Auris Medical, a small cap biotech company dropped after phase 3 failures of its sudden deafness drug candidate, resulting it to stop work on a second late-stage test for the drug. AM-111 was being tested in the HEALOS phase 3 trial in patients with severe to profound sudden deafness. Despite it failing to reach its primary endpoint of a “statistically significant improvement in hearing from baseline to day 28” compared with a placebo medicine.
The Swiss-based biotech dove into the data and discovered a subpopulation taking the lower dose of the med 0.4 mg/mL, while the second dose was double this. It resulted in profound and acute hearing loss displayed “clinically and statistically significant improvement.”
Regardless of it failing to hit its marks overall, the company’s chairman and CEO Thomas Meyer stated this a “major milestone for Auris,” adding: “Although the trial did not meet our expectations for the primary efficacy endpoint in the overall study population, we are very pleased to see the clinically and statistically significant treatment effect in the profound hearing loss subpopulation.”
“Considering the high unmet medical need, we look forward to discussing with regulatory agencies the next steps on our path to bringing AM-111 to patients.”
Though these results have proven bad enough to cut another late-stage trial, known as ASSENT and with a “very similar design” to HEALOS. This comes on the heels of another phase 3 flop, known as TACTT2, which reported its candidate Keyzilen (AM-101) fail to defeat a dummy therapy in treating patients with tinnitus.
Precisely, its treatment could not beat its placebo in creating statistically significant adjustments in tinnitus loudness and tinnitus burden. It then went about adjusting the endpoints of a new test of the drug.