Sound Pharmaceuticals (SPI-5557 & SPI-1005)

[FGG]

I think I'm (personally) more excited about this than I am FX-322. I'd love to see if I can get in to that 3rd phase trial.


(Totally unrelated question, is there a way to direct message other members on here? If so could someone DM me and tell me how to do it. Thanks!)

https://clinicaltrials.gov/ct2/show/NCT02779192?term=Sound+pharmaceuticals&draw=2&rank=2

Looks like they haven't posted the Meniere's continuation study but here is separate one they are doing for NIHL. It's a bit sketchy though as they actually induce a noise challenge in people who have prior NIHL.

 

[BBakkers]

https://clinicaltrials.gov/ct2/show/NCT02779192?term=Sound+pharmaceuticals&draw=2&rank=2

Looks like they haven't posted the Meniere's continuation study but here is separate one they are doing for NIHL. It's a bit sketchy though as they actually induce a noise challenge in people who have prior NIHL.

Oeff sketchy indeed, they need some brave clinical trial participants for that

 

[BBakkers]

For whom it may be interesting. I took some steps to find out their stance on Expanded Access/Compassionate Use possibilities. I can update if anyone is interested. See the email down below:


Dear to whom it may concern,

myTomorrows is a company that helps patients with an unmet medical need and their physicians find and get access to treatment options. We facilitate the search and enrolment into trials and Expanded Access Programs, some of which we manage ourselves.

Recently I have been in contact with Mike ..... (in CC) who has been suffering from Tinnitus. He is extremely pro-active in his search to treatment options and came across the Phase 1/2b CT with SPI-1005. Although the indication is Meniere's disease, tinnitus is a sub-feature that was significantly reduced according to the recent news release with clinical findings.

I am inquiring on his behalf about Expanded Access/Compassionate Use possibilities and are curious about Sound Pharmaceuticals' policy regarding this.

Any information would be greatly appreciated.

Kind regards,

..................

Patient Navigator

 

[Emgee]

I've also reached out to the company regarding their stance on expanded access. This may be a helpful drug due to its safety profile and effectiveness on inflammation. 30% reduction in tinnitus loudness for the 400 mg group? This seems to be worth a shot. This is exciting.

 

[serendipity1996]

I've also reached out to the company regarding their stance on expanded access. This may be a helpful drug due to its safety profile and effectiveness on inflammation. 30% reduction in tinnitus loudness for the 400 mg group? This seems to be worth a shot. This is exciting.

I'd be very interested whether this could also potentially reduce hyperacusis-related inflammation.

 

[BBakkers]

I have emailed two times and called them once leaving a message. No reaction so far. No answer yet, ofcourse.

But don't you worry I'm going to stalk them until I get an answer. I don't really give a S...

 

[Emgee]

I was thinking about this. Should there be a difference in tinnitus effectiveness if a person doesn't have Ménière's Disease?

Tinnitus is tinnitus, right? Ménière's Disease does damage to the inner ear causing hearing loss which influences tinnitus prevalence. I would think the effect on tinnitus would have a shot at working for all tinnitus sufferers (providing the drug does indeed help). Which, it looks like it does.

 

[HootOwl]

I was thinking about this. Should there be a difference in tinnitus effectiveness if a person doesn't have Ménière's Disease?

Tinnitus is tinnitus, right? Ménière's Disease does damage to the inner ear causing hearing loss which influences tinnitus prevalence. I would think the effect on tinnitus would have a shot at working for all tinnitus sufferers (providing the drug does indeed help). Which, it looks like it does.

Meniere's is a tad bit different, because it has more to do with excessive endolymph produced by the stria, than structural damage.

For many Meniere's suffers their tinnitus and hearing loss/distortions fluctuate according to whether or not the stria is behaving normally. Over time though you can get damage to the hair cells if the swelling isn't controlled.

BUT, what's interesting is that there can be a strong viral component underlying Meniere's, which studies by Richard Gacek have demonstrated. So if you get the viral inflammation under control, you get the Meniere's under control. Thanks to @FGG for tipping me off to this. He basically took a group of people who had been diagnosed with Meniere's - didn't even bother with subtyping - and said "hey, let's throw antivirals at you and see what happens."

A group of people 1-2 years out from diagnosis got actual positive audiogram changes on his regiment, which is actually kind of incredible. Some didn't, but again, Gacek wasn't really concerned with subtyping. Their problem might not have been viral, or the virus had already done too much structural damage.

Most importantly though, he was trying to show that the inner ear can be highly susceptible to viral infections, resulting in inflammation that can generate some pretty nasty hearing symptoms.

