Otonomy (OTIC) Says Phase 2 Clinical Trial of OTO-313 in Patients with Tinnitus Demonstrated No Clinically Meaningful Benefit Versus Placebo
- S&P 500, Nasdaq fall as tech shares give up gains
- AI boom could continue to drive S&P 500 higher - Goldman
- Amazon reportedly eyes ad-tier of Prime Video streaming service: WSJ
- Deutsche Bank, Wells Fargo expect US recession to start in Q4 2023
- Cathie Wood buys the dip in Coinbase shares amid SEC crackdown
Get Alerts OTIC Hot Sheet
Overall Analyst Rating:
NEUTRAL ( Up)
Join SI Premium – FREE
Get inside Wall Street with StreetInsider Premium. Claim your 1-week free trial here.
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that the OTO-313 Phase 2 trial in tinnitus demonstrated no clinically meaningful benefit versus placebo for primary and secondary endpoints across all timepoints.
The randomized, double-blind, placebo-controlled Phase 2 trial enrolled 153 patients with persistent, unilateral tinnitus of at least moderate severity. Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (n=77) or placebo (n=76) and followed for 4 months. The primary endpoint was a responder analysis based on the proportion of patients who reported a clinically meaningful improvement, defined as a reduction of 13 points or more in the Tinnitus Functional Index (TFI), from baseline to both Months 1 and 2 following treatment. The trial failed to meet this primary endpoint as well as secondary endpoints for the total study population. Although OTO-313 did show a higher response rate than placebo in a prospectively defined patient subgroup with tinnitus duration of less than 6 months (population studied in Phase 1/2 trial), the overall results do not support further development of OTO-313.
"These results were unexpected with a much higher placebo response than observed in the prior Phase 1/2 study,” said David A. Weber, Ph.D., president and CEO of Otonomy. “In addition to this trial, we have also reviewed preliminary top-line results for the one-month safety evaluation of higher and bilateral dosing of OTO-313 and did not observe a treatment benefit that is convincing in light of the Phase 2 results. Therefore, we must make the difficult decision for all stakeholders including patients and clinicians who were highly supportive of this trial to discontinue further work on OTO-313. We also intend to implement other measures to extend our cash runway.”
The company’s clinical focus shifts to OTO-413 for the treatment of hearing loss. Positive Phase 2a results for OTO-413 were announced in April 2022, which corroborated findings from an earlier Phase 1/2 study. In addition, enrollment is complete for evaluation of higher dosing with top-line results expected in the fourth quarter of 2022.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Biogen (BIIB) on Watch After FDA Posts Briefing Documents for Lecanemab for the Treatment of Alzheimer's Disease
- Micron Technology (MU) Enables Computationally Intensive AI, Data Analytics and Memory-Focused Workloads With High-Capacity, High-Performance RDIMM Memory Solutions
- VistaGen Therapeutics (VTGN) Reports Positive Results from Exploratory Phase 2A Study of PH80 in Women Diagnosed with Menopausal Hot Flashes
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Hot FDA News, Trading Halts
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!