Update on AM-101 (aka Keyzilen)

AM-111 also failed in phase 3.

That's 2 drugs from this biotech company that has failed now.

The only other drug in development is one used for vertigo a type of betahistine.

The share price of this company has dropped massively - it could of quite easily went the other way though if the AM-101 and AM-111 were successful.

Also, it will be interesting to know if they plan to continue with the mysterious AM-102 - an updated formula of AM-101 being investigated for tinnitus.

Otonomy are also developing a drug similar to AM-101 - again - it would be interesting to know what they will do now.

 

Looks like the company is down 93% this morning on the latest results from the AM-101 study.

I remember reading about AM-101 10 years ago, back in 2008. In 2010 I even emailed Auris, seeing if there was any possibility they'd bring studies to Maryland. Their CEO, Thomas Meyer, actually emailed me back. I was really impressed with them.

It's definitely sad things didn't work out. I had previously bought some stock back when it was $5 a share, partly misguided by me wanting the company to succeed rather than knowing much about the success rate of biomedical companies. I sold at $2. I know better now, most of these companies will probably fail, though I'm grateful that there are so many working towards a cure, rather than the way it was in 2008, when it seemed like there was almost no hope.

 

I also came across Auris Medical in 2008, remembered when it was $5 a share and I was wanting to buy some myself, however I held back until and thankfully never bought. It's a penny stock now, so disappointed for them. I even heard Thomas the CEO bought stock himself... ohhhh shit balls.

 

Well color me surprised. Lol.

This company has been a huge dissapointment twice, yet people are going to keep supporting it I'm sure. There's no point in staying on a sinking ship.

 

Stock price was $0.25 yesterday and $1.50 today, huge increase?

 

A company restructuring took place this week which included 10 old shares for one new one – likely done with the sole purpose of increasing the share price 10-fold (in order to climb above the price of one-dollar per share i.e. above "penny-stock territory" which is required in order to not become delisted on the NASDAQ stock exchange).

The actual share price of EARS has actually fallen since the news broke, yesterday...

 

No reverse split (10 to 1) inflated the value, and it has already dropped substantially from that value.

 

Well, the news yesterday certainly was not quite what I had hoped for (or expected). And I can only assume the same holds true for Mr. Meyer – who at the KOL call last week – used a phrase along the lines "two shots at goal" (when referring to the Hochberg statistical test that would allow for confirmatory testing in both the overall study population and the subpopulation concerning otitis media). Put another way: it did not seem like he already knew what was about to transpire yesterday when the business update from last week was held. And extending the trial back in late 2016 with an additional 120 participants (costing a couple of million dollars) would never have been done if there was not a belief that the drug has potential. In my opinion, at least...

It would have been wonderful to see the first drug for tinnitus (even if only for acute-stage tinnitus) make it to the market. As late as yesterday, did Mr. Weber (at an Otonomy event) confirm that hidden hearing loss is on the rise (affecting the younger generation – i.e. those who still have many years ahead of them). With AM-101 having now been derailed twice in phase-III studies, it seems unlikely the tinnitus community will have any treatment for quite some years to come (e.g. the timeline for OTO-313 and OTO-413 are such that we will probably not hear any evidence of efficacy before some two years from now – and that's just considering the early-stage trials for both; much more work would then come after that...). So... this is probably the time when those reading this should be looking for a comfortable seat to sit for the next 5-7 years...

 

Just to add to what other commenters have posted, I was using Google Finance for my numbers (just google "$ears" and you'll see the stock chart). However, they seem to have adjusted the percentage they're displaying - it now says -37%, so the -93% number was probably a glitch on their part.

 

Didn't work. 0.5 mg/kg. She suggested upping the dose next time. I don't know if I bother...

 

Ketamine is not specifically known to reduce tinnitus through IV-infusion. Lidocaine is, however. And that is actually an important axiom in the study of tinnitus pharmacology – because it allows us to know that tinnitus can be modulated. We don't know why it works, but that doesn't matter: the important point is that tinnitus can be affected pharmacologically. "Only" downside to Lidocaine is that the long-term side-effects are unacceptable. Lidocaine is neurotoxic and one of the side-effects is actually tinnitus!

 

Thank you for your response attheedgeofscience. I notice you are very thorough and I'm happy that you contribute to this forum. If there is no chance ketamine can help I will have to decide if I want to cancel the next infusion.

 

Feelsbadman, but thank you for at least being realistic/honest and not pretending everything is fine.

 

So you don´t think Frequency is worth a mention in this context?

 

Frequency is definitely worth a mention. I think they’re the best bet right now for tinnitus and hearing loss treatment. The approach they’ve adopted is what convinces me. It’s simple compared to other methods and that’s a great thing. The more complicated it is, the greater chance of failure. If Frequency fails, you can bet there won’t be anything else on the horizon for many years.

 

Frequency's aim is to cure/treat hearing loss, If it also treats tinnitus that would be a bonus, but don't hang too much hope as it is first and foremost for hearing loss.

