but reportedly induce severe hearing loss in 50-60% of treated patients, according to Sensorion. There is currently no approved pharmaceutical treatment available for this pathology.
Nawal Ouzren, CEO of Sensorion, said, “The FDA’s decision to grant Orphan Drug Designation to SENS-401 is another important milestone for our company, as we continue to advance our clinical and regulatory strategy. Hearing loss in pediatric oncology patients is one of the most frequent side effects of Cisplatin treatment, and may disable them [patients] for the rest of their lives. Based on its unique profile and the data generated to-date, we believe SENS-401 has the potential to be a safe and effective treatment for this serious medical condition where a significant unmet need exists. As such, we look forward to working with the FDA and EMA to set up an IND and design a Phase 2 clinical trial in order to evaluate SENS-401 in this indication.”
According to the company, SENS-401, R-azasetron besylate, is a drug candidate that aims to protect and preserve inner ear tissue when lesions can cause progressive or sequelar hearing impairments. SENS-401 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.
Sensorion has been listed on the Euronext Growth Paris exchange since April 2015.