Otonomy Announces Positive Phase 1b Results for OTO-201 in Pediatric Patients Undergoing Ear Tube Placement Surgery Single administration of sustained-release antibiotic demonstrated clinically meaningful reduction in post-operative treatment failure
SAN DIEGO, Aug. 20, 2013 /PRNewswire/ -- Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced positive results from a Phase 1b study of OTO-201 in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. OTO-201 is Otonomy's proprietary, sustained-release otic formulation of ciprofloxacin. Study results showed that OTO-201 reduced the risk of treatment failure, as measured by the occurrence of post-operative otorrhea (drainage) or use of rescue antibiotics, by more than 60% versus control. OTO-201 was well-tolerated at both doses tested. Otonomy plans to discuss these study findings and next steps for clinical development of OTO-201 at an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
"We are pleased with the strong treatment effect seen in this study which achieved statistical significance with respect to the cumulative proportion of treatment failures for both OTO-201 dose groups versus control at two weeks following surgery," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. "These results support the clinical utility of OTO-201 given as a single dose at the time of surgery to improve outcomes and eliminate the requirement for post-operative treatment by parents."
This randomized, prospective, multi-center, double blind, placebo- and sham- controlled Phase 1b clinical trial enrolled 83 pediatric patients between 6 months and 12 years of age who required TTP surgery. OTO-201 was administered as a single intra-operative treatment for patients with bilateral middle ear effusion on the day of surgery. Two dosage strengths of OTO-201 (2% and 6%) were tested in the trial. Treatment failure, defined as the presence of otorrhea or use of rescue medication, over the 15-day cumulative period following surgery was the primary endpoint. Both OTO-201 active treatment arms showed a reduction of treatment failure of more than 60% relative to the placebo/sham group (p<0.05). OTO-201, at both doses tested, appeared to be well-tolerated in the trial. Otonomy plans to present these results at an appropriate medical meeting in the future.
OTO-201 is a proprietary sustained-release 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. 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 has successfully completed a Phase 1b trial and is expected to enter late-stage testing by the end of 2013.
About Tympanostomy Tube Placement Surgery
Approximately one million tube placement procedures are conducted each year in the U.S. 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 is a sustained-release formulation developed for optimal delivery of drugs to the middle and inner ear with a single intratympanic (IT) injection. Otonomy has two product candidates in clinical development. OTO-104 is a steroid that has completed a Phase 1b clinical trial in Meniere's disease patients. OTO-201 is an antibiotic that has recently completed a Phase 1b clinical trial in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. Otonomy is advancing both OTO-104 and OTO-201 into late-stage clinical trials. Additional product candidates are expected to target tinnitus and chronic forms of hearing loss.
For more information please visit: www.otonomy.com.
Stefan Loren, Ph.D.
Robert H. Uhl
SOURCE Otonomy, Inc.