San Diego — Otonomy Inc has announced positive new results from a Phase 1b study of OTO-104 intratympanic (IT) injection in patients with Ménière’s disease. The data showed that patients treated with OTO-104 experienced clinically meaningful reductions in vertigo frequency and improvements in tinnitus as compared to placebo.
Researchers presented findings showing clinically meaningful reductions in vertigo frequency at 3 months with the 12 mg OTO-104 dose as compared to placebo. Prior to treatment, patients in both the 12 mg OTO-104 and placebo groups experienced an average of 8 days with definitive vertigo episodes during a baseline period of 1 month.
Following a single IT injection, patients in the 12 mg OTO-104 group experienced a month-over-month reduction in vertigo frequency throughout the 3-month follow up period, and achieved an approximate 6-day reduction in the number of definitive vertigo days in the third month versus baseline.
When compared to placebo, at 3 months following treatment, the 12 mg study group experienced a 70% greater reduction from baseline in the number of days with definitive vertigo episodes. However, there was no clinically meaningful difference in vertigo frequency between the 3 mg OTO-104 and placebo groups at 3 months following treatment.
Additionally, the presented study data demonstrated that both the 3 mg and 12 mg OTO-104 doses were associated with improvement in tinnitus as measured by the Tinnitus Handicap Inventory (THI-25).
THI is a clinically validated patient-reported measure that can be used to quantify the impact of tinnitus on activities of daily living. Both OTO-104 doses resulted in reductions in THI Total Score from baseline as early as 1 month following treatment.
Furthermore, these THI Total Scores continued to decrease throughout the entire 3-month follow-up period, suggesting continued improvement in tinnitus symptoms experienced by patients treated with OTO-104. By contrast, the study’s placebo group demonstrated little change in THI Total Score from baseline during the 3-month follow-up period.
As previously reported, results from this study showed OTO-104 to be safe and well-tolerated at both doses tested when delivered via a single IT injection.
The company says that it is important to note that despite demonstrating meaningful
clinical activity in the areas of vertigo and tinnitus, this study was not powered to demonstrate statistical significance. Based on these study results, Otonomy will initiate a Phase 2 clinical trial of OTO-104 in Ménière’s disease during the fourth quarter of 2011.
A total of 44 patients with unilateral Ménière’s disease were enrolled in this prospective, randomized, double-blind, placebo-controlled multicenter study. Patients participated in a 1-month baseline period to characterize disease status, followed by randomization to receive a single IT injection of OTO-104 (3 mg or 12 mg) or placebo.
The company says that its upcoming Phase 2 study will include a much greater number of patients and delve more into OTO-104’s clinical efficacy for Ménière’s disease.
SOURCE: Otonomy Inc