Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, announced positive data from a Phase 1b study of the company’s lead product candidate, OTO-104, in patients with Ménière’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. Otonomy plans to discuss these study findings with the United States Food and Drug Administration (FDA) and initiate a Phase 2 clinical trial of OTO-104 in Ménière’s disease by the end of 2011.
“OTO-104 was well-tolerated at both doses and we experienced no technical issues with administration of the sustained release formulation via IT injection,” stated Paul R. Lambert, M.D., professor and chair of the department of otolaryngology – head and neck surgery, Medical University of South Carolina, and the study’s lead investigator. “Furthermore, the improvements in vertigo and tinnitus observed in this study support the potential benefit of OTO-104 in the treatment of patients with Ménière’s disease and suggest that further evaluation in this patient population is warranted.”
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 one-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. Patients were monitored over a three-month observation period following injection. The study’s primary objective was the evaluation of the safety and tolerability of OTO-104 when administered via a single IT injection. Additionally, the study evaluated various indicators of OTO-104 clinical activity including changes in vertigo, tinnitus, hearing function and patient quality of life.
“We are excited by the results from our first clinical trial since they validate the potential of our novel sustained release therapeutic approach and bolster our plan to develop a portfolio of products to treat a broad range of inner and middle ear disorders,” said David A. Weber, Ph.D., president and chief executive officer of Otonomy. “We look forward to discussing these encouraging clinical results with the FDA and advancing towards our goal of delivering an approved drug treatment option for patients suffering from the debilitating symptoms of Ménière’s disease.”
Date: April 28, 2011
Source: Otonomy, Inc.