I went down a bit of a rabbit hole and am now warmer on that idea, though I still think it's best to keep tinnitus out of the trial. If they wanted to check for that it would make more sense to do a separate Phase 1/2 study that focused just on that. If the trials aren't focused there will be problems like what was seen in the FX-322 Phase 2a trial.
Sorry, I forgot to quote that part of your last post, but I meant to say I absolutely agree with you on that! At the end of the day we all want the trial to succeed, and I share your sentiment that keeping tinnitus out of it gives them the best shot.
IIRC, musicians, even those who use hearing protection, tend to have tinnitus simply due to their regular exposure to loud music. So it's probable they just wrote them off as a whole to avoid any problems.
Yeah, reading over the inclusion/exclusion criteria again, I think you're right. Maybe this is another layer of protection against people lying about their tinnitus to enter the trial. Now that I think about it, musicians are uniquely positioned as a profession that 1) is constantly exposed to loud sounds and 2) almost never wears hearing protection. In other professions, hearing protection is taken much more seriously, especially in an industrial setting. Obviously not every musician has tinnitus, but it's probably easier and less risky to not let any musicians in altogether.
Well, they should have excluded more professions if they wanted to be really precise to who they enroll, as there are industries way more noisy (construction, waiters in clubs etc etc) and we kinda know that earmuffs, earplugs etc don't give the protection they advertise.
They're running two mini-trials of 12 people each (8 get the drug, 4 get placebo). One is using 2.5 times the dose of OTO-413, and the other is using 5 times the dose of OTO-413 (compared to the Phase 2a trial).
At some point later (not sure), they announced the 5x dosing. So that must mean the 2.5x dosing was deemed safe. It's unclear to me if they know the results from the 2.5x trial. In addition to higher dosing, they're also considering giving a second shot (this was discussed prior to the two high dose trials). They're most likely looking for ways to boost the efficacy signal.
Is it possible there's an NDA or similar agreement preventing people from discussing their experience(s)?
Possibility, though the OTO-413 Phase 1/2 or Phase 2a studies are done with and the data is out. I would assume people in those studies could talk about it, though then again, I don't know what the rules are.
I can't find the two mini-trials on clinicaltrials.gov, do you know if they are listed?
I don't. I've searched before and come up empty handed. Otonomy did say the mini trials were exactly the same except for the higher dose. I'm not sure if they're not required to list them because the trial is so small, or if they can do the trial under their existing one. Their current clinical trial page is clearly their Phase 1/2 and Phase 2a trials combined (side note: Otonomy originally referred to "Phase 2a" as an extended Phase 1/2 - I'm guessing they changed the verbiage to better separate out the data).
I've learned from the OTO-313 trial not to be optimistic.
OTO-313 was tested in a more subjective way. Which probably allowed for more subject influence. OTO-413 uses word in sound testing which is more objective. It can still crash and burn but unlikely due to the placebo effect.
Didn't we accuse the FX-322 participants of lying in the WIN tests to get into the trial?
Frequency Therapeutics released evidence of suppressed word recognition scores used by patients to gain acceptance into the FX-322 Phase 2A. Which resulted in really abnormal measurements in the placebo group (and drug group). They remedied that with an elongated lead-in period with additional testing gates; which in practice, reduces the likelihood of a patient faking their way into the test. Otonomy already has a similar lead-in for OTO-413. It doesn't sound as controlled as FX-322 Phase 2B, but should reduce unexpected variability with the placebo group.
I understand how you can feel like that but it makes no logical sense. Other treatments are completely different to previous ones that have failed.
Definitely a bit sad and not terribly encouraging, but I suppose this is a necessary step given their current condition.
I hope they have enough cash now. Very bad timing with how the Fed is going through a tightening cycle right now too. They are burning cash way too quickly.
Fed rate hikes have little to do with their cash on hand. Inflation will cause them to burn more quickly in the short term. And frankly, there is no long term for Otonomy if their trials don't succeed.
In that department OTO-413 has a chance, but without its success Otonomy is likely sunk.
Hopefully the next results are good. They need some good signals quick.
This is what's so maddening to me, given we just saw this happen with FX-322. I guess it was maybe too late as Otonomy had already begun their trial design but I can't help but feel like they shot themselves in the foot if the placebo group is actually what brought them down. (Perhaps it wasn't - someone please correct me).
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