Otonomy OTO-413 — Treatment of Hidden Hearing Loss

Hi all.

So does this mean OTO-413 failed completely? Or is it just the higher dosing that did not show good results?

 

Nope, they had two previously good trials with 0.3mg dosage: Phase 1/2 and Phase 2a. The higher dosage during the most recent clinical evaluation failed to prove meaningful results.

Good news from April:

Otonomy Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing Loss | Otonomy Inc

Bad news from this month:

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

I was a bit worried about the thread with FX-322 where desperate patients altered their testing scores fictiously (placebo effect showed improvement which in reality was their real-world baseline score from the get go), but it wouldn't make sense since OTO-413 had multiple successful trials previous, so it should really boil down to the dosage.

 

Some news from Otonomy:

Otonomy Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Interesting information about the options considered by the company following the OTO-413 failure:

"Following these results, the company initiated an evaluation of strategic options to realize value from its pipeline including both OTO-413 and OTO-825. Strategic options could include a possible merger, business combination, sale of assets, wind-down, liquidation and dissolution or other strategic transaction. While those evaluations are ongoing, Otonomy has paused its product development activities and taken other steps to reduce costs in order to preserve its cash resources."​

It looks to me like the end might be near for Otonomy unfortunately.

 

They are toast.

 

Ah yes, shit management and hearing restoration biotech companies. Name a better duo.

 

Literally hilarious. OTO-413 probably works, there are compounds that can help us and give us our lives back but we won’t see them ever. I can’t explain my anger and disappointment. They had positive results for lower doses but screwed up OTO-313 and high doses of OTO-413.

Frequency Therapeutics will probably fail too sending the company under.

Sorry for the pessimism but this hearing stuff is no joke and I think it is one of the worst things you could ever get if you have it severe enough. I promise they will have the cure for cancer before any kind of hearing restoration drug that comes out. Probably 20-30 years unless we’re lucky. Well folks, I hope everybody enjoys their lives if they can leave their home. I’ll be in my room rotting for the next few decades.

 

@Brian Newman, I think both Otonomy's products probably worked but to such a small degree that placebo was too strong. I doubt Frequency Therapeutics will show significant improvement, but who knows hey?

 

Nothing's impossible, I won't have my hopes up though. I pray more than anything we get something soon.

 

The timing is not ideal. We previously fantasised about one company owning the knowledge / technology of both Otonomy and Frequency Therapeutics. The slow release gel, if I’m not mistaken. That is now on the table...

However, Frequency Therapeutics is under a lot of stress right now. They do not have the means to pick this up.

 

If Otonomy had tested their products on sufferers two-years or more in, it may have reduced the placebo effect and taken the wind out the "it could have been natural fading" argument. Yes, it would have been riskier for Otonomy but if they'd even got results of a 35% chance of a 25% reduction in tinnitus, then that would have sold it (for me anyway).

As it stands, there is a chance these potentially life-quality changing drugs could be squandered.

Yes, there is the potential for a buyer to take a chance with these two technologies. Can you imagine a combined gel that stimulated hair cell repair/replacement as well as re-synapsing?

Anyone know someone who would take on this challenge?

 

Possibly Syncona. Syncona acquiring AGTC (Applied Genetic Technologies Corporation) who is in partnership with Otonomy because of their gene therapy research might be interested in Frequency Therapeutics too.

You can read more about them here. They seem to be focused on finding diamonds in the rough with massive payoff potentials.

About us | Syncona (synconaltd.com)

 

The stock price more than doubled already today so potentially a deal has been made.

 

I will always have faith in greed. Always. And the only thing I have more faith in than greed alone is greed + fame.

There's some company out there who knows that if they cure hearing loss, it will be massive. Monumentally massive. There's tons of things that we can do for sight but nothing for hearing, other than hearing aids. And there's so much about hearing that we still don't know.

Someone out there is greedy enough and was bullied enough as a child to be desperate for that fame. That's where my hope is.

 

Yay, it happened Looks like the OTIC stock was a pump and dump short squeeze, but happy to have the offer go through.