So if your tinnitus is generated by viral inflammation - or any inflammation outside of maybe autoimmune -then this could be seriously helpful. Tinnitus from other factors, or actual cochlear damage? Probably not so much.

If it's autoimmune you would have to treat the underlying cause or possibly be on this stuff for life, which honestly given the safety profile might not be a huge deal.

 

[FGG]

Meniere's is a tad bit different, because it has more to do with excessive endolymph produced by the stria, than structural damage.

For many Meniere's suffers their tinnitus and hearing loss/distortions fluctuate according to whether or not the stria is behaving normally. Over time though you can get damage to the hair cells if the swelling isn't controlled.

BUT, what's interesting is that there can be a strong viral component underlying Meniere's, which studies by Richard Gacek have demonstrated. So if you get the viral inflammation under control, you get the Meniere's under control. Thanks to @FGG for tipping me off to this. He basically took a group of people who had been diagnosed with Meniere's - didn't even bother with subtyping - and said "hey, let's throw antivirals at you and see what happens."

A group of people 1-2 years out from diagnosis got actual positive audiogram changes on his regiment, which is actually kind of incredible. Some didn't, but again, Gacek wasn't really concerned with subtyping. Their problem might not have been viral, or the virus had already done too much structural damage.

Most importantly though, he was trying to show that the inner ear can be highly susceptible to viral infections, resulting in inflammation that can generate some pretty nasty hearing symptoms.

So if your tinnitus is generated by viral inflammation - or any inflammation outside of maybe autoimmune -then this could be seriously helpful. Tinnitus from other factors, or actual cochlear damage? Probably not so much.

If it's autoimmune you would have to treat the underlying cause or possibly be on this stuff for life, which honestly given the safety profile might not be a huge deal.

I just wanted to clarify that true Meniere's might not be viral but it is frequently misdiagnosed. And many of these misdiagnoses can be etiologies like viruses.

 

[Pre55ure]

Meniere's is a tad bit different, because it has more to do with excessive endolymph produced by the stria, than structural damage.

For many Meniere's suffers their tinnitus and hearing loss/distortions fluctuate according to whether or not the stria is behaving normally. Over time though you can get damage to the hair cells if the swelling isn't controlled.

BUT, what's interesting is that there can be a strong viral component underlying Meniere's, which studies by Richard Gacek have demonstrated. So if you get the viral inflammation under control, you get the Meniere's under control. Thanks to @FGG for tipping me off to this. He basically took a group of people who had been diagnosed with Meniere's - didn't even bother with subtyping - and said "hey, let's throw antivirals at you and see what happens."

A group of people 1-2 years out from diagnosis got actual positive audiogram changes on his regiment, which is actually kind of incredible. Some didn't, but again, Gacek wasn't really concerned with subtyping. Their problem might not have been viral, or the virus had already done too much structural damage.

Most importantly though, he was trying to show that the inner ear can be highly susceptible to viral infections, resulting in inflammation that can generate some pretty nasty hearing symptoms.

So if your tinnitus is generated by viral inflammation - or any inflammation outside of maybe autoimmune -then this could be seriously helpful. Tinnitus from other factors, or actual cochlear damage? Probably not so much.

If it's autoimmune you would have to treat the underlying cause or possibly be on this stuff for life, which honestly given the safety profile might not be a huge deal.

Thanks for that info, I'm very interested in SPI-1005. I haven't been diagnosed with Meniere's - but I share a lot of the same symptoms (episodic intense tinnitus, fluctuating hearing loss).
The potential connection to viral inflammation is really interesting. Do you have a link where I could read more on that study?

The doctor who I am currently being treated by is of the opinion that Meniere's (or more specifically E. hydrops) is a symptom of a problem with the inner ear, but not causative (if that makes sense). He was telling me that in some research he was following (I think he might be involved in) - they had essentially been able to trigger the onset of Meniere's symptoms (and the resulting E hydrops) by stimulating the brains of mice to essentially have intense migraines. Certain migraines seem to be implicated in causing the blood vessels that supply the inner ear to constrict, cutting off the blood flow and causing bad stuff to happen. Intense enough and often enough and it can result in all sorts of different types of damage to the inner ear (Often resulting in E. hydrops and Meniere's symptoms).

Anyway, probably not relevant to SPI-1005. But just thought it was interesting to hear some different theories behind what can lead to Meniere's type symptoms.

 

[HootOwl]

Thanks for that info, I'm very interested in SPI-1005. I haven't been diagnosed with Meniere's - but I share a lot of the same symptoms (episodic intense tinnitus, fluctuating hearing loss).
The potential connection to viral inflammation is really interesting. Do you have a link where I could read more on that study?

