Otonomy OTO-6XX — Hair Cell Regeneration

For sure that's relieving to hear.

If they do a trial in Australia I will sign up for it 100% and I'll do a review of it and post it up here if I get accepted. Obviously after the confidentiality agreement is over.

Otherwise I'll be looking to travel to wherever it's available first haha.

 

I don't think right now that there will be any trials for any of these treatments in Australia as the firms are based in North America and also most of the pharma companies which they have partnered with seem to be in Asia and/or Europe. Essentially they are able to trial the medicine there as there would probably be a sufficient number of people to actually work with.

I am actually also in the same boat as you and would happily partake in trials if they were run in Australia, although I have a feeling that we will be buying this lol.

Look at it this way however, we are thankfully very likely to get the medicines here ASAP after release due to the government allowing us to get medicines as soon as they meet the American requirements. Also at this stage if these treatments turn out to be successful then I can see them being offered and/or administered through the specialist hospitals like the Eye and Ear in Melbourne because based off of the government's views on supporting the provision of medicine I can absolutely see them assisting everyone to make these treatments available.

 

What is the mechanism of action of OTO-6XX to regenerate hair cells? Is it something that activates progenitor cells like FX-322 and causes cell division? Or is it the type of γ-secretase inhibitor that transforms supporting cells into hair cells? Is it a different mechanism of action that is different from Audion and FX-322, that does not interfere with patents? I don't know even if I look it up on the internet. Does anyone know?

 

They haven't released the mechanism of action yet as far as I know. Very, very little is known about it. As it moves to clinical (a timeline isn't known for that either), we would know more.

 

I hope that this moves to clinical trials soon since there is now an agreement with Kyorin on the medicine. It will be interesting to see how OTO-6XX and all the other similar medicines compare to FX-322.

 

I definitely didn't see this though this is really interesting to know. I reckon that this then explains why Otonomy is partnering with them.

Apparently Kyorin has made the compound for this medicine and has agreed to partner with Otonomy in order to utilise their drug dosing/drug delivery technique to treat people with the medicine.

This tells me that Otonomy may have a somewhat more advanced method of dosing people than what Kyorin maybe could offer themselves and hence why this agreement has been made with each other. This seems like a significantly positive move.

 

Is Otonomy's gel so good? Is it true that a single injection can reach the depths of the cochlea? Is it really better than the Frequency Therapeutics gel? Is Frequency Therapeutics impossible to improve in-house without patent permission from Otonomy?

 

Their gel is extended release, which has definite and unique benefits.

All we know so far is that it seems more effective when used in OTO-104 vs regular Dexamethasone and this is for two reasons: it maintains elevated levels of drug longer and the gel seems to solve some of the polarity issues with IT steroids.

How this translates to other drugs should be known soon though because the results of OTO-413 will be out by end of year.

 

It seems very effective in Otividex trials too, especially with how deep it goes. Got a feeling that this is why there is a lot of promise with the treatment.

The question isn't necessarily at this stage which gel is better but basically which dosing method is better. We know that the dosing method of Otonomy's treatments is initially looking like it is superior to Frequency Therapeutics. What we won't know though is whether Frequency Therapeutics or Otonomy's medicine is more effective. Essentially it might come down simply to drug dosing although we don't know yet till the trial results are published.

Right now if it is a case of Otonomy's method of dosing being patented, then I cannot see how Frequency Therapeutics could be allowed to utilise it, especially with the agreement Otonomy has entered into with Kyorin. This tends to be why I think that there will be some attempt made by Frequency Therapeutics to look at redosing in the future using either a technique that is widely available or by entering into a deal with a dosing company.

 

Promising research. We'll see how it pans out. The regrowth of the IHC, which were essentially non-existent is very promising indeed. Though the chaotic nature is a concern. Still, impressive.

 

Sorry what are you referring to when you say chaotic nature? Just want to clarify for my own understanding.

 

Do we have such pictures also for FX-322 and Audion?

 

As far as Audion, they have released comparatively little info that's publically available (perhaps more is available in research circles).

