Clinical trial confirms safety and efficacy trends for Auris Medical’s AM-101

The randomized, placebo-controlled, double-blind study of Auris Medical's AM-101 was conducted in the USA, Belgium, Germany and Poland. It enrolled patients suffering from tinnitus following traumatic injury to the cochlea (acute noise trauma, inner ear barotrauma, middle ear surgery) or otitis media up to 3 months after tinnitus onset. A total of 85 patients were randomized to receive AM-101.

As in the previous studies with AM-101, most adverse events were mild or moderate in intensity and represented transient local effects of the injection procedure.

In addition, the TACTT1 trial showed a clear trend for superior improvement in AM-101 treated study participants over placebo groups with regards to subjective tinnitus loudness, annoyance, sleep difficulties, tinnitus handicap/impact and tinnitus severity. Although the study was not powered to demonstrate statistical significance between treatment groups, the difference between active and placebo groups was significant for several efficacy outcomes.

“We are very pleased with the positive outcomes from this second phase II study with AM-101,” commented Thomas Meyer, Auris Medical’s founder and Managing Director. “They corroborate and complement the promising results from our previous trials and provide strong support for our planned phase III confirmatory studies.” He added: “The almost 900 intratympanic injections that have been performed in our clinical development programme so far helped us gain valuable insights into the nature and size of treatment responses at different concentrations, under different dose regimens and for tinnitus with different origins.”

These insights together with outcomes from discussions with regulatory agencies will be reflected in the design for the phase III trials which are expected to start later this year.