Late in August, shares of Otonomy, Inc.(NASDAQ:OTIC) took a drubbing after missing the primary endpoint and key vertigo secondary endpoints in a late-stage trial, coined AVERTS-1, of Otividex in patients with the rare, balance-affecting inner ear disorder Ménière’s disease.
Shares sank from over $21 each to a low yesterday at $2.80. On Thursday, shares have reversed to recoup part of the steep losses on positive data from another phase 3 trial for Ménière’s disease.
In the AVERTS-2 study of Otividex, the primary endpoint lowering the count of definitive vertigo days (DVDs) was achieved. The study, which enrolled 174 patients across six countries in Europe, showed a single injection of Otividex into the inner ear was able to reduce the number of DVDs within three months.
At baseline, patients averaged 9 DVDs in the prior four-week period. Following therapy, Otividex reduced DVDs by an average of 6.2 days, compared to a drop of 2.5 days for patients in the placebo group, a difference considered statistically significant.
The kicker here is that the protocol for the AVERTS-2 study overseas was the same as that of the AVERTS-1 study in the U.S. that whiffed on endpoints, meaning there will need to be some data culling to try and explain what happened.
The company said that the latest results were consistent with a successfully completed phase 2b trial.
In the meantime, the results have breathed life back into the stock, as Otonomy plans to meet with the U.S. Food and Drug Administration in Q1 2018 to discuss a new drug application for Otividex. About one hour into the trading session, shares of OTIC have skyrocketed 106.3% to $5.78.
Separately, Otonomy released results from the latest quarter, which included $300,000 in sales of Otiprio, the San Diego-based company's only marketed drug. Otonomy ended the quarter with $134.3 million in cash, cash equivalents and short-term investments, which was actually higher than the company's market capitalization coming into today's trading.
