Otonomy, Inc (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, announced the initiation of a Phase 1/2 clinical trial of OTO-313, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in patients with tinnitus. The randomized, double-blind, placebo-controlled Phase 1/2 study will include an initial safety cohort followed by an exploratory efficacy study that will enroll approximately 50 patients with subjective tinnitus.
“Tinnitus is a common problem affecting millions of people,” said Susan Marenda King, MD, neurotologist and otologist at the Ear Medical Group in San Antonio, and clinical professor at the University of Texas Health Science Center. “The constant annoyance of tinnitus can negatively impact a patient’s quality of life by disrupting their ability to concentrate, enjoy leisure activities, and obtain restful sleep. Unfortunately, we currently have no drug therapy to offer these patients. I am excited about the potential of OTO-313 and pleased to be part of the Phase 1/2 clinical trial.”
“We are excited to advance the clinical development of OTO-313 by initiating this trial, which will evaluate the therapeutic potential of OTO-313 in patients with tinnitus,” said David A. Weber, PhD, President and CEO of Otonomy. “We expect results from this study in the first half of 2020 and will use the information to inform the design and plan for further clinical development.”