Otonomy OTO-413 — Treatment of Hidden Hearing Loss

[d'Wooluf]

Why is Frequency Therapeutics' hydrogel inferior to Otonomy's?

Totally uninformed speculation: Langer's thing is drug delivery. Langer is the biggest name they've got and he's also the expert on turning science into money. They wanted him onboard, therefore, when it came to drug delivery he's the one they turned to.

 

[Joeseph Stope]

Totally uninformed speculation: Langer's thing is drug delivery. Langer is the biggest name they've got and he's also the expert on turning science into money. They wanted him onboard, therefore, when it came to drug delivery he's the one they turned to.

Reading up on the various methods of getting the stuff inside the cochlea, not only by Frequency Therapeutics, but by some of the other outfits too... Like the Moon landing or Mars landing, I thought to myself.

One crowd had some idea with micro-needles of some sort... sorry, I've lost the link.

Then this magnetic gel. Who woulda thunk it? If it gets there and does the trick, great.

 

[tommyd87]

Reading up on the various methods of getting the stuff inside the cochlea, not only by Frequency Therapeutics, but by some of the other outfits too... Like the Moon landing or Mars landing, I thought to myself.

One crowd had some idea with micro-needles of some sort... sorry, I've lost the link.

Then this magnetic gel. Who woulda thunk it? If it gets there and does the trick, great.

Something will get the medicine there. There is a lot of drug delivery work being done across all the ear medicine companies and also externally in the drug delivery space.

There is a lot of interest in this and I am actually thinking that they now realise how beneficial and lucrative an industry it is.

 

[Joeseph Stope]

Something will get the medicine there. There is a lot of drug delivery work being done across all the ear medicine companies and also externally in the drug delivery space.

There is a lot of interest in this and I am actually thinking that they now realise how beneficial and lucrative an industry it is.

Finally the people with the resources are asking the right questions. Like: "How do you deliver the drug" and "what does it look like inside in there".

Hough Ear Institute/Justin De Moss mentioning some objective way of measuring detecting or seeing tinnitus is tantalizing to us all as to what he could mean.

Let me sing praises for the Tinnitus Talk team from the rooftops.

I was getting a kind of queasy feeling a while back that ummm… should this site be called LeveredFinancialTalk.com or some such name. But that is the American way. Once the markets smell the whiff of money they want to know all about it. Europeans do things differently like in the universities and such-like and give one another titles, promotions and even Nobel prizes as incentives.

So I would just like to repeat: Figure out how much you can afford to lose. That's the amount you can play around with in the markets. Have a wild ride. -- in the markets that is.

Just from reading the posts here it would seem that some sufferers are really financially savvy. But most are pretty vulnerable and maybe easily led.
My two cents.

 

[tommyd87]

Finally the people with the resources are asking the right questions. Like: "How do you deliver the drug" and "what does it look like inside in there".

Hough Ear Institute/Justin De Moss mentioning some objective way of measuring detecting or seeing tinnitus is tantalizing to us all as to what he could mean.

Let me sing praises for the Tinnitus Talk team from the rooftops.

I was getting a kind of queasy feeling a while back that ummm… should this site be called LeveredFinancialTalk.com or some such name. But that is the American way. Once the markets smell the whiff of money they want to know all about it. Europeans do things differently like in the universities and such-like and give one another titles, promotions and even Nobel prizes as incentives.

So I would just like to repeat: Figure out how much you can afford to lose. That's the amount you can play around with in the markets. Have a wild ride. -- in the markets that is.

Just from reading the posts here it would seem that some sufferers are really financially savvy. But most are pretty vulnerable and maybe easily led.
My two cents.

This is a very fair point. I feel that the follow the money trail theory is a good one for you to put out there.

Therefore although finance should not be a major factor in this area, I think the show me the money option is going to help especially when it comes to getting results with stuff. This is a necessary driver for better results.

