Sound Pharmaceuticals (SPI-5557 & SPI-1005)

Because it doesn't cause any hearing structures to regenerate.

Otherwise you would have to say drugs like Prednisone were "hearing regeneration drugs" because they sometimes improve hearing when given to certain patients.

 

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.

 

It helps with inflammation, which is a factor in Meniere's and acute noise induced hearing loss.

 

SPI-1005 is intended for Meniere's disease and that disease is known to be preceded by cochlear's hydrops, which is abnormally high pressure in the cochlea. Even though ENT docs just classify idiopathic hearing loss with vertigo as Meniere's, there is usually a consensus that Meniere is a severe progression of cochlea hydrops. So because of that, the logic is to treat any causes that results in high cochlea pressure. For certain reasons, this abnormal pressure interferes with hearing, but it does not mean that the hair cells itself are damaged or destroyed. It just interferes with hearing.

Hence, once you solve the underlying issue that causes the abnormal cochlea pressure, you restore hearing and other issues like balance. So the solution for this is not restoring hair cells, because they're not damaged, but restoring the cochlea pressure to stop the hearing dysfunction.

Here's a good video on cochlear hydrops that precede Meniere's:

Cochlear Hydrops

TLDR; Not all hearing disorders are a result of hair cell damage or death and so the treatment for these disorders do not involve in restoring hair cell.

 

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?

 

I believe they are treating hearing loss, or rather as FGG puts it as hearing interference, resulting from Meniere's except this hearing loss isn't from cochlear hair cell damage but rather from hydrops.

 

This treatment was originally tested for Meniere's which has an inflammatory component to it. Meniere's is associated with fluctuating hearing loss due to hydrops until later as the disease progresses (over years until end stage), when hair cells are destroyed. This addresses the stages of Meniere's before hair cells are lost and does not regenerate hair cells.

They are also now testing it on acute noise induced hearing loss because anti inflammatory treatment has a positive effect on this (one of the reasons steroids help acutely).

The drug may also be helpful in cases where people have other inflammatory conditions or have other reasons for continued inflammation but I'm not sure they will do additional trials so that might be another "trial treat" situation.

Nothing structurally is regenerated here. They are treating hearing loss due to certain conditions but not "regenerating" anything. Maybe this will help with terminology: hearing aids are considered a hearing loss treatment.

 

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

 

Personally, I would be hesitant to take an orally-delivered pharmaceutical like SPI-1005 for NIHL since there could be negative ramifications to cellular structure elsewhere in the body. Frequency Therapeutics theorizes that the human ear is locked away from the body as its own entity for purposes of treatment of hearing loss and should be treated locally as is the case with FX-322. However, Meniere's Disease is a terrible condition and hopefully it will be treated successfully in the not-to-distant future by whatever means and worthy of the risk factors.

 

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.

 

I'm very interested in that one also but they were supposed to file 2 years ago and there has been no update.

 

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 SPI-1005 for COVID-19, which would shift their focus.

From what I’ve seen they will eventually get around to SPI-5557 and have the funding, although I think they are quite a small company so they simply might be stretched for appropriate manpower to work on this.

 

SPI-1005 may be the next drug on the market for us to try?

For those with unexplained fluctuating tinnitus, is it safe to presume it's possibly caused by inflammation which this drug will address?

 

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 likelihood that people will have inflammation anyway and it seems that taking this would be no different to taking a pain killer medication like you are given before stitches.

 

I think this drug could be very beneficial. We know its primary aim is to target Ménière’s, but I believe many of us here may have a form of cochlear inflammation. Going off data from their previous trial, tinnitus severity was reduced for a good amount of participants.

I have an intense variation in tinnitus severity. It can range from a 4 to a 9/10. Some days it can be worse than that. Aside from structural damage, I believe I have significant inflammation inside my cochlea. If this drug can reduce these fluctuations, that would be huge for myself and many others. It’s more potent than painkiller medication. I’m all eyes on SPI-1005. This can be a big breakthrough in tackling some cases of tinnitus.

 

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 know that this treatment is safe (because otherwise it wouldn't have passed safety trials), however I hope that the overlap in treatment scope doesn't result in some unknown adverse outcomes which delays the treatment's progression. This can happen, however from the limited information I have seen it appears to be fairly safe across the board.

 

What’s the drug’s timeline? It’s been 8 years since this post was made.

 

They are currently in phase 3 for Meniere's but are initiating a separate study for acute noise induced hearing damage. It should be able to be used off label after completion of phase 3 for Meniere's if they continue to show the great results they got in earlier studies.

 

Ye its always scary when you realize the thread was created ages ago

 

They got the green light from the FDA to initiate Phase 3. However, I’m not sure when it will begin or how long it will run. I wish it was available next year, but I don’t see it hitting the market until at least 2022 when you consider recruitment, trial length, analysis, FDA approval, and manufacturing. I hope everything runs smoothly, and it’s out as soon as possible. I have high hopes for this drug.

 

Since they're trialing SPI-1005 for moderate and severe COVID-19 cases, it's pretty much as expedited as it can be. Would be great to get it out ASAP for off label use.

 

I forgot about that. That could really expedite things.

 

Acute? So it will only treat tinnitus/sound sensitivity <a year old? I’m too far gone for that. How does the treatment work?

 

An FDA trial is only for labelled indications. It doesn't mean it can't be used off label. But if your tinnitus doesn't have much of an inflammatory component, this particular drug isn't likely to be as helpful for you.

 

Ok cool because mine does. I have hyperacusis which makes my tinnitus very reactive to certain frequencies and gives me stabbing pain in and around my ears. Ever since the hyperacusis my tinnitus has been “electrical”, ears feel raw.

 

Don't be scared. 12 years is about what it takes to get a new drug approved by the FDA. Even a new band-aid takes 3-7 years.

 

Completely forgot about that. That is huge.

 

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.

 

Are they on track for it?

 

Why?