SAN DIEGO, CALIFORNIA — Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, has announced the completion of patient enrollment in the Phase 2 clinical trial of OTO-313 in tinnitus.
The randomized, double-blind, placebo-controlled trial enrolled 153 patients with persistent, unilateral tinnitus of at least moderate severity (target enrollment was 140 patients).
Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (0.32 mg) or placebo and are being followed for 4 months. The primary endpoint is the same as reported for the successful Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in the Tinnitus Functional Index (TFI) from baseline to Months 1 and 2, following treatment.
Top-line results for all timepoints are expected to be available in mid-2022.
“We are excited to fully enroll this trial ahead of schedule, which we believe is an indication of the strong unmet medical need in the treatment of tinnitus. Tinnitus negatively impacts millions of people by disrupting their ability to sleep, concentrate at work, and enjoy leisure activities. This often leads to anxiety and depression. Unfortunately, there are no approved drug treatments for tinnitus and current therapy focuses on coping and masking mechanisms. We thank the patients and investigators who enabled us to achieve this important milestone for the OTO-313 program.”
–David A. Weber, Ph.D., President and CEO of Otonomy
Tinnitus is the medical term for the perception of noise when there is no sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Tinnitus is often caused by cochlear injury due to excessive noise, physical trauma, persistent ear infection or exposure to an ototoxic agent, leading to over-activation of auditory nerve fibers and the perception of noise in the absence of an external stimulus. Approximately 10 percent of U.S. adults suffer from the condition, which can severely impact daily activities and result in anxiety and depression. Tinnitus also accounts for the most prevalent service-connected disability among veterans with an estimated cost exceeding $2 billion. There are currently no FDA approved drug treatments for tinnitus.
OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine. Otonomy believes that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea. OTO-313 utilizes a novel, patent-protected formulation technology to provide several weeks of gacyclidine drug exposure in the inner ear following a single intratympanic injection. A Phase 1/2 trial of OTO-313 in patients with unilateral tinnitus of at least moderate severity demonstrated a positive clinical response for OTO-313 using the Tinnitus Functional Index (TFI) that was correlated with improvements in tinnitus loudness, tinnitus annoyance and patient global impression of change measures. In addition to the ongoing Phase 2 trial, Otonomy is initiating a 1-month safety study for bilateral and higher (0.64 mg) dosing of OTO-313 with results expected in the second half of 2022. Together, these clinical data are expected to support an End-of-Phase 2 meeting with the FDA and inform the design of the OTO-313 Phase 3 clinical program planned to start in the first half of 2023.
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs with a focus on hearing loss and tinnitus. For additional information please visit www.otonomy.com.