 

[Indra]

I was reading articles about BDNF vs NTF3 for regenerative purposes and it seems like we would want an option for both. One study seemed to say NTF3 was superior for a certain synapse regeneration task but that is just one paper out of many and I have not fully dived into all the research and their reasoning, but I imagine Otonomy has checked both.

The question is can either one fully regenerate the same synapses to the same efficacy and which has the best profile overall? If both are viable then it would be nice if someone created a formulation of that as a drug.

These are well-known substances, with studies about each already. Would be nice if some ENT holistic physician with a compounding pharmacy could try these substances compounded and some kind of gel without having to go through this whole process but I understand how it is. Perhaps there is a way.

Anyone else looked into Neurotrophic Factor 3 vs. Brain Derived Neurotrophic Factor for this purpose?

Also I know I'm getting off topic but it seems to me that I don't yet see is solution for growing a new spiral ganglion neurons although perhaps this is not the root cause of almost any of our problems.

I just know that salicylate set me off like crazy when I was at a stable point and high doses of them can kill sgn but in my case a single day of 2400mg 5-ASA (should be much less absorbed, and it is a drug I took before my ear injuries) shouldn't really cause too much of an effect but whatever it did was like 50 setbacks combined into one that I'm still recovering from, didn't even have ringing every day, just reactive tinnitus until that. I have hyperacusis and tinnitus and a whole host of symptoms so I just want to regenerate everything I can.

 

[FGG]

I was reading articles about BDNF vs NTF3 for regenerative purposes and it seems like we would want an option for both. One study seemed to say NTF3 was Superior for a certain synapse regeneration task but that is just one paper out of many and I have not fully dived into all the research and their reasoning, but I imagine otonomy has checked both.

the question is can either one fully regenerate the same synapses to the same efficacy and which has the best profile overall? if both are viable then it would be nice if someone created a formulation of that as a drug.

These are well-known substances, with studies about each already. Would be nice if some ENT holistic physician with a compounding pharmacy could try these substances compounded and some kind of gel without having to go through this whole process but I understand how it is. Perhaps there is a way.

Anyone else looked into neurotrophic Factor 3 verse brain derived neurotrophic factor for this purpose?

Also I know I'm getting off topic but it seems to me that I don't yet see is solution for growing a new spiral ganglion neurons although perhaps this is not the root cause of almost any of our problems.

I just know that salicylate set me off like crazy when I was at a stable point and high doses of them can kill sgn but in my case a single day of 2400mg 5-ASA (should be much less absorbed, and it is a drug I took before my ear injuries) shouldn't really cause too much of an effect but whatever it did was like 50 setbacks combined into one that I'm still recovering from, didn't even have ringing every day just reactive until that. I have hyperacusis and tinnitus and a whole host of symptoms so I just want to regenerate everything I can.

Otonomy's own recent study showed BDNF worked better, so I'm sure that's why they went with it:

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224022

 

[tommyd87]

I was reading articles about BDNF vs NTF3 for regenerative purposes and it seems like we would want an option for both. One study seemed to say NTF3 was superior for a certain synapse regeneration task but that is just one paper out of many and I have not fully dived into all the research and their reasoning, but I imagine Otonomy has checked both.

The question is can either one fully regenerate the same synapses to the same efficacy and which has the best profile overall? If both are viable then it would be nice if someone created a formulation of that as a drug.

These are well-known substances, with studies about each already. Would be nice if some ENT holistic physician with a compounding pharmacy could try these substances compounded and some kind of gel without having to go through this whole process but I understand how it is. Perhaps there is a way.

Anyone else looked into Neurotrophic Factor 3 vs. Brain Derived Neurotrophic Factor for this purpose?

Also I know I'm getting off topic but it seems to me that I don't yet see is solution for growing a new spiral ganglion neurons although perhaps this is not the root cause of almost any of our problems.

I just know that salicylate set me off like crazy when I was at a stable point and high doses of them can kill sgn but in my case a single day of 2400mg 5-ASA (should be much less absorbed, and it is a drug I took before my ear injuries) shouldn't really cause too much of an effect but whatever it did was like 50 setbacks combined into one that I'm still recovering from, didn't even have ringing every day, just reactive tinnitus until that. I have hyperacusis and tinnitus and a whole host of symptoms so I just want to regenerate everything I can.

