Sound Pharmaceuticals (SPI-5557 & SPI-1005)

What's a realistic timeframe for the first version of SPI-1005 to come out? 2022?

 

More like 2023 IIRC.

 

Phase 3 for Meniere's (ends 2023).
Phase 2 for COVID-19 (ends 2022).

They would have to skip Phase 3 for COVID-19 for it to come out 2022. It's possible but 2023 could be more likely.

 

How come the Phase 2 trial for COVID-19 ends in 2022? I thought with the urgency they could do all Phases within a year for COVID-19?

 

Someone suggested that possibility because of the vaccines and a few other COVID-19 treatments. It doesn't look like that's a blanket policy though. The clinicaltrials.gov page lists the trials and their time courses.

 

Hopefully if Phase 2 results look good, they can skip Phase 3 but I don’t think that will be happening.

I guess it will be 2023 then.

 

It's a very real possibility. Auris Medical is going to launch a product this June in Europe for COVID-19.

Auris Medical Announces Positive Preclinical and Clinical Outcomes with AM-301 and Details Plans for Market Launch

If it does well, they could use that capital to fund their entire pipeline.

 

I really don't want to sound mean, but somehow I'm grateful for the COVID-19 pandemic because I hope that with tinnitus as a long COVID-19 symptom, tinnitus research will also receive more research funding.

 

Well I agree with you. It sucks that this had to happen for so many people but I'm sure that with enough of us + veterans + COVID-19 people, money will start pouring in.

 

Believe me, you're not the only one who feels this way. The more people who are affected, the better our cause.

 

COVID-19 is the AIDS of the XXIst Century, the medical community + pharma is going to obsess over everything related with COVID-19 for decades to come. And since tinnitus seems to be a somewhat common side effect of it, let's just say this bodes very well for us.

 

I'm late to this thread. Could anyone please explain me the mode of action (and likelihood of efficacy) of this drug for tinnitus?

 

Yeah it’ll be interesting to see the long-term data from both COVID-19 infections and vaccination side effects. Right now it seems like a lot of the data is not well compiled. So, I would suspect by this time in 2022, there will be better analysis of the long term issues that need attention. I also don’t think COVID-19 is going anywhere, it will be the new “flu” where annual vaccines and treatments will be common place.

Do I hope hearing loss and tinnitus gain new attention and investment as a result of COVID-19 long term outcomes? Yes.

 

Another thing to consider is how well off HIV/AIDS patient are now, in less than 3 decades they got rid of most if not all of their symptoms, now it isn't a death sentence. They can live long happy lives, have children, enjoy everything. There are even trials right now for a "cure".

And they started from scratch. We have tons of data and several companies are even on trials or about to be.

Also they had to fight the medical establishment that was severely discriminating them, on the other hand we are going to be considered victims of the greatest tragedy of the century.

Everyone is going to try to help us!

 

I think it speaks volumes that most of us would gladly settle for a 30 or 40% reduction from a drug not even originally intended for tinnitus just for a QoL improvement.

I get brief decreases in my tinnitus when I take Klonopin for panic attacks and that decrease alone is practically worth having a panic attack for.

 

When Ebselen is out, I'm going to pop it like House did Vicodin.

 

I take a comedically small dose of Klonopin and I told my counselor I was gonna carry a bottle of half pills around and approach every woman as Lisa Cuddy all the while popping little crescent pills.

I'll join you for the Ebselen.

 

Don’t forget FX-322. That will probably come out first before Ebselen.

 

I believe wholeheartedly in PCA and FX-322, however this last trial made us realize it isn't going to be a smooth ride.

I seriously don't know if that timeline is realistic. They will get it eventually. The better question is when...

 

I seriously doubt FX-322 will be out by 2023, assuming it comes out at all.

 

I read that Ebselen was successful at eliminating tinnitus on animals.

But can someone tell me how do scientists know whether, for example, a mouse has tinnitus or not? Or that whether the medication has helped to alleviate its tinnitus or not?

I presume they don't ask the mouse "hey do you have tinnitus now"? So how do they find out then?

And I am also surprised and a bit sad that even animals get tinnitus However, if they help in research of human tinnitus cure, then I respect them.

 

You condition the animal to do a certain behaviour when hearing sounds. For example the animal gets electric shocks shortly after a sound is played, or the animals get food at a certain spot while playing a sound. After one induced noise to the animals, they will behave different to the control group of animals without tinnitus.

Can you post the link about the animal study? The only proof of Ebselen helping tinnitus I know of are the clinical trials about Meniere's disease, where it reduced tinnitus perception by up to 30%.

 

I read that Ebselen is an anti-inflammatory, is that right?

My concern with this molecule is that many anti-inflammatories make tinnitus worse permanently.

I experienced this 6 months ago; I took an anti-inflammatory for 6 days for foot pain, and my tinnitus has been so intense since then that I can hear it over my tinnitus masker...

 

You probably took an NSAID which are known to cause tinnitus in some people. Just "fighting inflammation" isn't what's causing those effects. Both Fish Oil and Advil, for example, act on the pink arm of this diagram and Fish Oil isn't known to cause tinnitus:



Ebselen reduces the effects of TNF-alpha (cytokine as part of the yellow cascade in the drawing) as well as dampens glutamate related neuro excitability. It has a lot of other effects, too. It's a complex drug.

 

Does SPI-1005 treat visual snow caused by previous cochlear damage?

I read that it reduces the neuro-inflammation, then it could reduce some of the central hyperexcitability? Visual snow bothers me more than tinnitus, especially in the dark.

Thanks.

 

I had the same question, though visual snow doesn't bother me nearly as much as my ear stuff.

We might have to wait until enough VS peeps try it and report back but, off hand, it seems potentially helpful for VS.

 

Looks like Asia is very interested in Ebselen, especially India and Taiwan. I wonder if they can put it to market before Sound Pharmaceuticals...

They're combining it with other drugs to boost the effects against COVID-19. They're already doing it in Taiwan and India is about to. Not only that, type "Ebselen" into Twitter, search by latest and you'll find a plethora of researchers finding uses for it.

 

I did a Twitter search and found a lot of recent write ups but nothing about what they are doing in Taiwan and India. Do you have a link?

 

CORONAVIRUS/Taiwanese researchers suggest new treatment for COVID-19: study

When I said "already doing it," I meant playing with it and testing it in the lab. I speculated about them coming first because maybe their FDA are less anal?

Also, Indian medical accounts are talking about using Ebselen too. Some mentioned they make/can make Ebselen in India so they could mass produce it for their recent, and tragic, second wave.