Sound Pharmaceuticals (SPI-5557 & SPI-1005)

They haven't released a detailed report beyond a summary that I know of.

 

You could pay a research lab now to make Ebselen if you are that desperate.

Otonomy also has a drug finishing up Phase 3 that is very promising for Meniere's vertigo attacks that should be out middle of 2021.

 

How much are they charging?

 

When results come out in April 2021, how soon can Ebselen be released?

 

There are thousands of labs, I imagine it varies a lot. I would also factor in buying extra and getting it tested by an outside lab, too.

The one lab I looked at (and cannot vouch for as it was just a Google search) would end up charging about $5k for the full 21 day course used in the trial.

 

$10,000-$20,000 for a month's dosing, going by the dosing Sound Pharmaceuticals did for the Meniere's trial.

 

That's much cheaper than what I could find. Can you post the the link to that lab?

 

Hopefully the government will push for it right away. I'm tired of this pain and living this half life.

 

I didn't save that particular link. Sorry.

 

Sound Pharmaceutical's Phase 3 clinical trial for Meniere's Disease will start next month. They will be looking at TFI as a secondary outcome measure.

SPI-1005 for the Treatment of Meniere's Disease (STOPMD-3)

 

First the positive OTO-414 results and now this, what a week. Hopefully it can come to market sometime in 2021.

 

One of the trial sites is at a university very close to me. If only I could fake Meniere's to get my hands on it. Ebselen is so close yet so far away; it's maddening!

 

I feel you on this. I live right by UCSF and would love to participate, but I don't have Meniere's.

 

Is this for people with noise-induced tinnitus as well?

Not Meniere's.

 

They are recruiting for acute noise-induced hearing loss now as a preventative.

As to whether, like in Meniere's, it would help more chronic cases, it is theoretical.

Read the thread.

 

Is it really plausible that this drug comes to market in 2021? It has to complete Phase 3 and go through the data analysis, and then we have to wait for the FDA approval.

 

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 might end up getting released.

We know that there tends to be a delay of 75 days or something between the time a company requests to submit a proposal with the FDA to do something like a new trial and when the FDA is required to respond by. Then there are the issues around manufacturing and distribution.

In short, seems entirely possible that SPI-1005 could get released next year if the treatment shows beneficial outcomes. However the question is around what is going on and what will inevitably happen with the processes to get the treatment out there if it is granted approval. At this stage we don't have enough information on this and a lot of this is going to depend upon what actually happens. There could be a real possibility that Sound Pharmaceuticals simply cannot get this done next year.

 

Depends on how the COVID-19 trial goes imo, if it’s approved for COVID-19 treatment, it should be approved next year.

 

I was just doing some research on Sound Pharmaceuticals and why they had not gone public yet. ANYWAY... Our guy Dr. Jonathan Kil (CEO) is in the comments of

this article hyping his work. Love his grit!

 

I love that he's commenting on some random internet entry.

 

I am too dumb to understand anything in that article. Can I get the ELI5 version?

 

It's a blog from 2017 basically describing how structurally different the drug is from most drugs and how it's difficult to test in a lab because you need reducing agents to produce an ideal environment to study the effects but the ones they were using were paradoxically inhibiting Ebselen's effects (in vitro pre clinical stuff, not in vivo).

The author then goes on to say, Ebselen has promise for so many things. If only it weren't so hard to test in a lab.

But that's not really the main point. The point is that Jonathan Kil (from Sound) chimes in in the comment section of the blog (good find @Bambam0) with the following:

"The Daichii ebselen stroke trials were probably the most advanced clinically, but were limited due to the sample size, the nature of that disease, and the approval of tPA in 1997. In addition, I thought you maybe interested in our ongoing clinical trials in sensorineural hearing loss and tinnitus with SPI-1005. We have completed a Phase 1 and Phase 2 in acute noise induced hearing loss which were highly successful. We are currently enrolling a Phase 1/2 in Meniere’s disease (hearing loss, tinnitus and vertigo) and preparing to enroll two ototoxicity studies involving chemotherapy or antibiotic receiving patients. In several different models of acute neurotologic injury, we and others have shown that ebselen is highly otoprotective through its action as a GPx1 mimic and inducer. This later effect is somewhat dependent upon Nrf2 activation. My feeling is that ebselen will find a home in diseases where decreases in GPx activity result in the establishment of acute injury and the progression to chronic disease and/or in specific organs where GPx is the dominant catalytic antioxidant enzyme such as the inner ear, retina, lung and some areas of the forebrain."

 

Did we ever figure out why they haven't advanced to Phase 3 for NIHL? It's been 6 years since their Phase 2 ended and in their press release, they reported positive results from it.

 

They are "not yet recruiting" for Phase 2b now (you can look it up on clinicaltrials.gov) and have been for years.

My speculation on this is that it would be very difficult (to near impossible) to recruit for this (noise-induced) study since it is a noise challenge to people with a history of NIHL and it is placebo controlled. Yeah, good luck. Better to try it off label.

 

This thing can't come soon enough. How long are we looking at until we can get this off-label?

 

Can't you buy 1 g of Ebselen on Alibaba for $245?

https://www.alibaba.com/product-det...offerlist.normal_offer.d_title.3b4f3681Gtqpl1

Or is SPI-1005 different?

 

I would get it tested first. Or better yet I would buy it from a certified US lab if I were going that route and still get it tested by an outside lab first.

You could be buying anything from Alibaba.

 

What facilities test Ebselen?

Also, what is the dosing for this stuff and how much would it wind up costing?

 

Here are the different doses they are using in trial:

https://clinicaltrials.gov/ct2/show/NCT02779192

Probably good to start with the lower dosing if you are going to do this.

You'd have to call around to find pricing. It varies a lot. It seems to be on average a lot more than Alibaba--which concerns me about their authenticity (though things from China generally cost a lot less).

My guess is it would be a few thousand from a US lab but nowhere near Hough Ear Institute Pill cost.

You could call toxicology labs at universities near you and see if they would test a sample for you.

 

@weab00 do you think Ebselen will be good for hyperacusis? If yes, why?