Otonomy, Inc. has announced topline results from its Phase IIb trial evaluating OTO-104 in patients with unilateral Ménière's disease. The primary endpoint of the trial was reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period. In the topline analysis, OTO-104 demonstrated a 61% reduction from baseline in vertigo frequency in Month 3 vs. 43% for placebo with a p value of 0.067, which narrowly missed achieving statistical significance. In addition to Month 3, a similar positive trend was also observed during Month 2 following treatment.
"While the trial narrowly missed achieving statistical significance on the primary endpoint, we believe the clear efficacy trends observed along with the multiple secondary endpoints where statistical significance was achieved provide a solid basis to move OTO-104 forward into Phase III testing," said David A. Weber, president and CEO of Otonomy. "We plan to request an End-of-Phase II meeting with the FDA and intend to initiate two parallel Phase III trials in Ménière's disease with the first beginning by the end of 2015."
OTO-104 was well tolerated in the study and no drug-related serious adverse events were observed. Persistent perforations of the tympanic membrane at the end of Month 4 were observed in 2.6% of patients treated with OTO-104 which is consistent with the findings from the OTO-104 Phase 1b trial as well as published results for trials utilizing intratympanic injection of steroid solutions.
