Otonomy OTO-313 — Treatment of Tinnitus

New studies are starting/completing daily on ClinicalTrials.gov. I don't post everything but in the last weeks some new studies closed recruiting and some new ones started. There are so many more studies going on that we are not even aware of e.g., at local universities etc.

Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

The Study of Wuling Capsule in Treatment Chronic Tinnitus

 

Another failure to add to the bonfire of failures. The only thing I look at on the forum is the Research News section under the misguidance of there being some hope of treatment, but with FX-322, this, Dr. Shore being unable to publish any results after a decade of work, it just seems that there is none coming in any meaningful timeframe to help anyone who's currently afflicted.

Don't know why I keep looking just to get hopes dashed. It seems like an effort in futility at this point.

Seems like it's more harm than good to have hope of help from an external source. This is a battle you fight alone.

 

Don't give up hope. Science is just learning how not to cure tinnitus right now.

Science is more about failure than it is success. Stay strong. One day a cure will be discovered.

 

Weber's comments re: Placebo sound eerily similar to the FX-322 Phase 2A comments from Lucchino.

 

Fully empathise. What I would say is good luck to Otonomy. Why?

1) They came onto the Tinnitus Talk Podcast.
2) They 'got on with it.' No messing around, all done promptly and within promised timelines.

I share the pain. I want them to bounce back after the pain goes.

 

Posting this Monthly stock reference chart for closure. Obviously little to no chance of accumulation now as it's gapped down into penny-stock territory on the August open. Hope no-one here lost money.

 

I had put all my hopes on this drug...

How can they get our hopes up so high and then tell us that it doesn't work after all? For the money?

A Treatment For Tinnitus Is On The Horizon....

Why?

 

They are looking at 'other' cash flows... so sacking most of their staff then.

 

Someone was tipped last week on the trial results. SEC?

 

I lost all hope and money.

 

Yesterday (July 31st) Treble Health sent out a newsletter outlining a few 'promising' avenues of research, and this is what was listed. Just impeccable timing:

 

The main problem we are going to have with injections is we don’t know if the drug is getting where it needs to go.

Ultimately implants, inner or outer brain stimulation is going to be the way.

 

I thought it had gone well in Phase 1 and there was evidence it worked. I don't know how and why it failed so hard now...

 

To be honest I never had much hope for this one. Didn't we determine tinnitus was a brain problem rather than an ear problem over 10 years ago?

 

The Ebselen from Sound Pharmaceuticals seems to be the most promising drug currently as they have completed the Phase 2 trial and are now starting Phase 3. If it does not fail, it may be available in a few years.

 

I think they all need to rework their trial designs. Forget about short term tinnitus sufferers who can have natural improvement, forget about people who it's a minor nuisance to.

Get people who have been suffering in a living hell for years and get stuff to work for those. If it works for those, you will have a viable treatment and there would be no doubt of it being placebo.

It's no good getting something that barely works for a tiny minority of people who meet a shallow criteria and hyping it up like it's some sort of help to anyone.

And I just want to wish all the best to everyone suffering. There is no help from science or the medical community but we are not alone, we just got to keep fighting everyday to get through this for our loved ones.

Hopefully one day we will get some good news. Surely there is someone on the planet that can figure out how ears work.

 

When Otividex failed for the first time they cut 33% of their staff. They'll probably do something similar or more drastic this time. They have $53M in cash and they're burning around $25M every 6 months, so what they have now will only take them into the middle of next year. That's not long enough to do a Phase 2b trial of OTO-413. Even with staff cuts they'd never be able to make it through a Phase 3 trial. Their market cap (as of me typing this) is $17M. There's no way they'd be able to raise enough capital with a stock offering. I only see 2 paths forward:

• Partner with a larger company (similar to what Frequency Therapeutics did with Astellas). The other company would get certain rights (maybe international rights), and they'd pay for the trials.
• Liquidate the company, sell OTO-413 off to another company that could run the needed trials. Just based on Otonomy's market cap, this seems like the more likely option. Otonomy really has no leverage. If you're someone like Astellas, why would you pay for trials? Why not just offer Otonomy's board $25M for the company?

