SENS-401 is being developed to treat sudden sensorineural hearing loss. Credit: Shai Barzilay.

Biotech firm Sensorion has received approval from the Independent Ethics Committee of Strasbourg in France to add new military sites to the Phase II clinical trial of SENS-401 to treat sudden sensorineural hearing loss (SSNHL).

SENS-401 is an investigational, small molecule drug intended to protect and preserve inner ear tissue against damage that can lead to progressive or sequelar hearing impairment.

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Named AUDIBLE-S, the multi-centre, randomised, double-blind, placebo-controlled Phase II trial is being conducted to evaluate a 43.5mg and 29mg twice-daily dose of SENS-401 for four weeks in patients suffering from severe or profound SSNHL.

The primary endpoint of the study is the change in pure tone audiometry PTA (dB) in the affected ear from baseline to day 28.

The new sites will enrol military personnel who were exposed to impulse noise and are suffering from hearing loss. Sensorion noted that the participation of the French Army makes AUDIBLE-S the largest military trial in the country.

The French Government provided €10.8m in funding to the PATRIOT consortium for the development of SENS-401 in SSNHL. Sensorion is also eligible for additional funding of up to €5.6m.

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Led by Sensorion, the consortium involves the French Biomedical Research Center (IRBA), Institut Pasteur, and Electronique du Mazet.

SENS-401 holds orphan drug designation in Europe for the treatment of SSNHL and in the US to prevent platinum-induced ototoxicity in children. It also secured investigational new drug (IND) clearance from the US Food and Drug Administration (FDA).

In December last year, Sensorion’s SENS-111 failed to meet the primary efficacy endpoint in the Phase IIb proof-of-concept trial for acute unilateral vestibulopathy (AUV/vestibular neuritis.

SENS-111 is a histamine type 4 receptor antagonist.