Frequency Therapeutics released this but it's in culture:

Clonal Expansion of Lgr5-Positive Cells from Mammalian Cochlea and High-Purity Generation of Sensory Hair Cells

And they already confirmed in the podcast that they don't have supernummery cells in vivo though they have proliferation in culture so the appearance would be different.

OTO-6xx is still pre clinical and i'm not sure what the conditions were for those histologic photos.

 

OTO-6XX I think will probably move out of pre-clinical very soon since they have now signed that agreement.

 

Honestly if they work properly, I'm down for extra hair cells. Having more functioning hair cells could be an answer to people with conductive hearing loss.

 

Why would that help people with conductive loss?

 

I figured more hair cells would equal more amplification. I'm probably wrong.

 

In Otonomy's press release today they mention they're "formulating the patent-protected compound [OTO-6XX] utilizing the company’s proprietary technology to provide sustained drug exposure in the inner ear following a single local administration." [1]. I'm assuming they're doing animal tests right now, and maybe they'll present those results early next year? I'm a bit curious when they'll start the Phase I/II study, though I'm sure they want to make sure they have all of their bases covered before they jump in.

In their press release today they also say they're "pleased with the progress we are making in our preclinical programs", so I'm assuming they're happy with what they're seeing so far. Definitely a bummer we have so little to go off of at the moment. Maybe when the Tinnitus Talk Podcast talks to them they can squeeze out a bit more information. I'm really curious if they'll be able to reach the lower frequencies.

[1] https://investors.otonomy.com/news-...orts-third-quarter-2020-financial-results-and

 

If they are marketing this as a compound with potential benefit for severe hearing loss patients, I'm curious to know its mechanism of action. Hope they provide more info on this soon.

If FX-322 needs support cells to work then I wonder if OTO-6XX would work on those with severe to profound hearing loss. If so, would it only restore the frequencies in severe hearing loss range or a full restoration including those frequencies in profound hearing loss range?

I've wondered if any of these treatments in store are able to do a full restoration of even the profound hearing loss ranges as long as it's not a fully flat profound hearing loss to begin with.

 

There is a treatment that is being looked into for severe to profound hearing loss by Hough Ear Institute and Sound Pharmaceuticals which is for severe to profound hearing loss. I think with FX-322 it can regenerate everything although you just need to have enough support cells consequently to activate it. I am thinking we will get more information about OTO-6XX medicine when it gets closer to the time that they can start trialling it. It could be that their medicine might do the same stuff as FX-322 though they tend to know it will work with a wider range of hearing loss.

 

If insurance doesn't cover it, I'll take a 2nd mortgage against my house.

 

How much do you guys think this thing is going to cost?

 

No idea. If it actually works and cures hearing loss and tinnitus; a lot. At least until the patent runs out and it becomes generic.

But think about this, even if it cost 10 grand per ear and it completely fixes your hearing loss and tinnitus, the VA would be all over that. They spend over a billion dollars a year just on disability payments and more for hearing aids, which suck by the way.

The VA has to pay for a new set every five years at five or six thousand each time.

 

I decided to shoot Otonomy's Investor Relations an email about the status of OTO-6XX. They replied back:

Hi Patrick,

Thank you for your message. We are continuing preclinical development work for the OTO-6XX program and will provide an update when we have substantive new information to report.

With best regards,

Paul​

I tried to get further info on when they might actually release new info but they were pretty tight lipped:

Sorry, I can’t commit a timeframe for an update to you right now.​

Paul is the CFO, interesting that's he's answering these emails, though also kind of neat.

I don't think this really tells us anything, though I'm at least glad he says they're still working on it.

 

If OTO-6XX gel is the same as OTO-413 and consequently target a large part of the cochlea, is there any chance for this drug to outperform FX-322?

 

We don't have enough data.

 

I don't think we have any, including mechanism of action or any pre-clinical studies yet.

 

So, we don't have a timetable as to when they are going to start clinical trials? Are they still developing the drug?

 

A guy got back to me today. He said they were nowhere close to starting clinical trials; might as well forget about this one.

 

Could you please post the email or conversation?