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.
Source: Otomony
"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.
Source: Otomony
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