The doctor who I am currently being treated by is of the opinion that Meniere's (or more specifically E. hydrops) is a symptom of a problem with the inner ear, but not causative (if that makes sense). He was telling me that in some research he was following (I think he might be involved in) - they had essentially been able to trigger the onset of Meniere's symptoms (and the resulting E hydrops) by stimulating the brains of mice to essentially have intense migraines. Certain migraines seem to be implicated in causing the blood vessels that supply the inner ear to constrict, cutting off the blood flow and causing bad stuff to happen. Intense enough and often enough and it can result in all sorts of different types of damage to the inner ear (Often resulting in E. hydrops and Meniere's symptoms).

Anyway, probably not relevant to SPI-1005. But just thought it was interesting to hear some different theories behind what can lead to Meniere's type symptoms.

No problem, here's a link to the study. It's behind a paywall unfortunately, but the abstract gives you the basic gist.

https://pubmed.ncbi.nlm.nih.gov/25940200/

 

[annV]

No problem, here's a link to the study. It's behind a paywall unfortunately, but the abstract gives you the basic gist.

https://pubmed.ncbi.nlm.nih.gov/25940200/

Do you have a link where I could read more on that study?

F*ck the paywall. I attached the full paper.

 

[HootOwl]

F*ck the paywall. I attached the full paper.

@annV comin' in hot!! Thank you!!

 

[Pre55ure]

Thank you both for posting that / informing me of that study.

 

[tommyd87]

I don't understand SPI-1005. is it just trying to treat Meniere's or is it inevitably able to treat a multitude of conditions?

I wonder because I have seen it listed for other conditions including cystic fibrosis and Cisplatin ototoxicity too.

Thus if we were to take it for Cisplatin ototoxicity and we were unaware we had Meniere's, would it work on both together at the same time then too, lol?

 

[Pre55ure]

This drug is an anti-inflammatory medicine and mitigates swelling in the inner ear, which is believed to cause Meniere's Disease symptoms, such as vertigo, fluctuating hearing loss and tinnitus.

They also believe it can prevent inner ear damage becoming permanent due to noise, SSHL, or ototoxicity in the acute stage. It won't restore dead hair cells.

The results of the trials showed good results in reducing tinnitus and increased low frequency hearing response in patients with Meniere's Disease.

It's not aiming to have the same type of effect that something like FX-322 is, but there are more conditions than just Meniere's that it can probably help with. It's probably not going to be useful/helpful to most people suffering from long term tinnitus.

 

[tommyd87]

The results of the trials showed good results in reducing tinnitus and increased low frequency hearing response in patients with Meniere's Disease.

It's not aiming to have the same type of effect that something like FX-322 is, but there are more conditions than just Meniere's that it can probably help with. It's probably not going to be useful/helpful to most people suffering from long term tinnitus.

If it is helpful and effective when it comes to dealing with low frequency hearing, then this treatment could be complementary to FX-322.

 

[Emgee]

https://www.prnewswire.com/news-rel...005-in-phase-2-covid-19-trials-301103291.html

"Sound Pharmaceuticals (SPI) is pleased to announce the filing of an Investigational New Drug Application with the FDA to begin Phase 2 studies to prevent and treat COVID-19."

"SPI-1005 is an investigational new drug that contains ebselen, a novel small molecule that mimics and induces the activity of Glutathione Peroxidase (GPx) in the inner ear, retina, brain, lung, and kidney. SPI-1005 represents a novel class of anti-inflammatory and is under clinical investigation in several neurotologic diseases where GPx activity is reduced including sensorineural hearing loss, tinnitus, ototoxicity, Meniere's disease, and neuropsychiatric illness including bipolar mania."

 

[FGG]

https://www.prnewswire.com/news-rel...005-in-phase-2-covid-19-trials-301103291.html

"Sound Pharmaceuticals (SPI) is pleased to announce the filing of an Investigational New Drug Application with the FDA to begin Phase 2 studies to prevent and treat COVID-19."

"SPI-1005 is an investigational new drug that contains ebselen, a novel small molecule that mimics and induces the activity of Glutathione Peroxidase (GPx) in the inner ear, retina, brain, lung, and kidney. SPI-1005 represents a novel class of anti-inflammatory and is under clinical investigation in several neurotologic diseases where GPx activity is reduced including sensorineural hearing loss, tinnitus, ototoxicity, Meniere's disease, and neuropsychiatric illness including bipolar mania."

Woah, interesting find.

 

[FGG]

If it is helpful and effective when it comes to dealing with low frequency hearing, then this treatment could be complementary to FX-322.

