SAN DIEGO, CALIFORNIA — Otonomy has announced the initiation of a Phase 1/2 clinical trial of OTO-313 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.
OTO-313 is said to be a “sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine”. According to the company, a Phase 1 clinical safety trial was previously completed for an initial formulation of gacyclidine, with no safety concerns observed.
OTO-313 is an improved formulation of gacyclidine that is intended to be administered via a single intratympanic injection.
“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. 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.”
–David A. Weber, PhD, Otonomy President and CEO
“Tinnitus is a common problem affecting millions of people,” said Susan Marenda King, M.D., 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.”
According to the company’s announcement, the results from the study are expected in the first half of 2020.