Sound Pharmaceuticals (SPI-5557 & SPI-1005)

Does anyone know if SPI-1005 will be made available first as a COVID-19 drug or will the STOPMD-3 trial be done first?

The COVID-19 trials have a priority/urgency but I don't know how well Ebselen will do in them. On the other hand, Phase 3 for Meniere's isn't even recruiting.

 

Will Ebselen be effective for chronic tinnitus caused by reasons other than Meniere's disease?

 

They actually are recruiting at some of the trial sites according to Jonathan Kil at Sound Pharmaceuticals. I believe the Michigan test site completed recruitment according to some of the other members here. If there's a test site you're interested in, I would reach out to Sound Pharmaceuticals to see if they're recruiting.

 

My thought:

I would guess it would be highly individual and depend on how much neuro inflammation you have.

I think there is a good chance it will at least help people with cochlear causes but the degree will vary a lot imo from minor to game changing.

I don't think it will do much for middle ear, TMJ tinnitis etc, though.

 

That is great news! Hopefully they can start the trial ASAP; I'd love to try it out but I don't have Meniere's nor am I US based.

 

Does anyone know if SPI-1005 trial for COVID-19 has started yet?

I thought it was supposed to start in December but the status says “not yet recruiting”.

I was hoping this drug could make it to market pretty fast due to COVID-19 emergency, and that we might then be able to put our hands on it for off-label use.

Do you guys think there is a chance?

I am not even sure whether SPI-1005 could help with tinnitus tbh, but I desperately need a hope to look forward to in the near future, rather than years. The other drugs on trials are taking too long with all these delays, failures, repeated trials etc.

 

They haven't listed locations yet on clinicaltrials.gov for the COVID-19 trial, so they definitely haven't started recruiting yet.

They listed these contact names for the COVID-19 trial:

Miriam Treggiari and Haifan Lin. Both out of Yale. Maybe someone can shoot them a line and ask where they are on recruitment?

 

I just found this paper about the clinical trial of SPI-1005 where they evaluated its efficacy for preventing NIHL:

Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial

Interestingly, the 600 mg group showed far less efficacy than the 400 mg group and performed even worse than the 200 mg group. Not sure though, what kind of conclusions I should draw from this. Any ideas @FGG, @Diesel?

Also, does anybody know the bioavailability of Ebselen? It would be interesting to know what 400 mg BID orally taken corresponds to in the end.

 

Their current otoprotection trial is here:

A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

And they don't include a 600 mg cohort. Seems there is an efficacy sweet spot, which wouldn't be too bizarre since its effects are indirect and on things like enzyme redux reactions in the cochlea. The conclusion I would draw is that 400 mg seems like the best dosing but they are retesting that with the current trial as far as the exact biochemical reason, you'd have to find a published paper and I'm not sure they have done that yet.

 

This is amazing news, and I’ve submitted a couple questions. I really, really hope that there is a focus on how this medication could help hyperacusis and how urgently it is needed by those of us who are suffering from it. It truly could save lives if it helps.

 

Sound Pharmaceuticals agreeing to come on the Tinnitus Talk Podcast is a sign of confidence in their drug, which should be available late this year or early 2022.

 

I'd love for this medication to be available as soon as possible, but I fear it won't be available until sometime in 2023 because the Phase 3 Meniere's trials don't end until December 2022.

Have you seen other information that gives you an earlier release date?

 

The COVID-19 trials. The FDA is giving the OK to anything related to COVID-19.

 

They haven’t even started recruiting for COVID-19 trial yet; who knows when/if they’re going to move forward with it.

 

I struggle to know what to ask about any treatment other than FX-322, because even after perusing the threads, it's murky to me what they specifically do, or are intended to do. I'd like to have more than one horse to bet on in this race, but I need a clearer and more concise description of what each treatment does (e.g. "FX-322 reactivates the cells that normally only produce hair cells while we are in the womb, and in its current delivery method seems to only help with high frequencies due to how far it reaches into the cochlea."); I've been unable to find this sort of Cliff's Notes-style summation for the majority of drugs being tested and discussed.

 

Does anybody know the approximate bioavailability of Ebselen when taken orally? I've skimmed many papers about Ebselen but so far I could not find any statement in that regard.

 

Hey everyone.

I got my doctor to write a letter to Sound Pharmaceuticals asking for compassionate use of Ebselen and seeing if trials will be coming to Canada, as nothing seems to be working for my hyperacusis & tinnitus.

The e-mail was sent on Friday and hoping they will get back. Has anyone done this or thought about doing? Maybe if we can get enough doctors to write to Sound Pharmaceuticals we can get it sooner to possibly help us!

I will keep everyone updated through the process.

I am from Toronto, Ontario, Canada.

Cheers!

 

Please update us and if possible share what they say in their response. I think a lot of people would be interested in that. The drug should be available in 2022.

 

You are the real MVP. I hope it comes through for you.

 

I will definitely update. I sent them a personal email a few months ago with no response, so I am hoping that they get back to my physician at least. If they don't, next step is to get my physician to call them.

Do you really think it will be available in 2022? And worldwide?

Hoping so too, thank you!

 

I don't want to be a big party pooper. But I did the same as you. Asking for compassionate use. Emailed them 3 times. Called 5 times. Let my doctor email 2 times. I never ever received one single response. So don't get your hopes up.

"Boosting up the habutation "

 

There’s always Alibaba.com, and I’m close to being that desperate. I haven’t been able to find any other suppliers to either respond or that were affordable. I live in a major city, and my friend in biotech hasn’t been able to find a manufacturer in our area to make it, either.

I was quoted $1,250 for 15 grams from Wuhan Hengheda PharmCo using the Alibaba app. I know it would need to be tested by a third party, though.

 

Looks like Ebselen is the last man standing.

 

There’s still the Kv7 drugs like XEN-1101 and the Trobalt reformulation. Also Nav1.7 blockers, they seem far away but there’s a lot of money going into them. But yes, generally speaking we remain fucked beyond belief.

 

Seeing as our joint flight to the US to get FX-322 is probably canceled for now, could you give me the rundown on SPI-1005?

I've read they've seen improvements in perceived Tinnitus in Meniere's patients—but what about non-Meniere's patients?

Also, how did you get a Dutch doctor (I'm assuming your huisarts) to e-mail them? I usually have a hard time convincing mine to do much of anything for me, really.

 

I’m starting to understand where the pessimism of tinnitus veterans comes from.

 

This company has a promising Nav1.7 blocker in pre-clinical. Seems roughly where the Trobolt reformulation is since they are starting to be talked about in biotech circuits:

Tackling the Opioid Epidemic with a Novel Gene Therapy for Chronic Pain

 

It says it's for chronic pain. Would it work for tinnitus as well?

 

Thank you for sharing!

Ah! I see they are in SoCal. Maybe I can volunteer to be one of their lab rats...