New data confirms attractive safety profile of drug against acute inner ear tinnitus

Auris Medical is a biotechnology company developing specific pharmaceutical compounds for the prevention or treatment of inner ear disorders, an area of great unmet medical need. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations.

At the TRI Tinnitus Conference, key safety outcomes from a second study, a Phase IIb clinical trial, were presented for the first time. The Phase IIb study confirmed the previous results from the Phase I/II trial and provided a wealth of additional safety and local tolerance data. As expected, the occurrence of clinically significant hearing loss was low, and there were no statistically significant differences between treatment groups. On average, hearing thresholds improved slightly over the 90 day observation period.

There were no statistically significant and/or clinically significant differences in the frequency, intensity or relationship of adverse events between treatment groups in the Phase IIb study. Most adverse events were mild or moderate in intensity, and local rather than systemic. As expected, the majority of them were reported for a transient deterioration in hearing and tinnitus perception, which was mostly related to the tympanotomy performed prior to the injection. They usually resolved upon full closure of the eardrum. At D7, just 7% of eardrums were not fully closed, yet. Other procedure-related transient adverse events like vertigo, ear pain or inflammation were observed only rarely. Serious adverse events were also low in numbers and all considered unrelated or unlikely related.

“The accumulated data and experiences from the clinical trials reveal and confirm an attractive safety profile for AM-101,” stated Dr. Mühlmeier, who has been involved in the entire clinical development programme with AM-101 as a Principal Investigator. “They also demonstrate excellent tolerance of the AM-101 formulation in the middle ear and, importantly, also show high acceptance of intratympanic injections by patients.”

Detailed results on the Phase IIb clinical trial with AM-101 will be published in a scientific journal later this year. Preliminary outcomes from the ongoing third study (Phase II trial), will be released in summer. Following proof of concept, confirmatory Phase III clinical trials are currently under preparation.

About acute inner ear tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or disruptions in its blood supply. It may be short and just transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while tinnitus that is older than one year is considered chronic.

Inner ear tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depres-sion. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method.