Otonomy begins OTO-313 Phase 1/2 clinical study for tinnitus patients

By Mateen Dalal

Results from the trial are expected in the first half of 2020 and the information would be used to design and plan any further clinical development

Biopharmaceutical firm Otonomy, Inc., has reportedly initiated the Phase 1/2 clinical trial of OTO-313 in patients suffering from tinnitus. OTO-313, apparently, is a sustained-exposure formulation of gacyclidine, the NMDA receptor antagonist.

The Phase 1/2 study, which is double-blind, randomized and placebo-controlled, would consist of an initial safety cohort to be followed by an exploratory study of efficacy, enrolling nearly 50 patients having subjective tinnitus, Otonomy confirmed.

Otologist and Neurotologist at the Ear Medical Group in San Antonio and a University of Texas Health Science Center clinical professor, Susan Marenda King, M.D., said that tinnitus has become a common issue that affects millions of people.

The disorder can lead to constant annoyance which negatively impacts the quality of life of a person, by disrupting their concentration and the ability to enjoy leisurely activities or obtain sufficient sleep, Dr. Susan added. She also mentioned that presently, there is no drug therapy for treating these patients.

President and CEO of Otonomy, David A. Weber, Ph.D., stated that this trial of OTO-313 would be evaluating its potential as a therapy for patients with tinnitus. He informed that results from the trial are expected in the first half of 2020 and the information would be used to design and plan any further clinical development.

Supposedly, a Phase 1 clinical safety trial had been completed earlier for an initial formulation of gacyclidine, where no safety concerns were observed. OTO-313 is considered as an enhanced formulation of gacyclidine and a single intratympanic injection is to be used for its administration.

For the uninitiated, tinnitus is the medical term used when a person experiences the perception of noise even when there is no sound. Patients often described it as a ringing in the ear, but it can also sound like clicking, roaring, buzzing or hissing. Estimates show that nearly 10% of U.S. adults are living with this condition.