Investors and patients will learn more about the future of Sensorion’s sudden hearing loss drug in March, once the French biotech has a clearer picture of an unsuccessful mid-stage study.
The oral small molecule, dubbed SENS-401 and arazasetron, failed to significantly improve pure-tone audiometry, which measures hearing sensitivity, in patients’ affected ear compared to baseline. The phase 2 trial tested arazasetron in sudden sensorineural hearing loss, a hearing emergency in which patients lose 30 decibels or more on at least three frequencies over three days.
Although it missed the primary endpoint, Sensorion has yet to decide the fate of the arazasetron development path. The biotech will await more detailed results from the Audible-S trial, including data on secondary endpoints. Once the data is released in mid-March, the company will unveil its development plans, Sensorion (PDF) said Monday.
Biotech shares have halved since the news broke on Monday, falling from $1.82 on Friday to 88 cents on Wednesday. The sudden hearing loss failure clouds the drug’s future in two other conditions and creates problems for a biotech that has nothing else in the clinic. Sensorion has yet to test three other pipeline products, which are gene therapies, in humans.
RELATED: Frequency Therapeutics Regroups as Hearing Loss Drugs Fail in Phase 2
Sensorion did not detail the study’s secondary endpoints, nor are they listed in the federal trials database. The drug was given twice a day, at 29 mg or 43.5 mg, for four weeks. Patients were recruited within 96 hours of onset.
The pandemic impacted the data timing of the study’s key results, and the company also changed the statistical analysis plan last year to reduce the trial’s sample size, said Sensorion.
The company said a subset of patients with severe hearing loss, including 30% of the 115 patients in the trial, showed better responses compared to placebo at both dose levels.
There is no therapeutic treatment for sudden sensorineural hearing loss. The disease is difficult to diagnose: at initial presentation, only 10 to 15 percent of patients are reported to have it, according to a review of the disease in the Journal of Otology.
The company is “understandably disappointed,” CEO Nawal Ouzren said in a statement, but Sensorion sees potential in secondary metrics.
Sensorion is also developing the drug to protect inner ear tissue from damage, with the aim of stopping progressive hearing loss. In addition to the Audible-S study in sudden sensorineural hearing loss, Sensorion is studying the drug in hearing preservation after cochlear implantation and cisplatin-induced ototoxicity, in which cisplatin chemotherapy results in severe and permanent hearing loss.
French biotech is not the first to flinch in sensorineural deafness. Frequency Therapeutics’ treatment did not beat placebo in a Phase 2a study last March.