I think there are a few parts to what you are saying about Otonomy's choice of treatment/choice of trigger to initiate synapse restoration in the ear.

1. I think that the BNDF method of synapse restoration is not used only by Otonomy but I am pretty sure it might be used by other companies working on synaptic recovery too.

2. The lab evidence of Otonomy's pre-trial work indicates that the BDNF outcomes showed that they were quite successful at restoring a normal/required amount of synapses. Thus this is why I believe Otonomy might be using this method in their approach.

3. I feel that Otonomy believes that they can achieve a good functional gain from their treatment.

4. Regarding Spiral Ganglion Neurons, I have seen nothing on this either and maybe it is because it isn't needed. @FGG got any info lol ?

 

[FGG]

I think there are a few parts to what you are saying about Otonomy's choice of treatment/choice of trigger to initiate synapse restoration in the ear.

1. I think that the BNDF method of synapse restoration is not used only by Otonomy but I am pretty sure it might be used by other companies working on synaptic recovery too.

2. The lab evidence of Otonomy's pre-trial work indicates that the BDNF outcomes showed that they were quite successful at restoring a normal/required amount of synapses. Thus this is why I believe Otonomy might be using this method in their approach.

3. I feel that Otonomy believes that they can achieve a good functional gain from their treatment.

4. Regarding Spiral Ganglion Neurons, I have seen nothing on this either and maybe it is because it isn't needed. @FGG got any info lol ?

Rinri Therapeutics is working on neuron regeneration but this isn't a problem for most people (unless you have very specific diseases like MS or GBS).

 

[tommyd87]

Rinri Therapeutics is working on neuron regeneration but this isn't a problem for most people (unless you have very specific diseases like MS or GBS).

Yeah you see I didn't think that this was a problem for most. Hence why I have seen nothing explicitly linking most hearing related issues with the neuron regeneration.

Thanks.

 

[serendipity1996]

Otonomy's September 2020 Corporate Presentation is available - not sure if this has already been posted?

https://investors.otonomy.com/static-files/5d9cb779-996b-49b3-b162-8285d00b6e71

 

[tommyd87]

Otonomy's September 2020 Corporate Presentation is available - not sure if this has already been posted?

https://investors.otonomy.com/static-files/5d9cb779-996b-49b3-b162-8285d00b6e71

Otonomy seems to be fairly well run too. I think that they are following a similar reporting path to Frequency Therapeutics which is what makes their information easy to understand and clearly communicated.

It is incredibly reassuring to know that Otonomy also seems to be fully focused on delivering positive outcomes to people.

 

[tequilaman69]

Otonomy seems to be fairly well run too. I think that they are following a similar reporting path to Frequency Therapeutics which is what makes their information easy to understand and clearly communicated.

It is incredibly reassuring to know that Otonomy also seems to be fully focused on delivering positive outcomes to people.

Couldn't agree more, hence why I'm in so heavy on them from an investment standpoint.

 

[patorjk]

Couldn't agree more, hence why I'm in so heavy on them from an investment standpoint.

If you don't mind saying (and you don't have to if you're not comfortable), how much do you have invested? And what got you into the company in the first place?

After doing more reading and thinking about this more, I decided to take the plunge and sold 200 of my FREQ shares late last week and yesterday bought some OTIC (1500 for 3.685). I worry that I'm not heeding my own advice on investing in companies I'm emotionally invested in, but figured that since I've put aside some money for risky companies, it's best not to have it all in just 1 company.

Back in 2017 I owned around ~467 shares of OTIC which I'd purchased for around $15 a share. However, I got cold feet and thankfully sold right before it crashed. It's kind of surreal to now own 3 times as much for a significantly smaller price.

 

[Joeseph Stope]

In search of some kind of plan of action to deal with my tinnitus.

