Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced the successful completion of a phase 2 clinical trial that evaluated a single administration of Otiprio (ciprofloxacin otic suspension) for the treatment of paediatric patients with acute otitis media with tympanostomy tubes (AOMT).
The phase 2 trial was designed to evaluate the safety and tolerability of two dose levels of Otiprio, 6 mg (0.1 ml) and 12 mg (0.2 ml), administered in paediatric patients with AOMT and to determine the most appropriate dose for further development in this indication. The trial demonstrated that both Otiprio doses were well-tolerated, achieved higher and statistically significant (p<0.05) clinical cure rates over sham (no treatment), with the highest clinical cure rate observed in the 12 mg dose group.
Additional results from this trial will be presented at the Otonomy Investor and Analyst Day on October 7 and will be presented at an upcoming medical conference.
“This study builds on the prior phase 2 trial, which established the feasibility of administering Otiprio in an awake child in the physician office setting, by demonstrating that the preferred dose for further development in AOMT is 12 mg,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, we believe that achieving statistical significance in the clinical cure rate versus sham, with a relatively small number of subjects in this study, establishes a favourable benchmark for sizing a successful registration program for Otiprio in AOMT. We intend to meet with the FDA to discuss the requirements for such a program following our completion of the ongoing phase 3 registration trial in acute otitis externa, the first label expansion indication for Otiprio."
The one-month, prospective, randomized, sham-controlled, blinded phase 2 clinical trial enrolled 95 paediatric patients with unilateral or bilateral AOMT at 12 centres in the United States. The trial was designed to evaluate the safety, tolerability, and comparative clinical activity of two dose levels of Otiprio, 6 mg (0.1 ml) and 12 mg (0.2 ml), when administered as a single treatment in the physician’s office. Clinical activity was primarily assessed at day 15 based on clinical cure rate defined as resolution of otorrhea determined by the physician through an otoscopic examination.
Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of paediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two phase 3 trials, a single intraoperative administration of Otiprio demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).