The more I think about this, the more I think this is the end of Otonomy. The silver lining is that if someone like Astellas buys Otonomy, they can share the slow release gel tech with other companies they're working with like Frequency Therapeutics.

Another observation: 23M Otonomy shares have traded hands today. There's a total of 57M outstanding shares. That means roughly 40% of Otonomy's shares have changed hands today.

 

oof

They only recruited sufferers of <6 months, correct? How do you manage placebo effect in that case. A portion of those were going to naturally get better without any treatment.

 

Perhaps with such an acquisition we'll one day see a joint medicine that tackles multiple avenues of treatment. Regenerative mixed with symptom reduction and maybe potassium channeling. As sad as this may be for Otonomy and people banking on its success, this can lead to advances down the road.

 

Sorry guys - saw the bad news today.

Just got to look at other areas now.

Seems quite a few of us were not that hopeful with OTO-313.

Dr. Susan Shore is the one to watch in my opinion.

 

Up to 12 months.

 

This was my thinking. Combine and collaborate. They have the delivery technology.

Partner with a company with promising molecules and work together. A contract on rights can be drawn up.

Otonomy can still be part of something groundbreaking but not on their own and not after today.

They would need highly significant results for OTO-413 that would lead to a successful Phase 3 trial to pull them out.

They have nothing else in clinical phase.

 

The sad realization is we may be the ones who suffer for the future.

Sucks.

 

It may be redundant at this point but the fact that the OTO-313 was trying to tackle a symptom and not what's causing the symptom was a bad sign from the get go. Still glad they tried it but stuff trying to solve hearing loss and/or nerve damage related to hearing seems the way to go.

 

This would be a good time for Astellas to buy them. Astellas seems eager to get into the hearing space. Even if OTO-413 Phase 2+ looks good, it's still at a a discount.

 

If Dr. Susan Shore's device works, why wouldn't they initially market it as a non-medical device and use the feedback from that to determine its actual efficacy, then if the feedback is positive, move forward with FDA approval as a medical device? Wouldn't that be a viable way to raise capital for further testing?

I've only recently started researching tinnitus treatments and cures but so far all I've found are dead ends (OTO-313, etc..), snake oil (flavonoids, lipids, etc...), outright scams and frauds (again, flavonoids, lipids, and countless others...) and well-meaning people and researchers who have minimal to zero legitimate results to show for their efforts (Dr. Susan Shore at the moment, might also fit under the dead ends), purely experimental stuff (CBD, etc...) and treatments that can help but often at the expense of equally debilitating or in some cases dangerous results (benzos, Gabapentin, etc...).

The best I've seen are aids that supposedly help people habituate but even those have questionable efficacy (Lenire, Neosensory, et al...). Then there are the do-it-yourself treatments most of which are free (notched-sound therapy, etc..) and seem to be just as effective as the expensive stuff like Lenire and Neosensory (which I'm not yet convinced don't belong in the snake oil section... one of the wealthy Texas Roadhouse execs apparently tried Lenire and we've heard about how effective that was for him...).

How much would a tinnitus cure or treatment really be worth to a company that developed it? How much would people with genuinely debilitating tinnitus be willing to pay for even just a treatment that would reduce the severity to a more manageable level, never mind an actual cure?

 

Agreed. Stratification of tinnitus, or the lack thereof, is a massive problem where trial design is concerned. It is so self-defeating and hurts everyone, especially those of us suffering chronic severe tinnitus.

I think the solution to this will lie with an objective tinnitus measurement tool. At least the people at the Bionics Institute are attempting to chase that problem down.

 

Plenty of people have hearing loss without tinnitus.

 

It would be interesting to see the results and hear what the patients had to say who received the treatment (actual and placebo).

 

Hence the nerve damage. OTO-413 is intended to heal the synapses related to hearing instead of the hair cells.