A closer look at SPI-1005 (Ebselen) for Meniere's - how it works, trial data and expectations.

[00:00:00]Could an experimental drug that's currently in the final phases of testing be the miracle treatment that many airs patients have always looked for? Welcome to Many Airs Without the Spin.

[00:00:14]The drug cenamed SPI 105 from the US company Sound Pharmaceuticals has been in development for more than 10 years.

[00:00:22]So, I thought it was finally time to take a look. I've dug through the trial results and also looked at the anecdotal reports of people who've actually been on the trials. Bottom line, it looks like the drug might help people to a degree with hearing loss and tinitus, but is unlikely to have any impact on vertigo. It's not a miracle cure, but it may be a step towards managing some of the symptoms. But why might it help at all? The active ingredient of SPI 105, Epsilon, is a powerful antioxidant and is thought to work directly to prevent inner ear damage. Today, we're going to look at why an antioxidant might help, see what the latest trial data says, and talk about the timeline for when this drug might actually reach patients. So, let's get into it. When the inner ear is under attack from inflammation or excess fluid or any of the other many as triggers, it suffers so-called oxidative stress. This means that the cells are producing harmful waste products faster than the body can actually get rid of them. One of the main culprits here is hydrogen peroxide. These hydrogen peroxide molecules begin to build up and if they're left alone, they can damage the delicate hair cells and nerve endings that control your hearing and balance. As an example, we have the strivascularis on the inside wall of the coccleia. This layer of cells works incredibly hard to maintain the right balance of chemicals in the inner ear fluids. The result of all this hard work is high levels of hydrogen peroxide that could also do a lot of damage.

[00:02:08]Your body naturally produces an enzyme, a protein called glutathione peroxidase whose job is to deal with the hydrogen peroxide and other waste products. But during a severe many flare up, your body's natural defenses could get completely overwhelmed. This is where the drug comes in. Epsilon is a synthetic molecule that behaves a lot like the body's natural enzyme, but with the added benefit that it doesn't get used up the way the enzyme does. It helps to convert hydrogen peroxide to harmless water and oxygen and keeps on and on doing it. So, epsilon was thought to potentially protect the delicate hearing structures of the inner ear. and animal experiments seem to bear this out which eventually led to human trials in many patients. So what does the trial data actually show? Like all trials of new drugs, SPI 105 had to be compared with the dummy placebo drug. The interesting thing is that large numbers of patients seemed to see improvements on the placebo.

[00:03:19]So the drug itself has to do better than that if it's to in some sense be seen as working. And it did better than the placebo for more patients when it came to improving hearing in the low frequencies for recognizing words against a noisy background and also there was some improvement in tinitus. Vertigo however seemed not to be helped. There are many nuances to the trial data and for a more indepth look I wrote a detailed analysis over on Substack including links to all the supporting studies and trials. A link to my Substack is on the screen and a link to the articles in the video description.

[00:04:05]Another way we can get some insight into the impact of the drug is looking at reports from those who participated in the trials. During some of the trials, including an ongoing openlabeled safety trial, participants knew if they were getting the real drug or the placebo, and some of them reported their experiences in the various online forums. Again, the results seem to be mixed with some people reporting improvements, but a majority suggesting they saw no change. Bear in mind though, this is a very, very, very small sample.

[00:04:40]If you want to see the actual anecdotal reports, then head over to my Substack article. Given that the drug should have a powerful antioxidant effect, you might have expected the results to be more significant than they were. But bodies rarely behave quite the way we expect them to. And many airs is a complicated beast.

[00:05:01]It could well be that oxidative stress is part of our issue, but there are obviously other things going on. In addition, it increasingly seems that many may well not be one disease, but a collection of subtypes. And it could be that SPI 105 will end up being very helpful for one or two of these subtypes, but not all of them. Something that future drug trials might need to focus on. So to wrap up, it looks like SPI 105, although not a miracle treatment for many years, may well help some people to some degree with the awful hearing loss and tinitus that we suffer from. Based on the fact that there are no other drugs available that target hearing loss, the FDA has awarded both fasttrack and breakthrough therapy status to SPI 105 and the hope is that it may get approval before the end of 2027.

[00:06:01]I'll be keeping a very close eye on it and of course I'll let you know. So like and subscribe. Not only will you get any updates about this and future Many Air topics, it helps the algorithm know that the information is useful to other sufferers. If you'd like to see me do a deeper dive on YouTube into the trial data, let me know in the comments below.

[00:06:24]Otherwise, if you want to dig deeper into SPI 105 and other many topics, head over to Substack where you could also choose to donate to support my work if you want to. Season.