More than three years after it was raised from the dead, Otonomy’s lead drug appears headed to the scrap heap for good.
The drug, Otividex, failed to beat placebo at reducing definitive vertigo days for the intent-to-treat population of patients with Ménière’s disease. The p-value, at 0.312, was a far cry from statistical significance.
Despite definitive flops in earlier trials, execs had insisted they had a shot after a second Phase III — which they had originally said they would drop — apparently backed up their belief that they could mine positive data if they focused on the average number of vertigo days at month 3. And that’s not the only tweak they would make to the trial: Back in July, they went to the FDA with a revised statistical analysis plan using a “negative binomial model.”
It didn’t help. The trial enrolled 148 patients who have Ménière’s disease — a condition of the inner ear — and there’s no discernible difference.
Even though the analysis did achieve statistical significance for the smaller per protocol population or using a different model, Otonomy admits there was no more silver lining to hang onto — not that it stops president and CEO David Weber from dreaming about a bright future.
“Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss,” he said, pointing to clinical readouts anticipated in mid-2022.
Investors have lost their patience, though, sending the San Diego biotech’s stock $OTIC down 45.64% to $2.93.