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One question that needs to be asked is how long is the trial going to be in terms of duration. Another question is how long is Sound Pharmaceuticals going to take to prepare and deal with the results. Once this is proposed and we have been provided with this detail, we can then examine when it...

Yes, they should have all the data by this date.

SPI-1005 Treatment in Moderate COVID-19 Patients

This tends to be true. There is definitely part of my tinnitus caused by TMJ and the symptoms you described are exactly what happens with me. It also could be a combination of all three treatments too :D

Yes I believe it is.

The question I have is when are they going to run their Phase 3 trial for Meniere’s? Getting this (successfully) completed means that the medicine is available for an ear indication and will then be available for patient use.

I think that the treatment of outer hair cells will provide beneficial outcomes which are also significant. I totally agree that FX-322 won’t do everything. Essentially we know that FX-322 won’t fix all the problems anyhow because it cannot regrow synapses which are missing from good hair cells...

My dad did get his hip done. Definitely doesn't have any issues with walking, with moving or any pain problems whatsoever and this was done almost 20 years ago. As a result I think that it is fairly reasonable to conclude that there totally could be a situation where if you correct an injury it...

Now nanoparticles are something that has been extensively looked into here too to treat a number of issues in the ears. Essentially I have heard how a few ENTs who are actually also involved in treatment development definitely believe that the treatment of the ear is possible but the drug...

I’d hope that the FDA don't allow it to get used through the fast track for COVID-19 only.

Does this therefore mean that in Sound Pharmaceuticals' hair cell treatment support cells can remain untouched and intact? Thus they do not get depleted when you get this treatment?

Are they investigating channel blockers?

Damage-sensing Nerve Cells in Inner Ear Send Messages to Brain This is an article actually about ATP leakage from the ear. Essentially this article also predates most of regenerative hearing medicine development and research, however I have a feeling that this tends to suggest that the...

I agree. Actually at first people will be trying treatments that come out to market first like SPI-1005 or PIPE-505 but then over time as more medicines make their way onto the market, people will obtain a better understanding of what treatments actually work best for their individual and...

This is explained exceptionally well and also easily better than how Hough Ear Institute have been explaining it lately lol.

Where is the evidence that Hough Ear Institute is treating inflammation, thanks? I thought that they were just treating the synapses?

I think that there would be a lot of benefit if Sound Pharmaceuticals came out and indicated what they are going to do with SPI-1005 going forward. I know that they are pretty busy with testing it for multiple indications and particularly for COVID-19 at the moment but it would be nice to know...

I agree and actually also believe Sound Pharmaceuticals is just really savvy and playing the FDA process to their benefit. I also see a high demand for this medicine in Australia too. There would be doctors definitely willing to prescribe it if it helped tinnitus. There would also be a high...

I think this point is valid. Let’s just say it takes a year to get a vaccine for COVID-19 and in that time SPI-1005 will provide treatment for this. Once a vaccine comes along, demand for SPI-1005 will probably reduce significantly. Therefore Sound Pharmaceuticals will want to continue selling...

I could be reading this incorrectly but I am wondering whether we will see this possibly available off label for the ear indication if the COVID-19 trial is successful. The COVID-19 indication will be much simpler and much quicker to get FDA approval for and I think Sound Pharmaceuticals can...

I hope and also think that this treatment will provide benefit with tinnitus and hyperacusis. However I still think that this treatment will be a relief medicine similar to when you use inflammation creams and ice on a muscle strain to calm things for example before actually treating the...

Yes I think it predominately does work to treat hyperacusis/tinnitus. Though there was some benefit offered for hearing loss too and it is apparently also the offical indication it is to be used for.

I don’t think that you would actually need to take this everyday to prevent setbacks though. I would actually assume you take this once and theoretically it should reduce symptoms and you wouldn’t need to take it again. I also think that the medicine which treats the underlying causes like...

There was the lab rat research trial for SPI-1005's tinnitus/hearing loss indication. This research apparently demonstrated fairly positive results as well. I actually believe that Sound Pharmaceuticals may utilise this report to indicate the treatment's benefit and effectiveness for...

Is it possible to preserve the support cells utilising this method or is it not? At this stage if it is going to remove those support cells and the method is effective I would consider using it. Otherwise I would happily take FX-322 or similar any day over this. Also looks like Hough Ear...

Found this when I was looking into SPI-5557 and its benefits and mechanism of action. If it is the case that this can be replicated in people like it has been done in rats, and to date we are actually well aware that there are a lot of similarities between rats and people as has been shown in...

Basically it is the license from the FDA to confirm clinical trials can commence for a particular medicine. It is where the FDA basically scrutinises and assesses the trial process and gives it the go ahead accordingly if it is something they are happy with.

I found this thing through a search. It seems Sound Pharmaceuticals are actually at the point of being able to lodge this, although I am not sure if it is delayed further due to the issues around COVID-19, or due to the fact that there have been big changes and developments in what happens...

No, not entirely. Essentially it can work to reduce other troubles like inflammation if you take a course of it. It can be used for multiple issues.

I don't disagree with your comment at all. Although I would say that the government is making allowances for these hearing treatments and also some of these other health treatments to get released as quickly as possible with their fast tracking and compassionate use provisions. I actually am...

