Small cap Auris Medical has been hit hard by the phase 3 failure of its sudden deafness candidate, leading it to halt work on a second late-stage test for the med.
AM-111 was being tested in the HEALOS phase 3 trial in patients with severe to profound sudden deafness. But it failed to hit its primary endpoint of a “statistically significant improvement in hearing from baseline to day 28” compared with a dummy treatment.
As is becoming more frequent, the Swiss biotech dug down into the data and found a subpopulation taking the lower dose of the med 0.4 mg/mL (the second dose was double this) with profound and acute hearing loss showed “clinically and statistically significant improvement.”
Despite failing to hit its marks overall, the company's chairman and CEO Thomas Meyer called 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.”
But these results have proven bad enough to axe another late-stage trial, known as ASSENT and with a “very similar design” to the failed HEALOS.
This comes more than a year after another phase 3 flop, known as TACTT2, which saw its candidate Keyzilen (AM-101) fail to beat out a dummy therapy in treating patients with tinnitus.
Specifically, its treatment could not best placebo in creating statistically significant changes in tinnitus loudness and tinnitus burden. It then went about changing the goalposts of a new test of the drug.