Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus

• OTO-313 demonstrated a higher proportion of responders than placebo
  
• Given clear signal in this proof of concept study, Otonomy plans to advance OTO-313 to full Phase 2 development in tinnitus
• OTO-313 was well-tolerated with lower incidence of adverse events than placebo group
• Management will review results during conference call today at 4:30 p.m. ET

SAN DIEGO, July 06, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity. The exploratory efficacy cohort of the trial included 31 evaluable patients randomized to a single intratympanic injection of OTO-313 or placebo (1:1 randomization) and then followed for eight weeks. Patients reported the severity of their tinnitus symptoms using the Tinnitus Functional Index (TFI), a clinically-validated instrument, and by the daily reporting of their tinnitus loudness and annoyance. The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile. Given these results, Otonomy intends to advance OTO-313 into full Phase 2 development which may include evaluation of a higher dose and/or retreatment with OTO-313.

Top-line results for the Phase 1/2 trial were as follows:

• 43% of OTO-313 patients were responders at both Day 29 and Day 57 compared to 13% of placebo patients. A responder is a patient whose TFI score decreases by 13-points or more from their baseline score, a change considered clinically meaningful based on the TFI instrument validation.
   
• For patients who were responders at both Day 29 and Day 57, OTO-313 demonstrated a higher responder rate than placebo at all TFI improvement levels considered clinically meaningful (TFI reduction ≥ 13, 15, 20, 25, and 30 points). The difference in responder rate between OTO-313 and placebo was statistically significant on post hoc analysis (p-value < 0.05) for TFI reductions ≥ 13, 15, and 20 points.
   
• OTO-313 patients who were responders at both Day 29 and Day 57 reported improvements in both tinnitus loudness and annoyance levels based on daily diaries and also reported improvement in the Patient Global Impression of Change (PGIC), a general assessment of tinnitus status. There was a very strong relationship demonstrated between the improvement in TFI score reported by these OTO-313 responders and their improvement in tinnitus loudness and annoyance levels as well as PGIC based on the calculated correlation coefficients of ≥ 0.8 for these endpoints.