the disease . Patient enrollment in a pivotal mid-stage clinical trial should be completed in another month or so, with top line results expected by the end of the year.
Soon after taking over, Weber changed the lineup in Otonomy’s drug pipeline to make an antibiotic designated as OTO-201 the company’s lead drug candidate. OTO-201 is formulation of the antibiotic ciprofloxacin in a gel that is intended to treat various types of inflammation of the middle ear in children who are 6 months to 5 years old, and who undergo tympanostomy tube placement surgery. Instead of asking parents or caregivers to administer antibiotic eardrops for seven days after a surgeon has inserted shunts, Weber says the surgeon would administer the long-lasting antibiotic gel (which would last seven days or longer) into the middle ear during the procedure.
OTO-201 was in pre-clinical development when Weber took over in 2010, but he said, “OTO-201 ultimately took the lead because it was a much more straightforward development process.”
The company is now close to enrolling 500 patients in two late-stage clinical trials in the United States and Canada that are running simultaneously. Top line results could be available as early as this fall, which should enable Otonomy to submit a new drug application by the first quarter of 2015, Weber said.
Meanwhile, Otomony has added a third drug candidate, OTO-311, to its pipeline. This drug is a new gel-based treatment for tinnitus—the sensation of “ringing” in the ears.
Weber said Otonomy plans to introduce its drugs in the North American market, as well as some countries in Europe. But he adds, “There are places in the world [such as Asia], where we think it makes sense to work with a strategic partner.”