On the one hand I have got so excited over the Frequency Therapeutics approach... but they deal mostly with hair cells -- they repair synapses only in so far as the corresponding hair cells with the synapses are replaced/repaired.

Then I figured out that synapse damage might be the most likely trouble.

So do I count my money and say to myself: "Go for the cheapest one…" Say for example Hough Ear Institute or Otonomy.

And if that doesn't work, then try the (let's say more expensive) Frequency Therapeutics or Pipeline Therapeutics.

Or do I think: "Say these intratympanic injections scare me. Go for a safer one."

Or do I try to figure out which one would be the most likely remedy.

Life gets more and more complicated I guess...

 

[FGG]

In search of some kind of plan of action to deal with my tinnitus.

On the one hand I have got so excited over the Frequency Therapeutics approach... but they deal mostly with hair cells -- they repair synapses only in so far as the corresponding hair cells with the synapses are replaced/repaired.

Then I figured out that synapse damage might be the most likely trouble.

So do I count my money and say to myself: "Go for the cheapest one…" Say for example Hough Ear Institute or Otonomy.

And if that doesn't work, then try the (let's say more expensive) Frequency Therapeutics or Pipeline Therapeutics.

Or do I think: "Say these intratympanic injections scare me. Go for a safer one."

Or do I try to figure out which one would be the most likely remedy.

Life gets more and more complicated I guess...

The odds are good that Otonomy and Frequency Therapeutics will not come out at the same time. They will at minimum be 6 months apart. If possible, if it were me, I'd try the available one first.

Both Otonomy and Frequency Therapeutics would likely start their final trials next year. Hough Ear Institute will be behind both of these companies time line wise.

 

[patorjk]

In search of some kind of plan of action to deal with my tinnitus.

On the one hand I have got so excited over the Frequency Therapeutics approach... but they deal mostly with hair cells -- they repair synapses only in so far as the corresponding hair cells with the synapses are replaced/repaired.

Then I figured out that synapse damage might be the most likely trouble.

So do I count my money and say to myself: "Go for the cheapest one…" Say for example Hough Ear Institute or Otonomy.

And if that doesn't work, then try the (let's say more expensive) Frequency Therapeutics or Pipeline Therapeutics.

Or do I think: "Say these intratympanic injections scare me. Go for a safer one."

Or do I try to figure out which one would be the most likely remedy.

Life gets more and more complicated I guess...

If any of these companies are successful we should be extremely grateful. And if all of them are, then the complication of choosing which way to go will be a great problem to have.

The sad state of the tinnitus world right now is that doctors have no way of differentiating what causes a particular person's tinnitus (hair cell issues, synapse damage, etc). So even after these drugs come out, we may end up just having to try each one until something works.

Also, as an aside, though OTO-413 repairs synapses, their study excludes tinnitus patients. The goal of the drug is to improve hearing. So we won't know if OTO-413 helps with tinnitus. They've also recently licensed a compound for OTO-6XX, which will regenerate hair cells. It'll be interesting to see how that does compared to FX-322. At this point though, that drug is probably several years behind FX-322.

 

[tequilaman69]

If you don't mind saying (and you don't have to if you're not comfortable), how much do you have invested? And what got you into the company in the first place?

After doing more reading and thinking about this more, I decided to take the plunge and sold 200 of my FREQ shares late last week and yesterday bought some OTIC (1500 for 3.685). I worry that I'm not heeding my own advice on investing in companies I'm emotionally invested in, but figured that since I've put aside some money for risky companies, it's best not to have it all in just 1 company.

Back in 2017 I owned around ~467 shares of OTIC which I'd purchased for around $15 a share. However, I got cold feet and thankfully sold right before it crashed. It's kind of surreal to now own 3 times as much for a significantly smaller price.

I have just over 67K shares with an avg. price of roughly $3.80 per share, so all in all about $254K invested.

To be honest, I got into it initially as a chart play when it was in the mid 4's a few months ago, as the chart looked great. As I researched more into the company and the price yo-yo'd, I kept buying more, averaging down. I really like the story, along with the institutional ownership and analyst coverage. I think the risk/reward is pretty solid, as they just need to deliver only one or two of the initiatives they're working on.

