Sound Pharmaceuticals (SPI-5557 & SPI-1005)

With a fast track, how long do we think it'll take before this drug hits the market, if all goes well?

 

From what I read, a fast track shortens time of review post phase 3 from 10 months to 6 months and starts the review process before all parts of application are complete. So, soon after phase 3 is complete, it sounds like to me.

 

I can't edit my previous post but i meant, on average. There is no set in stone review time, it's all case by case.

 

Your guess is as good as mine.

 

Interesting indeed. But I'm confused about something. Is the hearing loss associated with Meniere's different than than, I don't know how to put this, many other folks? I have sudden sensorineural hearing loss and tinnitus, and reading the press release, I don't see any mention of hair cells. I don't have Meniere's, apparently (multiple ENTs and such seem to agree) but the PR's mention of restoring hearing and reducing tinnitus obviously caught my attention. With an oral dose no less!

 

Going to add a clarification to this: I don't have the vertigo usually associated with Meniere's, though on occasion I've seen reference to "atypical Meniere's" without it. Nevertheless my team, including a super-duper research/cutting-edge ENT, concluded I don't have Meniere's. So I'm curious if this drug, if it pans out, is potentially another path to a cure or improvement for me.

 

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.

 

If their next trial (phase 3) goes well, the drug can be released to the public.

 

these drugs are for acute cases though right?

 

This is only for people with Meniere's? If it helps reduce tinnitus, shouldn't it help us with noise induced tinnitus?

 

It seems like it might but it is not clear if it applies to chronic cases, too.

 

Let's hope for the best. Still got a lot of hope for Susan Shore because she told me it's for us with noise induced tinnitus.

 

Is there anyone following the release of this drug that could direct me to any resources that can explain the physical process by which E. hydrops / menieres causes low frequency hearing loss?

I have found quite a bit of literature available explaining inner hair cells, outer hair cells, synaptopathy, etc... and how these relate to age related or noise induced hearing loss, but despite a lot of searching - almost nothing related to E hydrops related hearing loss.

 

Per this paper, there are a ton of effects starting from early (OHC) to intermediate (fibroblasts) to late (Spiral ganglion neurons-though i would be careful correlating animal studies here since their spiral ganglion neurons are different):

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923478/

 

So to sum up and resume, regarding NIHL (not Meniere), Sound Pharmaceuticals:

- did a phase 2 clinical trial with SPI-1005 for Prevention of Temporary Auditory Threshold Shift with healthy subjects
https://clinicaltrials.gov/ct2/show/NCT01444846
and the results were good (see attached file),

- are currently leading a phase 2b clinical trial with SPI-1005 to Prevent Acute Noise Induced Hearing Loss with Subjects with a History of either recreational and/or occupational exposure to noise and volunteering to be exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
https://clinicaltrials.gov/ct2/show/NCT02779192

 

I'm sorry, but who gives a fuck about a drug to prevent NIHL? They're called ear plugs. Give me a drug that treats this madness.

 

To administer this emergency treatment for people who have suffered an unforeseeable and irresistible acoustic trauma: exploding tire, airbags...

 

I see. I'm clearly no scientist, but if they know how to prevent it with a mechanism, then they'd probably know how to identify it and combat it for current sufferers like myself I would think.

Let's just hope a cure is on the way.

 

Sound Pharma advances pivotal Phase 3 clinical trials in Meniere's Disease

Sound Pharmaceuticals is pleased to announce that the FDA has allowed its pivotal Phase 3 clinical protocol for SPI-1005 in the Treatment of Patients with Meniere's Disease (STOPMD-3). This is the first Phase 3 study of an investigational new drug for the treatment of Meniere's Disease (MD), a neurotologic disease involving hearing loss, tinnitus, and dizziness.

..... Additionally, SPI-1005 treatment reduced tinnitus perception or tinnitus loudness (TL) by a statistically significant difference (p-value <0.05 using Fisher's Exact test) when compared to placebo. Reductions in TL averaged 1.4 pts in the 400 mg group vs 0.7 pts in the placebo group (30% reduction vs 10% reduction, p<0.02). These Phase 2b data confirmed an initial finding of the Phase 1b data, that SPI-1005 can reduce tinnitus loudness by clinically relevant levels. These improvements in auditory function further support the use of SPI-1005 to treat sudden hearing loss, noise-induced hearing loss, and age-related loss where sensorineural hearing loss and tinnitus are prominent features.


Link:
https://www.dailyrecordnews.com/new...cle_8b3f0f38-66f6-5b82-85f3-0904c7164343.html

 

"These improvements in auditory function further support the use of SPI-1005 to treat sudden hearing loss, noise-induced hearing loss, and age-related loss where sensorineural hearing loss and tinnitus are prominent features."

So is this only for Meniere's disease related tinnitus? Or can this be used for any kind of tinnitus? I'm not informed about this drug and the pharma behind it? Because in other post I read about acute stages only or perhaps only affecting lower frequencies?

 

The trial is for Meniere's but it appears useful for treating the inflammatory component of many etiologies. So might be a good drug to try off label especially since it seems safe.

 

Not sure if this drug can help non-Meniere’s sufferers also, but Sound Pharmaceuticals does have treatments in the pipeline for hearing loss and tinnitus. Per my discussion with CEO and Chief Medical Officer, Jonathan Kil:

“Yes we have four active INDs in hearing loss and tinnitus indication. In addition, we are measuring hearing function in the non-Meniere's ear especially at higher frequencies”

 

So let me use my brain. It says:
-sudden hearing loss
-noise-induced hearing loss
-age-related loss where sensorineural hearing loss and tinnitus are prominent features

So this would mean that it's not only for acute stages ?

 

Age-related is never acute so I came to the same conclusion.

 

“SPI-1005 is given orally and is being tested in several neurotologic indications including noise induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness or vertigo): due to aminoglycoside antibiotics (such as tobramycin) and due to platinum-based chemotherapy.“

It’s some sort of anti-inflammatory drug that’s replacing a molecule that they have figured out is depeleted in a damaged inner ear. Sounds like it could work for everybody. Exciting to see.

 

Oh wow, this sounds like it could work if your hearing issues are due to underlying cochlear inflammation, and could also tide us over until the Hough pill comes along.

My reactive tinnitus/hyperacusis could very well have an inflammatory component so I’ll definitely be keeping a very close eye on this until it releases.

 

I was thinking that as well, but I can't find anything about the possible side-effects. I (or anyone in that matter) don't want to ruin any changes for FX-322. If it depletes supportings cells like you mentioned audion's drug did then it's better to wait.

I saw this statement "No serious adverse events occurred, and the majority of adverse events were mild to moderate, and consistent with those observed in prior studies." But have no clue what the adverse advents are.

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

 

But why wait? I can't find anywhere if they are open for expanded access.

 

If they don't have a statement precluding expanded access, you could apply with your doctor. Who knows, they could grant it.

But it may be worth contacting the company to see what their policy is.

 

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!)