Otonomy Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for hearing loss and tinnitus, is preparing to present the results of a phase 2 clinical trial evaluating its lead drug candidate for tinnitus, OTO-313.
The study, “A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection,” began in March 2021 and completed less than 10 days ago, on June 30, 2022. This phase 2 study enrolled 153 participants across 48 different trial locations.
Ahead of schedule?
As recently as February, this trial was only expected to complete in August 2022. However, now it’s looking like we ought to get some results by August 2022.
The official study record was updated this past Tuesday, July 5, 2022, to reflect the actual completion date: June 30, 2022. That’s over a month early, compared with the anticipated completion date… but likely owing to the fact that Otonomy fully enrolled the trial ahead of schedule too.
Some quick background information, for those of you just learning about OTO-313 for the first time.
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. (Source: Otonomy Inc.)
What’s next for OTO-313?
According to Otonomy’s most recent recent press releases and investor presentations on the subject of OTO-313 and its recently-completed phase 2 study, we can expect the following:
- Results from this phase 2 trial are expected in the second half of 2022, according to a February 2022 press release.
- “OTO-313 Phase 2 Trial: Expect Top-line Results in August”, according to a May 2022 investor presentation.
- As of July 9, 2022, that would mean anywhere between 23 days and 54 days.
When that happens, when those results are shared… Here’s what a best case scenario would lead to:
Assuming the OTO-313 phase 2 study results are favorable — and end up supporting the efficacy endpoint and durability of treatment benefit — Otonomy plans to do the following:
- Hold an End-of-Phase 2 (EOP2) meeting with the FDA by end of 2022.
- Initiate phase 3 clinical program in first half of 2023.
What is an EOP2 meeting, you ask?
EOP2 meetings should be held before phase 3 trials begin, and topics include:
- Determine the safety of proceeding to phase 3
- Evaluate the phase 3 plan and protocols for adequacy and to assess […] safety and effectiveness
- Identify information necessary to support a marketing application
Remember, this is all contingent on positive phase 2 results.
August, here we come…
How to get email updates RE: the upcoming OTO-313 phase 3 trial
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Sign up if you want the earliest tinnitus treatment updates. Simple proof: This article was created and sent to email subscribers on July 9, 2022. It describes the completion of a phase 2 trial of a much-anticipated tinnitus drug, OTO-313. Meanwhile, there has not yet been any official announcement or press release from Otonomy yet the company behind the drug. (When they do publish one, we will, of course, share that too.)