SPI-1005 Enters Phase 3 Trials, on fast track with FDA - Sept. 2019

Hallelujah! I hope it comes very soon. Thank God!
Inday

 

Awesome. Thanks for posting this.

 

Sound Pharma put out a press release last week announcing that the FDA has allowed a Phase 3 trial to proceed. Not a lot of detail here about the timeline, and nothing new on their website, but it looks like they now haver permission to go forward with Phase 3. Sound Pharma advances pivotal Phase 3 clinical trials in Meniere's Disease

 

Thank you for bringing a little more hope. The only thing that worries me about that press release and if I have not misunderstood it (I do not speak English) is that they do not give any information about the improvement of dizziness / vertigo.

Now it's time to wait, it's a shame that clinical trials take so long, a phase 3 can take from 18 months to 3 years or more. I understand that it is for safety, but you compare it with the coronavirus vaccine that in 5 months is already being tested in humans to be able to manufacture it by the end of the year. In other words, in 10 months they will have carried out the three clinical phases of several different vaccines, sometimes I would like meniere to be as contagious as covid, in a year we would all be cured. ¬ ¬

 

By mimicking the actions of glutathione peroxidases, ebselen (SPI-1005) functions as a reducing agent that protects ophthalmic and otological structures from oxidative damage. Dysregulation of the oxidative stress response is a hallmark of MD pathology.

Meniere disease and ebselen: anti-neoplastic may help manage symptoms

With every day searches in the scientific literature I found more and more sayings that oxidative damage can cause MD.

With this in mind I already started taking various antioxidants to prevent further inner ears degenerative processes.

 

Thanks for posting this. Fingers crossed and prayers up for a success. Yes, trials take some time, but the thought that it could materialize in the future keeps my hopes alive!

 

Well that’s very interesting finding! We all impatiently are waiting for SPI-1005 (Ebselen) to be approved by FDA to treat MD symptoms, but maybe NOW the solution is already available and it’s cheap and available, unlike Ebselen, also safe and you don’t need the prescription!

So what I had found in the internet:

SPI-1005 (Ebselen) mimics and induces glutathione peroxidase. NAC is also glutathione precursor.

Ebselen and NAC, both potentiate the glutathione peroxidase pathway. These two compounds were capable of increasing endothelial glutathione levels.

This efficient mechanism of action allows SPI-1005 (Ebselen) to work at low oral doses, unlike antioxidants such as n-acetylcysteine (NAC).

Both SPI-1005 (Ebselen) and NAC protects ophthalmic and otological structures from oxidative damage.

So, if I am right, SPI-1005 and NAC works in very similar ways. Only SPI-1005 (Ebselen) is more efficient and needed low oral doses to reach the effect comparing with NAC.

What are your thoughts?

 

I currently take NAC, but do you know how much needs to be taken in order to be effective?

 

Well in this trial they are using 400 mg daily doses of SPI-1005 (Ebselen). So NAC doses should be several times bigger according to the info above.

Also I had found in this forum that one member were using 2-4 grams of NAC daily.

So my suggestion, start from 1 or 2 grams daily and later on you can increase gradually till 4 grams.

Do your own experiment to see what dose is best for you.

 

What is NAC?

 

N-Acetyl-L-Cysteine

 

What else I did find on the Internet about NAC doses:

At higher doses (≥1200mg), acetylcysteine also acts as an antioxidant through complex mechanisms which can combat conditions of oxidative stress.

 

NAC is acetylated amino acid. The mechanisms of NAC are only beginning to be understood, it is likely that NAC is exerting benefits beyond being a precursor to the antioxidant, glutathione, modulating glutamatergic, neurotropic and inflammatory pathways.

N-acetylcysteine is now widely used as a mucolytic and in the treatment of HIV, and it has reported efficacy in chronic obstructive pulmonary disease and contrast-induced nephropathy. Specific to brain disorders, NAC has been trialled with some efficacy in patients with Alzheimer disease.

NAC appears safe, tolerable and affordable.

 

Sounds interesting if what I'm testing now fails. Let's see if someone who has been testing it for several months can tell us something else.

 

I crossed this same NAC thought process upon researching Ebselen, and added NAC to my regimen several months ago because of this. I also added a few other anti-oxidants (grapeseed extract, pine bark extract, turmeric, selenium) and re-introduced L-Lysine so hard to say what has produced my favorable results. I will say my vertigo is more under control now than its ever been. It is is so minor and infrequent that I often forget about it (unless I get into a moving vehicle) -- it is usually a 0-3 on a 10 point scale. The fluctuating tinnitus is still there, although quieter most of the time that I can forget about it when concentrating on tasks.

I've spent a lot of time researching the correlation between oxidative stress and Meniere's, and I've wondered whether high oxidative stress in my body is the underlying cause of my Meniere's -- and whether this high oxidative stress environment has causes both inflammation and possibly also viruses to more easily attack my ear. I read a study that showed viruses thrive in conditions of high oxidative stress because the body's immune system is suppressed (eg due to glutathione being depleted). This is important because glutathione is not only the body's primary antioxidant but also has resultant antiviral activity. NAC is the limiting precursor to glutathione so taking NAC should boost glutathione levels (much more than taking glutathione supplement directly which is inconclusive if it works).

This is a great video on how the body uses Glutathione/NAC and how it relates to COVID. There is even a shotout to a study which mentions Meniere's Disease @ 12:17 which states:
"Asher and Guilford performed a review of the literature from 1980 to 2016 on the role that oxidative stress and GSH play in the ear, nose and throat (ENT) conditions. The authors concluded that many ENT conditions such as rhinitis, allergic rhinitis, chronic rhinosinusitis (CRS), CRS with polyps, otitis media with effusion, chronic otitis media (COM), COM and cholesteatoma, tympanic membrane sclerosis, tonsillitis, Meniere disease, laryngeal conditions, and chronic cough are associated with oxidative stress and decreased GSH, both locally in the affected tissues and systemically. They also suggested that the oxidative stress related to those conditions may be due to depletion of GSH"

The question that has been on my mind is, which came first... the viral load or the high oxidative stress environment?

 

Nice to hear someone thinking similarly! I am also taking grape seed and pine bark extracts and also added medicinal mushrooms.

Which NAC doses are you taking?

 

If what I'm trying now doesn't work, I'll try it too. Meanwhile I will read your impressions, the dose you take, etc.

 

I have been taking 1000mg NAC, but have increased to 2000mg as a result of this discussion. I also see this 2g dosage effectively used in studies for other ailments.

What mushroom are you taking? I took 2g per day of Coriolus Versicolor (per this study) for 6 weeks. I can't comment if I saw any perceivable difference as there wasn't any "Aha!" moment. I did get a little stomach ache when I tried to do 3g for 30 days to mimic the study, so I reduced to 2g. Looking at that study's positive results again, it might not be a bad idea for me to do another round with Coriolus and try for that 3g dose.

On a related note, I saw someone else posted this but it looks like SPI-1005 (Ebselen) is being put to the test against COVID. The study is planned to be completed in December 2020. Googling "Ebselen COVID" brings up many results. This study here basically says Ebselen is antiviral, antioxidant, and antimicrobial (candida, and others). Another study says "Recent computational-experimental screenings have identified several existing drugs that could serve as effective inhibitors of the virus’ main protease, Mpro, which is involved in gene expression and replication."

Information like this adds to the argument of Meniere's being virus-related (and oxidative stress), and pushes me more toward getting a prescription anti-viral...

 

Very cool to hear!