Sensioron Says Pandemic Is Slowing Its Clinical Trial Enrollment

Sensorion said results from a mid-stage study of its experimental therapy to treat sudden sensorineural hearing loss will be delayed because patient recruitment rates are slower than expected as a result of the COVID-19 pandemic.

Photo: Nawal Ouzren, CEO of Sensorion

The company said it now expects top-line data from the trial of its experimental therapy SENS-401 will be available by mid-year 2021. The trial results had been expected before year-end.

“The AUDIBLE-S trial is progressing, but we are obviously disappointed that the recruitment rate is at a slower pace than our original expectations”, said Nawal Ouzren, CEO of Sensorion. “An important factor also impacting recruitment in our trial is the reprioritization of emergency room resources due to the current COVID-19 situation.

Ouzren noted that the situation is rapidly changing and said the company will provide updates on the situation if there are significant changes to the timeline.

Sudden sensorineural hearing loss is a rare condition with an unknown cause that results in a hearing loss of more than 30 decibels. It can happen at once or over several days.

SENS-401 is a drug that is designed to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment. SENS-401 has received Orphan Drug designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug designation from the U.S. Food and Drug Administration for the prevention of platinum-induced ototoxicity in the pediatric population.

The AUDIBLE-S phase 2 study is a multi-center, randomized, double-blind, placebo-controlled study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss (SSNHL). The primary endpoint of the study is change in pure tone audiometry PTA (dB) in the affected ear from baseline to the end of treatment visit (day 28).

Though there has not been a spate of similar announcements from drug developers, it does suggest efforts to run clinical trials may become impeded as hospitals feel the stress and strain of responding to the pandemic.

“We are doing our utmost to ensure we can provide the clinical data set as quickly as possible, so that we can define the next steps with SENS-401 within the field of SSNHL and use our scientific know-how and expertise to develop much needed treatments for people suffering from hearing loss disorders,” says Géraldine Honnet, CMO of Sensorion.

Author: Rare Daily Staff