Syncona Limited Portfolio Company Successfully Completes Tender Offer and Acquisition of Applied Genetic Technologies Corporation (yahoo.com)

 

Otonomy is liquidating all assets and paying stockholders any remaining revenue. Keep or dump stock?

 

BUY THE DIP.

 

I wonder where their clinical trialed drugs would end up at?

 

What a shame, OTO-413 seems to be effective at synapse regrowth. Hopefully someone like Frequency Therapeutics or another well known company can buy it and start clinical trials.

This is what happens when companies try and increase the dosage or do multiple dosing in quick succession.

 

I never invested in OTIC other than being personally hopeful like we all were, but I'm starting to think that even if their latest trial was successful, they'd still go down the same path and liquidate. I feel that was their goal from the get go to try and raise their share value without actually getting a drug out to market.

I'm hoping someone like Frequency Therapeutics picks them up to diversify their lineup and cover both bases (hearing cells and synaptopathy). I still do believe in the product as a first gen hearing treatment.

Yep, they seem to want to get it all at once (risk a grand slam when you can for sure get someone on first base). If they got something that works just a little, that's a great starter in a field where we still use antiquated tech such as hearing aids and steroid shots, and nothing else really.

Neither of these products, OTO-413 & FX-322, had adverse reactions so it's insane, everyone even with normal hearing could get this as slight booster to their hearing. Anyone, all 7+ billion people in this world. The market out there is vast and untapped and worth billions, even trillions of dollars. I don't get it why they have successful trials but then pour millions into trying to increase the effectiveness - save that for second gen treatments when you have a huge revenue stream already from the first.

 

So OTO-413 is also out of the equation as a potential remedy for us sufferers?

Is Dr. Shore’s device really our only hope of ever hearing silence again?

 

While it could potentially be a good pairing for FREQ to pick up some of the OTIC patents, FREQ doesn't have the cash pile to afford it right now. With their own current clinical plans, FREQ will be out of money sometime in 2024 if they get no further milestone payments or raise capital via a stock offering.

 

If the OTO-413 trial demonstrated more convincing positive outcomes, they would certainly not have gone down the same path. They would have options to continue to fund development that they don't have today. It's possible they would have considered an acquisition prior to a successful OTO-413 trial, but dissolving and cashing out would have been unlikely.

Won't happen. They don't have the cash and the OTO-413 IP doesn't fit their PCA approach model.

 

Wel, it's been real Otonomy but at least your company cared enough to at least
try, so therefore

feels like the ending of an era though. All the ups and downs finally coming to a sad ending.

 

Most people habituate so they don't actually hear their tinnitus 24/7.

There are almost 50 drugs being trialed for hearing loss. One of them will probably at least reduce the level of tinnitus at some point but there's unlikely to be a 100% cure imo.

You are still very early stages and might recover naturally and if you don't, then you will habituate. Even people with severe tinnitus can habituate.

 

They're not officially closing up shop yet though. But it does look dire. I still think another big biotech firm might acquire them but the whole situation with the finances is dicey right now with interest rates so high, so maybe late next year when rates start to come down again.

 

It seems the only thing Otonomy is able to clearly demonstrate is their inability to get their drugs over the finish line. I'm glad I only lost a few hundred dollars. What I haven't lost is hope. Thank you everyone who has contributed time and knowledge to this thread and the research threads in general.

 

I still have hope with OTO-413. Only reason for their failure was them increasing the dosage. I wonder if they had kept it at 0.3 mg, would their trial have succeeded to the point where it comes out in the market? I’m not sure. We would have known if there was any benefit or not if they had tested it with at least 100 people or more in their Phase 2 trial with 0.3 mg.

 

BDNF has been shown to be beneficial for treating other issues like strokes. I think that intratympanic injection for this in some form might be possible in the near future, because of how important it is for the human body. I'm sure everything will work out.

 

I hope they find a potential buyer who can start and finish off the OTO-413 trials ASAP. I don’t really want them to delay too long as there was already a benefit with the 0.3 mg dose.

Anyone here have an idea on how much Otonomy will sell their OTO-413 IP for?

 

Damn they couldn't even find a buyer for their remaining IPs.