On the flip side, it's been pretty frustrating at times watching how every significant move gets sold into, but there hasn't been a real catalyst. So we sit and wait in the meantime, and possibly will add more if it drops down in the low 3's.

 

[patorjk]

I have just over 67K shares with an avg. price of roughly $3.80 per share, so all in all about $254K invested.

To be honest, I got into it initially as a chart play when it was in the mid 4's a few months ago, as the chart looked great. As I researched more into the company and the price yo-yo'd, I kept buying more, averaging down. I really like the story, along with the institutional ownership and analyst coverage. I think the risk/reward is pretty solid, as they just need to deliver only one or two of the initiatives they're working on.

On the flip side, it's been pretty frustrating at times watching how every significant move gets sold into, but there hasn't been a real catalyst. So we sit and wait in the meantime, and possibly will add more if it drops down in the low 3's.

That's a pretty impressive investment. They have a lot of important milestones coming up (as you're probably already well aware), so I have to imagine there's going to be a big shift in direction within the next couple of months. However, I don't see any important news coming before November (in August they said the OTO-413 study was almost full, and the study takes 3 months). If OTO-413 and OTIVIDEX prove to be successful, I think the company will be in a really good spot. I was actually kind of wondering what it would take for the company's stock to return to its 2017 value. I believe its market cap was around 800M at that point.

 

[tommyd87]

The odds are good that Otonomy and Frequency Therapeutics will not come out at the same time. They will at minimum be 6 months apart. If possible, if it were me, I'd try the available one first.

Both Otonomy and Frequency Therapeutics would likely start their final trials next year. Hough Ear Institute will be behind both of these companies time line wise.

I still think that we would need to use both a synapse treatment and also a hair cell treatment. The view I have (and what is suggested by some of the research as well) is that while both hair cells and synapses will benefit from OTO-413, the hair cell benefit will not be anywhere near as comprehensive as what it would be with a specific hair cell medicine. The same can be said for FX-322 where the synapse benefit won't be anywhere near as comprehensive as it would be with something like OTO-413. Thus I feel that it won't be wasted taking both medicines.

That's a pretty impressive investment. They have a lot of important milestones coming up (as you're probably already well aware), so I have to imagine there's going to be a big shift in direction within the next couple of months. However, I don't see any important news coming before November (in August they said the OTO-413 study was almost full, and the study takes 3 months). If OTO-413 and OTIVIDEX prove to be successful, I think the company will be in a really good spot. I was actually kind of wondering what it would take for the company's stock to return to its 2017 value. I believe its market cap was around 800M at that point.

I agree that this would put the company in an excellent financial position. Pretty much now I need to go and buy shares

 

[tequilaman69]

That's a pretty impressive investment. They have a lot of important milestones coming up (as you're probably already well aware), so I have to imagine there's going to be a big shift in direction within the next couple of months. However, I don't see any important news coming before November (in August they said the OTO-413 study was almost full, and the study takes 3 months). If OTO-413 and OTIVIDEX prove to be successful, I think the company will be in a really good spot. I was actually kind of wondering what it would take for the company's stock to return to its 2017 value. I believe its market cap was around 800M at that point.

Based on a few analyst reports I've seen, I see targets in the $9-$11 range, but the market is completely crazy now when good news comes out, so could really gain momentum and additional analyst coverage to hit the $20-$30 range...especially given OTO is dealing in a field where they could be pioneers if they hit.

 

[tequilaman69]

I still think that we would need to use both a synapse treatment and also a hair cell treatment. The view I have (and what is suggested by some of the research as well) is that while both hair cells and synapses will benefit from OTO-413, the hair cell benefit will not be anywhere near as comprehensive as what it would be with a specific hair cell medicine. The same can be said for FX-322 where the synapse benefit won't be anywhere near as comprehensive as it would be with something like OTO-413. Thus I feel that it won't be wasted taking both medicines.

