Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced enrollment of the first patient in its pivotal Phase 2b study of OTO-104 for the reduction of vertigo in patients with unilateral Meniere's disease. The company also announced that the U.S. Food and Drug Administration (FDA) has granted OTO-104 Fast Track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This prospective, randomized, double-blind, placebo-controlled Phase 2b study is designed to assess the efficacy and safety of OTO-104 for the treatment of Meniere's disease in a total of 140 patients at approximately 50 centers in the United States and Canada. The primary endpoint is the reduction in vertigo frequency at week 12, measured during the 4-week interval from week 9 through week 12, compared to baseline. Otonomy expects to complete patient enrollment of the trial by mid-2014 and announce top line results during the fourth quarter of 2014.
"The commencement of enrollment marks an important clinical milestone for the advancement of OTO-104 as we expect this trial will serve as one of the two studies required to demonstrate efficacy for approval in the United States," said David A. Weber, Ph.D., president and CEO of Otonomy. "The FDA's Fast Track designation shows that the agency recognizes the potential for this product to address the important unmet medical need in Meniere's disease."
Added Paul R. Lambert, M.D., professor and chair of the department of otolaryngology – head and neck surgery at Medical University of South Carolina, and clinical investigator for the Phase 2b clinical trial, "Unpredictable spontaneous vertigo is life altering and a source of considerable distress for patients with Meniere's disease, and there are currently no FDA-approved drug therapies. This study may bring us closer to providing a safe and effective treatment option for the many patients with this debilitating disorder."
The study will also assess the safety and tolerability of OTO-104, which is a proprietary, sustained-exposure otic formulation of dexamethasone. Upon screening, all subjects will enter into a 4-week observational period for a baseline assessment during which subjects will record their vertigo and tinnitus symptoms via a daily diary. Following the lead-in period, eligible subjects will be randomized 1:1 to a single intratympanic injection of 12 mg OTO-104 or placebo (gel vehicle). Tinnitus will also be assessed as a secondary endpoint in the study.