Otonomy, a clinical stage biopharmaceutical company developing therapeutics for diseases and disorders of the inner and middle ear, has revealed positive data from a phase Ib study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.
Study results showed OTO-104 to be well-tolerated at both doses tested when delivered via a single intratympanic (IT) injection. Additionally, while not powered to demonstrate statistically significant clinical activity, data from the trial showed that patients receiving OTO-104 experienced greater reductions in vertigo frequency and tinnitus compared to patients receiving placebo.
A total of 44 patients with unilateral Meniere's disease were enrolled in this prospective, randomized, double-blind, placebo-controlled multicenter study. Patients participated in a one-month baseline period to characterize disease status, followed by randomization to receive a single IT injection of OTO-104 (3mg or 12mg) or placebo. Patients were monitored over a three-month observation period following injection.