I agree that this would put the company in an excellent financial position. Pretty much now I need to go and buy shares

Actually another reason I like Otonomy is because they are in a pretty strong financial position, especially after the secondary raise in July which was gobbled up in just days. At last check I think they have about $80m to $90m on their balance sheet which would give them at the very least a 2 year runway.

 

[tequilaman69]

Another investor presentation @ Oppenheimer just concluded. Q/A starts around the 16:00 mark:

https://wsw.com/webcast/oppenheimer5/otic/2715615

 

[Paul38]

I don't think hearing aid companies should be too concerned with OTO-413 as it addresses a condition not treatable by hearing aids: hidden hearing loss. Hearing aids only work when you've lost outer hair cells which are biological amplifiers. The hearing aids simply do the amplification. I don't think amplification really does anything for cochlear synaptopathy.

 

[tomytl]

I don't think hearing aid companies should be too concerned with OTO-413 as it addresses a condition not treatable by hearing aids: hidden hearing loss. Hearing aids only work when you've lost outer hair cells which are biological amplifiers. The hearing aids simply do the amplification. I don't think amplification really does anything for cochlear synaptopathy.

Is OTO-413 also meant to help people with long term hearing loss, or just acute?

 

[FGG]

Is OTO-413 also meant to help people with long term hearing loss, or just acute?

Long term.

You might be thinking of OTO-313 which is for acute cases.

 

[tommyd87]

I don't think hearing aid companies should be too concerned with OTO-413 as it addresses a condition not treatable by hearing aids: hidden hearing loss. Hearing aids only work when you've lost outer hair cells which are biological amplifiers. The hearing aids simply do the amplification. I don't think amplification really does anything for cochlear synaptopathy.

I have commented about this before but hearing aid companies would probably have concerns with OTO-413. Hearing aids are available with programs which supposedly help with hearing speech in background noise. These hearing aids are at the higher price end of the range.

If OTO-413 is released, these "better" hearing aids will become useless because no one is going to need the programs which supposedly help in noisy places. Thus people can just buy the basic hearing aids which only really amplify sound and are actually 50% or more cheaper than the premium devices.

This means that while OTO-413 or any synapse treatment will make hearing aids work better, it will also mean you won't need an expensive hearing aid with extra features either. Hence hearing aid manufacturers may find their profits plunge with an effective synapse treatment.

 

[weab00]

I have commented about this before but hearing aid companies would probably have concerns with OTO-413. Hearing aids are available with programs which supposedly help with hearing speech in background noise. These hearing aids are at the higher price end of the range.

If OTO-413 is released, these "better" hearing aids will become useless because no one is going to need the programs which supposedly help in noisy places. Thus people can just buy the basic hearing aids which only really amplify sound and are actually 50% or more cheaper than the premium devices.

This means that while OTO-413 or any synapse treatment will make hearing aids work better, it will also mean you won't need an expensive hearing aid with extra features either. Hence hearing aid manufacturers may find their profits plunge with an effective synapse treatment.

Wonder if they'll just raise the prices of standard hearing aids.

 

[Jack V]

I have commented about this before but hearing aid companies would probably have concerns with OTO-413. Hearing aids are available with programs which supposedly help with hearing speech in background noise. These hearing aids are at the higher price end of the range.

If OTO-413 is released, these "better" hearing aids will become useless because no one is going to need the programs which supposedly help in noisy places. Thus people can just buy the basic hearing aids which only really amplify sound and are actually 50% or more cheaper than the premium devices.

This means that while OTO-413 or any synapse treatment will make hearing aids work better, it will also mean you won't need an expensive hearing aid with extra features either. Hence hearing aid manufacturers may find their profits plunge with an effective synapse treatment.

While regenerative medicine could impact overall sales, something tells me, of the devices they do sell, they'll continue to find ways to justify high prices.

 

[Jack V]

Long term.

You might be thinking of OTO-313 which is for acute cases.

Not to go off topic, but I'm not sure OTO-313 is strictly for acute cases. My understanding is that they're still researching that.