SAN DIEGO, Dec. 11, 2013 /PRNewswire/ -- Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced dosing of the first patients in its two Phase 3 trials of OTO-201 for the treatment of pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. OTO-201 is Otonomy's proprietary, sustained-exposure otic formulation of the antibiotic ciprofloxacin.
The two identical, prospective, randomized, double-blind, sham-controlled Phase 3 studies are expected to enroll a combined total of approximately 500 subjects, ages 6 months to 12 years old, across 60 trial sites in the United States and Canada. The primary endpoint of the studies is the effectiveness of OTO-201 as measured through day 15 by the cumulative proportion of study treatment failures, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication. Completion of patient enrollment is expected during the second quarter of 2014.
"Following tube placement surgery, we frequently see parents of these very young patients struggle to comply with repeat administration of ear drops which is important to prevent post-operative complications," said pediatric otolaryngologist, Eric A. Mair, M.D., of Charlotte Eye, Ear, Nose & Throat Associates. "The potential to administer a full course of antibiotics with a single dose given during the procedure would be an attractive treatment option for patients, parents and physicians."
Added David A. Weber, Ph.D., president and CEO of Otonomy, "Initiating the two registration studies for OTO-201 is a major step forward for the company, which has worked diligently to advance this program since the successful completion of the Phase 1b trial less than six months ago. We look forward to having top-line data in the middle of next year to continue this rapid pace towards commercialization."
Subjects will receive either OTO-201 or sham injection in both ears during the operation and will be evaluated for the primary endpoint on days 4, 8 and 15 post surgery. A culture of the effusion from each ear will be obtained prior to treatment with OTO-201 or sham injection and at subsequent time points to determine microbiological response. The two Phase 3 studies will also assess the safety and tolerability of OTO-201 in this setting.
Additional information about study protocol and enrollment sites for the study can be found at www.clinicaltrials.gov using the study identifier NCT01949142 or NCT01949155.
OTO-201 is a proprietary, sustained-exposure formulation of the antibiotic ciprofloxacin that has been designed for administration by ear, nose and throat (ENT) specialists to treat a broad range of otic conditions including chronic otitis media. Preclinical studies have demonstrated that a single dose of OTO-201 provides sustained ciprofloxacin drug concentrations in the middle ear that exceed levels observed with twice-daily dosing of antibiotic ear drops for seven days. The lead indication for OTO-201 is intra-operative treatment of middle ear effusion (fluid) in pediatric patients requiring tympanostomy tube placement surgery. The product successfully completed a Phase 1b trial that demonstrated a statistically significant reduction of treatment failure of more than 60 percent relative to the placebo/sham group (p<0.05) and the therapy appeared to be well tolerated. OTO-201 began Phase 3 testing in December 2013.
About Tympanostomy Tube Placement Surgery
Approximately one million tube placement procedures are conducted each year in the United States with the vast majority performed in children suffering from recurrent or persistent otitis media, inflammation or infection of the middle ear. Most patients receiving tubes have middle ear effusion at the time of surgery which significantly increases their risk of post-operative complications including otorrhea (drainage) and tube occlusion. A number of clinical studies have demonstrated that administration of topical antibiotics during and immediately following tube placement surgery significantly reduces this risk. No antibiotic product has been approved by the FDA for this use and current treatment relies on parent compliance with multi-day dosing regimens.
Otonomy is a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the middle and inner ear following a single intratympanic (IT) injection. Otonomy has three product candidates in development. OTO-201 is an antibiotic that is in Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Meniere's disease. OTO-311 is an NMDA antagonist in development as a treatment for tinnitus. For more information please visit: www.otonomy.com.
Stefan Loren, Ph.D.
Robert H. Uhl
SOURCE Otonomy, Inc.