Sensorion announced that the Phase II AUDIBLE-S clinical trial of its drug candidate SENS-401 (Arazasetron) to treat sudden sensorineural hearing loss (SSNHL) failed to meet the primary goal.
The asset failed to meet the primary endpoint of 15 decibels (dB), a substantial improvement in pure tone audiometry (PTA) in the affected ear from baseline versus placebo after four weeks of treatment.
That said, a sub-assessment in subjects with hearing threshold greater than or equal to 80dB, indicating severe hearing loss, demonstrated an enhanced response versus placebo at the two drug doses.
This subset accounted for 30% of the total trial population.
In the trial, SENS-401 was demonstrated to be safe and well-tolerated. Furthermore, the findings validate the data from the preclinical model of severe noise-induced hearing loss, the company said.
Sensorion will continue to analyse results from the trial, with the secondary endpoints data anticipated in mid-March this year.
SENS-401 is a small molecule that can be administered orally or through an injection. It is intended to offer protection and preserve the inner ear tissue from damage. The tissue damage could lead to progressive or sequelar hearing impairment.
The multicentre, double-blind, randomised, placebo-controlled trial enrolled 115 patients.
Subjects with severe or profound SSNHL were enrolled within 96 hours after the development of a sudden and severe hearing loss.
They were categorised to receive either 29mg and 43.5mg twice the daily oral dose of SENS-401 or a placebo.
Sensorion CMO Géraldine Honnet said: “We are encouraged by the SENS-401 activity data that showed a continuous improvement from day seven until day 28.
“We will review the full data as soon as possible and explore in particular the PTA comparisons at day 84 and the other secondary endpoints in the trial to determine the best development path for SENS-401.”
In February 2020, Sensorion obtained approval from the Independent Ethics Committee of Strasbourg in France to include military sites in the Phase II trial of SENS-401 for treating SSNHL.