FYI, the low frequency hearing loss in Meniere's is due to hydrops and is not the same etiology as other causes.

 

[tommyd87]

FYI, the low frequency hearing loss in Meniere's is due to hydrops and is not the same etiology as other causes.

I understand this. However, I have read that there were improvements in low frequency hearing. This drug is seemingly being used for a multitude of conditions, including Ménière's, hearing loss and coronavirus being some of them. Or am I wrong?

 

[FGG]

I understand this. However, I have read that there were improvements in low frequency hearing. This drug is seemingly being used for a multitude of conditions, including Ménière's, hearing loss and coronavirus being some of them. Or am I wrong?

Oh, for sure it's being tested for multiple indications but the data quoted so far is specifically referring to improvements in low frequency hearing in Meniere's.

We won't know what frequencies (maybe some, maybe all) it improves in non Meniere's patients until more data comes out.

 

[tommyd87]

Oh, for sure it's being tested for multiple indications but the data quoted so far is specifically referring to improvements in low frequency hearing in Meniere's.

We won't know what frequencies (maybe some, maybe all) it improves in non Meniere's patients until more data comes out.

Ahh, that's what I thought.

What I am not sure about is if they are testing this treatment for Ménière's first because it is easier to get it approved for, and then can have it prescribed off-label for conditions like hearing loss.

Or if they are testing it first for Ménière's, and then they will move onto testing it for other conditions.

 

[FGG]

Ahh, that's what I thought.

What I am not sure about is if they are testing this treatment for Ménière's first because it is easier to get it approved for, and then can have it prescribed off-label for conditions like hearing loss.

Or if they are testing it first for Ménière's, and then they will move onto testing it for other conditions.

It's in between phase 2 and 3 for Meniere's. They are recruiting for a phase 2b for acute NIHL concurrently.

 

[tommyd87]

It's in between phase 2 and 3 for Meniere's. They are recruiting for a phase 2b for acute NIHL concurrently.

Ahh, cool cool. Can only hope that the more treatments investigated, the better chances we have at having success.

 

[Thuan]

@FGG Sound Pharma and Frequency Therapeutics' hair cell regeneration have similar mechanism of action (induce support cells to proliferate and then differentiate to hair cells). They both seem to be targeting different gene control protein. Or, are they just the same but named differently?

It's in between phase 2 and 3 for Meniere's. They are recruiting for a phase 2b for acute NIHL concurrently.

If they're recruiting for phase 2b, did they already release results for phase 2a?

 

[FGG]

@FGG Sound Pharma and Frequency Therapeutics' hair cell regeneration have similar mechanism of action (induce support cells to proliferate and then differentiate to hair cells). They both seem to be targeting different gene control protein. Or, are they just the same but named differently?

If they're recruiting for phase 2b, did they already release results for phase 2a?

Sound is not a hair cell regeneration platform with this drug. Their drug is induces glutathione peroxidase. It's essentially a powerful anti inflammatory for neuroimmune inflammation (Meniere's has a strong inflammatory component).

They didn't do an earlier phase for noise induced but they don't have to run a separate safety trial (phase 1) or for lack of a better term general efficacy dosing trial (phase 2a). They are starting on phase 2b for noise, using the Meniere's data.

Here are the Meniere's results:

https://soundpharma.com/soundpharma...005-phase-2b-menieres-disease-clinical-trial/

 

[Thuan]

Sound is not a hair cell regeneration platform with this drug. Their drug is induces glutathione peroxidase. It's essentially a powerful anti inflammatory for neuroimmune inflammation (Meniere's has a strong inflammatory component).

They didn't do an earlier phase for noise induced but they don't have to run a separate safety trial (phase 1) or for lack of a better term general efficacy dosing trial (phase 2a). They are starting on phase 2b for noise, using the Meniere's data.

Here are the Meniere's results:

https://soundpharma.com/soundpharma...005-phase-2b-menieres-disease-clinical-trial/

So the current drugs by Sound Pharmaceuticals aren't listed under the Regeneration tech in their website (last section):

https://soundpharma.com/technology

That's a bummer.

 

[FGG]

So the current drugs by Sound Pharmaceuticals aren't listed under the Regeneration tech in their website (last section):

https://soundpharma.com/technology

That's a bummer.

Correct.

 

[tommyd87]

Correct.

Is there a reason that you can point me towards as to why SPI-1005 doesn't fall under hearing regeneration? Right now I know that they are investigating and working on other categories which will be targeting hearing regeneration directly and solely.

Is it due to the fact that this treatment is seeking to treat a multitude of conditions and thus doesn't exclusively fit the category of hearing regeneration? Thanks.