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French biopharmaceutical company Sensorion has announced a delay in the ongoing Phase II trial of SENS-401 (Arazasetron) to treat Sudden Sensorineural Hearing Loss (SSNHL) due to slow recruitment rate.
The company said that the patient recruitment rates of the trial are affected by the rapidly evolving Covid-19 scenario.
Data from the AUDIBLE-S multi-centre, randomised, double-blind, placebo-controlled trial should be available by the middle of next year, later than earlier announced.
Sensorion CEO Nawal Ouzren said: “The AUDIBLE-S trial is progressing but we are obviously disappointed that the recruitment rate is at a slower pace than our original expectations.
“An important factor also impacting recruitment in our trial is the reprioritisation of emergency room resources due to the current Covid-19 situation. As the epidemic situation is rapidly changing, our revised estimate is for a top-line data readout by mid-year 2021.
“We will continue to monitor the situation and will provide updates should there be significant changes to this timeline.”
Subjects with severe or profound SSNHL are enrolled for the AUDIBLE-S Phase II trial and will receive a 43.5mg dose, a 29mg dose or a placebo twice a day for four weeks.
The change in pure tone audiometry PTA (dB) in the affected ear from baseline to the end of treatment visit is the primary endpoint of the study.
SENS-401 is a drug candidate intended for the protection of inner ear tissue from damages that can lead to progressive or sequelae hearing impairment.
The drug obtained Orphan Drug Designation in Europe for the treatment of SSNHL and Orphan Drug Designation from the US Food and Drug Administration (FDA) for the prevention of platinum-induced ototoxicity in the paediatric population.
The FDA has also granted Investigational New Drug (IND) clearance to SENS-401.
In February, Sensorion secured approval from the Independent Ethics Committee of Strasbourg in France to add new military sites to the Phase II clinical trial of SENS-401.