Looks like the recent failure of AM-101 in the first Phase III trial has the potential to affect OTO-311. They have been following AM-101 and will wait on the results of TACTT 3 before making a decision about whether to move forward or not with OTO-311. This is from an interview with the CEO of Otonomy:
"Does this Auris news impact your plans at Otonomy?
With tinnitus, our program is in phase 1. Our strategy was to follow Auris — utilize their data to our advantage, and use their investor dollars to do our proof of concept work for that program. We didn't feel we needed to rush out into phase 2. Instead, we were planning to evaluate their data and determine how to move forward with our OTO-311 program. That's still the plan. We're waiting on their second phase 3 trial, see their outcome, and then we will make a determination about our program.
Is the tinnitus drug you're developing is similar to Auris's compound, then?
Our drug has the same target — we both are NMDA receptor antagonists. Our drug's different, though. It's more potent on a molecule-to-molecule basis for the target receptor. It also has a more specific target profile. But we have the same general mechanism of action, which is why we're watching their data.
Clearly there's a relationship, because it's the same target receptor we're going after, so if the data would indicate there's absolutely no effect, then we'll have to evaluate our options. There are a lot of possibilities around what went wrong, so that's where we need to wait, and evaluate the results.
So what do you think went awry with Auris's clinical trial?
We don't know yet whether or not the failure of their trial was based on issues with the endpoints, issues with the patient population, with their clinical trial design, with their dosage… any number of things could have impacted the outcome of the study."
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