Auris Medical has lurched from a failed late-stage study of its experimental tinnitus drug last year to a Phase III flop for its hearing loss therapy. And once again, it’s claiming that a changeup in trial design could fix everything.
The Swiss biotech $EARS tested two doses of AM-111 in patients with severe to profound sudden deafness, and both failed to achieve statistically significant improvements for the people who took the drug compared to a placebo.
Auris immediately shifted to a post hoc analysis — not the most popular route for developers — of one group of patients “with profound acute hearing loss,” and discovered a positive change in the low dose arm. The biotech, though, says it is scrapping another Phase III that has a similar design with virtually no chance of success.
Auris’ post hoc work wasn’t convincing enough for shareholders, who greeted the second round of bad news with another slap at the stock price, now down 41% in pre-market trading as Auris shares drill a deeper hole in penny stock territory.
The latest setback follows the Phase III failure of Auris’ tinnitus therapy, which they also responded to with a pitch that it could fix the data with a changeup in the primary endpoints.
Auris CEO Thomas Meyer said that the latest trial was a “major milestone” for the company.
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.
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