Otonomy OTO-413 — Treatment of Hidden Hearing Loss

We're finally here after a long wait! Hope to hear some good news after Pipeline Therapeutics' let down.

 

The 0% and 10% results for the placebos are the most encouraging.

By increasing the dose, as they intend to do, the results may improve further still.

This is absolutely NOT bad news for tinnitus sufferers.

 

It's big for the company as a failed trial sinks them, I would think. Who knows but they tend to deliver results on time, rain or shine.

Maybe something this week.

 

If OTO-413 has a positive outcome in their higher dose Phase 2a trial, have they stated if the next phase will be their pivotal phase?

 

They will do Phase 2 again next year. This is because the current Phase 2 is for safety as they are using a higher dose.

 

That’s a shame. It seems to be more effective than FX-322 from the results from their current clinical trials, but I do believe you need both to fix both hair cells and synapses.

I hope that the next trial they do ends up being the pivotal phase once positive results come out for their current clinical trial.

 

New synapses are made in the brain all the time. Even taking some simple supplements or nootropics greatly aid in creating new synapses.

 

OTO-413 failed at a higher dose.

Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss

 

Looks like this could be the end for Otonomy... so disappointing and depressing.

 

Yup, just read it. Yeah, I think it’s safe to say being pessimistic about hearing regeneration is pretty realistic. Probably won’t happen for decades.

Hopefully Dr. Shore device comes out and helps some of you guys with really severe tinnitus and maybe Ebselen can help us all.

Everything else is starting to fail and it’s really making me realize I’ll be living in a room with severe noxacusis the rest of my life. Such a scary reality.

Not sure what Otonomy is doing with their trials but they need to step it up and get smarter. They probably lost most of their investors at this point.

 

Are we doomed?

 

I wonder how they plan to realise value from OTO-413, maybe they want to sell the rights to someone else.

Quite disappointing still. This one did look promising.

 

Share price is down -60% on this news and down -95% since just before the news of OTO-313 failing.

I've been thinking about this recently about myself and could be possible but I do think we will have something good at least in our lifetime.

Sounds to me like they want to either try and get funding to trial OTO-413 again or maybe just to sell it outright to someone.

 

I'm looking at the mechanism of action behind OTO-413, which got me wondering: why did Otonomy think that regenerating synapses could help with recovery from hearing loss, with nothing done to regenerate broken/dead hair cells? Seems pointless to me (keep in mind I have a limited understanding of how the inner ear works).

Maybe their technology could be combined with Frequency Therapeutics'? This is just wishful thinking on my part, I don't expect anything like this to happen.

 

OMG. I simply don't know what to write here. Words can't express my agony.

I wish that they would have performed ECoG tests before and after for the participants, just to see those results. I guess I'll pray for synaptic regeneration naturally since that is a hot topic about whether it actually occurs after noise trauma.

 

Like others say... don’t get your hopes up.

 

Wonder if the higher doses overdid it like the multi-dose FX-322. Anyways.

 

It's believed that they contribute to the ability to hear clearly in noise. There are multiple synapses per hair cell, and they die off much sooner than hair cells. Having trouble hearing in noise is a chief complaint for people as they get older.

With this news my hopes for this drug have pretty much gone down the tubes. I have a hard time believing that a higher dose shouldn't work - wouldn't they have seen that problem in their rodent studies?

Hopefully Frequency Therapeutics can pull a rabbit out of their hat with FX-345.

 

Sorry to hear about this latest failure. How the Board can't get rid of Weber after failure after failure is beyond me. He gets paid millions of dollars for producing absolutely nothing.

 

They did mention this in their statement. It could work a lot better with lower doses.

 

I am ready to end it all at this point

 

Which ones help?

 

Hope is all some of us have. I say don't listen to what others say if that's all they say. I try to be realistic about possibility and science is ALWAYS changing. And my mindset can't allow naysayers and the constant negativity to affect my life. My hearing does a great job of that itself. If I die with hope, it's better than living in misery because of listening to negativity.

 

Let's not get too negative with this guys; science is about experimentation, trial and error. They need to TRY things in order to get the optimal balance/dosage.

I think Otonomy will get there, they'll simply need to learn from this and figure it out.

It plays in to Frequency Therapeutics' hands though, I doubt anyone there is disappointed with this news.

 

Otividex failed, then OTO-313 failed, now this one. The future doesn’t look bright for Otonomy... and for us.

 

Seems weird to me that their previous OTO-413 trial with a lower dose showed more improvements compared to a higher dose which showed nothing.

I really hope those previous results in the lower dose trial were accurate and that OTO-413 does work.

What is next for OTO-413? Since the lower dose had more improvements, would they next go into a Phase 2b with the lower dose or have Otonomy given up and decided to not continue with OTO-413 any longer?

 

I would be surprised if Otonomy isn't done after this. This is basically their 3rd strike. OTO-413's Phase 2a study data was promising, but with this higher dose study showing no benefit it throws that into question.

I doubt there's much celebration at Frequency Therapeutics' HQ. They weren't direct competitors with Otonomy, and OTO-413 would have complimented their offerings. The only direct threat Otonomy posed to Frequency Therapeutics was their OTO-6XX work, but now I wonder if that research will ever see the light of day.

 

Just try it on tinnitus sufferers already. What do they have to lose?

 

Lots of the racetams like Piracetam and Aniracetam do, Noopept too. The strongest one though by far, is Dihexa. But if you have even a small hint of cancer in your body, it will make it grow incredibly fast. The guy who created it accidentally spilled a huge amount of it into an open cut and said he had symptoms of autism for a few days after which would point to a huge amount of extra synapses. It wears off after you stop taking it though but some people have lasting effects.

They all promote BDNF production which is the same thing that is in OTO-413. There are some that cross the blood brain barrier better too like Phenylpiracetam. Pramiracetam is supposed to be the strongest one. There are people on this forum discussing how some of these relieved their tinnitus but it doesn't really help for most people. I ordered a bunch of them to try from Intellimeds who ship from Spain and I will be trying them soon.

I think their best hope is to try and partner up with a bigger biotech firm who will aid in funding the trials. A lot of smaller companies are doing this and especially more so now with how financial tightening is occurring. All the assets they hold are dropping quickly so they have even less cash.

I've seen many people say they had relief from tinnitus with BDNF promoting supplements/nootropics so it does sound like at least some people would benefit from OTO-413.

 

How much money do Otonomy have left now? I think they should continue with OTO-413 but at a lower dose due to those improvements. I think that will be their final chance. If it does not work with more people at a lower dose, Otonomy will be done.

I wonder how long their next trial will be for the lower dose OTO-413. They seem to do trials much quicker than Frequency Therapeutics.

The previous press release mention that they were going to start OTO-413 trial in Q1/2023 once the results come out for their higher dosage.

Since the higher dose didn’t work, they should put their sole focus on successful lower dose trial. How many participants will we see in Phase 2b and how long will that trial go for?

In future trials, if companies notice success at a current dose when it comes to hearing regeneration they should never increase their dosage or do multiple dosing. That just leads to failure and hope that is a lesson that can be learned.