See it wouldn't surprise me one bit if Sound Pharmaceuticals never actually completes the phase 3 for Meniere's, because they can use the COVID-19 component of this treatment to justify quicker release under the compassionate use allowance. At this stage, Sound Pharmaceuticals has had successful...

This is correct, however what Rinri Therapeutics is working on probably won’t help most people who have had hearing loss from synapse/hair cell damage and actually have functional nerve hearing currently. Consequently their treatment will not be beneficial for most of us and thus there will...

See I don’t think that there would be any problem with exploring this. However I do wonder whether an inflamed cochlear actually also contributes to the pain? Therefore I would be very interested in seeing the benefits of this treatment on this type of pain. Pray that this will get released soon.

Not something you would go see a doctor about?

This is reassuring and your treatment knowledge is first rate.

I absolutely agree with you that this is an individual/case by case scenario of how SPI-1005 benefits a patient. I do think there will be big benefits from SPI-1005 in many cases, even if it doesn't totally relieve someone's tinnitus for example. I would also be interested in seeing how well...

Interesting times ahead indeed.

Do you think this could mean that with this treatment and also one of the other synapse treatments the Hough pill might become redundant?

There is research indicating that it does help with noise induced hyperacusis and/or tinnitus. The thing is that you would obviously need to try it, although the evidence and the information suggests that noise induced issues would be treated with SPI-1005.

Yes, you are making more sense now. Not sure what the rules are for off-label prescriptions in America, however in Australia a medicine can only be prescribed by a doctor if it falls within their scope. So for example a GP could get away with prescribing a Viagra course for heart help (under the...

I reckon the major reason why it has taken so long to complete the required research and actual trials is because Sound Pharmaceuticals firstly want to get the treatment as good as they can possibly get it and secondly because they think that they have a winner treatment. The fact that this...

Ahh all good. Going by what you are saying, the rules for prescribing drugs are very different in America to what they are here in Australia. I wish it was that easy lol, although I am assuming a number of ear specialists will work with these sort of treatments and have no issues in prescribing...

I wonder whether the report they released recently on the inflammation from noise was a key publication and they now have the required evidence to proceed further with human trials? I still agree that the COVID-19 indication is surely going to assist in getting this released if it indeed has...

No idea yet. I actually am unaware where you are located and so cannot comment specifically about who could prescribe medicines. In Australia, an ENT (not a GP) would need to prescribe this since it is a specific ear treatment for something that is probably more specific than what a GP would...

Their website states that they are currently in phase 2 trials for noise induced hearing loss. Companies often complete research work for various side studies which test the medicine benefit while conducting clinical trials. Frequency Therapeutics is doing this with groups such as tinnitus...

I think that it would depend on the benefits shown for other indications. If it has passed phase 2 trials for Meniere's for example, I can see some doctors thinking that this is sufficient enough evidence and reason to be willing to prescribe it for tinnitus.

I don’t think that this medicine is available yet. I know that they had got positive results in the Meniere's phase 2 trials and I think that they jumped onto the COVID-19 stuff once they knew that it could be beneficial. I think that they would try and get this treatment out ASAP using...

I don’t disagree with this, although the reality seems to be one of these two options. If the cost of this treatment is inexpensive, it is fine, but if it is expensive, then obviously I agree with you it is not. Now this is why I am suggesting that it would be better if Sound Pharmaceuticals...

There are only two methods which could overcome the problems with correct diagnosis. The first is to trial treat so we take the medicine and see what happens. The second is that Sound Pharmaceuticals runs some kind of clinical trials to see what the benefits of the treatment are based off...

This looks really, really promising. This drug looks like it will have very good benefit but it has also seemingly gone under the radar. Right now I am thinking this will do a lot of good in conjunction with the other treatments.

No idea :) I will try to find out some meaningful details.

SPI-1005 is currently going through the phase 3 trial for one of its multiple uses (it is apparently suitable for respiratory issues like cystic fibrosis along with ear issues). Furthermore Sound Pharmaceuticals have discovered that SPI-1005 is looking like it's useful to help with the...

I have a funny feeling SPI-1005 will end up being the first drug available out of all the ones being worked on in the hearing space.

I believe your analysis is right. I also reckon it will be interesting to see what other outcomes we will get from SPI-1005 too. I think that it is quite amazing that we will be taking this drug for our ears, yet it is also slated to provide benefits for other issues like respiratory matters. I...

Obviously once the clinical trial results come out or people are trialed with this treatment then we should know what it is actually treating. I reckon that if this does treat inflammation, it would probably be wise to take it along with other treatments too. There is quite a reasonable...

Well with what I have seen so far from their dealings, I reckon that they are mainly focused on the other treatments, SPI-1005 and SPI-3005, which are being trialled now. I think that this is due to the fact that these cover conditions more broadly and also the fact that they are trialing...

I’d be interested in finding out further about their SPI-5557 which would be their hearing loss injection. I know at this stage they are yet to file the IND according to their progress but not sure where they are at with the treatment generally speaking.

That now makes much more sense, thanks. That means their SPI-5557 treatment is the regrowth one then.

OK so when Sound Pharmaceuticals states that they are treating hearing loss with this treatment, they are actually referring to associated inflammation issues and are not actually attempting regeneration like OTO-413 is, for example?

Ahh so it doesn’t assist regrowing stuff but it helps hearing. How does it intend to work with that then? Sorry science isn’t my strong point.