News & Events
Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus
- Phase 2 study design based on successful Phase 1/2 trial including use of Tinnitus Functional Index (TFI) responder analysis for primary efficacy endpoint
- Patient enrollment criteria refined to enrich study population
- Top-line results expected in mid-2022
"Tinnitus is a common problem that 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 that can be quite severe, as sadly reported in a recent case of a prominent post-COVID patient experiencing unrelenting tinnitus,” said
The Phase 2 trial will be conducted at approximately 50 clinical sites in the
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
OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. We believe 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 and their connections. 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. In 2020, we reported positive results from a Phase 1/2 trial of OTO-313 in patients with unilateral tinnitus of at least moderate severity. This trial 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.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of
Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: delays and disruption resulting from the COVID-19 pandemic and governmental and site responses to the pandemic, including current and future impacts to Otonomy’s operations, the manufacturing of its product candidates, the progression of its current clinical trials, and patient conduct and compliance; Otonomy’s ability to accurately forecast financial results; Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment, conduct and compliance in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could impact the performance under or give rise to the termination of Otonomy’s collaboration, co-promotion or license agreements, or that could impact Otonomy’s ability to repay or comply with the terms of the loan provided by
Source: Otonomy, Inc.