There is not much to go on that frequency approach of regeneration will do much, or anything, for tinnitus! Not being negative - but the truth is NOBODY YET KNOWS and with the associated link between the brain and tinnitus, for me, I would not consider it highly likely.

 

I think ATEOS only mentioned medications in the pipeline that are soley targeted for T. Frequency isn't for T. However, he did forget to mention Susan Shore's signal timing stuff. Albeit it's a device based therapy, not a medication.

 

I think the solution will be related to treatment of hearing loss. Many have claimed that hearing aids or even cochlear implants have reduced their tinnitus to some degree. The same should apply here. Exposure to sounds eliminates mine and ear plugs or silence makes it louder. Of course this solution doesn’t cover the whole spectrum. Those with TMJ or other mechanical issues will not be spared but they have other avenues to explore unlike us. This will probably be our only option.

 

Frequency's hearing loss goal should (hopefully) treat the tinnitus for those suffering with hearing loss. This would be a massive win for the "ear world" and lead to future investment and research.

We just need one company to make a break through in hearing loss treatment to start a flurry of activity and future investment which would ultimately benefit us all.

Now time for the rant:

What really makes my blood boil is seeing how much our Government (Australia) wastes on social welfare to the "unemployed", the majority of which don't even look for work, yet are more than capable. It's forecasted the cost to look after the unemployed in Australia will be $12 Billion next year, the remaining $180 billion is for those who genuinely need it...veterans, aged care, disabled and that is not enough.

On top of that, we waste even more money sending Government diplomats overseas to bail out criminals in foreign countries, criminals such as pedophiles & drug dealers....the scum of the earth.

5% - 10% of that $12 billion invested into something like hearing loss would be amazing, not guaranteed to find a cure, but a worthy investment that could also assist those who are mentally struggling with hearing loss and tinnitus.

Even for the current hearing devices available (hearing aids and cochlear implants), very minimal government support in Australia, really sad when you think about it.

Sorry for the rant, but there is just so much wasted tax payers money that could be genuinely helping all of us, which I am sure is the same in the US, UK and all other countries around the world.

 

Thomas Meyer founded Auris in 2003 and was the company's sole shareholder until the end of 2007 where they listed OTC. Before 2014 as an OTC issue, before the Nasdaq offering of 2014, I posted that I had T on their finance Yahoo board. I was ripped apart by some. They laughed that I had T and I'm sure that you @patorjk understand why. I posted on hundreds of stock boards back then and viewed thousands on occasion and only twice did I see a CEO post. Thomas Meyer posted to me when I was in distress with caring concern. I will never ever forgot that.

@patorjk Your heart is in the right place. Welcome to the board.

Thomas Meyer and newer managers meant well. It's hard in this space for companies to raise cash, as a few have gone public. Bashers from finance message boards and shorts that go hand in hand will slow down money manager investing. That did happen when the share price was higher. There are some large public companies researching drug compounds for tinnitus as that can be seen by reviewing their research expenses and other items.

 

Well ladies and gentleman...
AMother-101 bites the dust:

http://hearinghealthmatters.org/hea...al-disappointing-tinnitus-drug-trial-results/

Stay calm, be patient and walk away.

 

I like how apparently this was a big surprise. I wasn't even aware there was another AM trial coming up, because I wasn't paying attention because I knew it would just fail as usual.

AM failing again isn't some sort of big defeat like we're treating it right now. That's like rooting for the sun to stay in the sky and getting mad when it sets. It always does that, no need to expect it not to.

 

There is supposed to be a Q&A with Otonomy from Tinnitus Talk, perhaps this could be talked about with them and their plans for OTO-311 as it supposedly works on the same principle (NMDA receptors etc).

 

When people have hearing loss and tinnitus from otosclerosis (fused ear bones) or ear wax buildup, tinnitus often goes away when the cause of the hearing loss is cured. I read somewhere that in roughly 50% of otoscleroris cases with tinnitus, curing the otosclerosis improved hearing and fixed the tinnitus. So it seems highly likely to me that a treatment for hearing loss would also treat tinnitus, at least in cases where the tinnitus is associated with hearing loss (which is most cases, I think).

Even in cases like mine; my T goes away for a while when I hear noises around my hearing loss frequency. I think I'm just not hearing those noises well enough naturally; if I was, the tinnitus would always be gone, the way it is now when I listen to specifically-designed masking sounds.

So, I've got high hopes for Frequency's approach, as well as CGF166.

 

You are correct in your statement, but the otosclerosis case is a different one. The genesis of T is different in the "pure otosclerosis" case (ie only conductive losses) vs sensorineural losses. There is a scientific explanation that describes the characteristics of cochlea fluids (perilymph, endolymph) due to bony growth at the stapes and the spurious noises that could be generated from that situation (I don't have the link handy, but it's an interesting read as it uses fluid mechanic laws to explain the phenomenon). Once the ossicular chain is "freed" this condition (via stapedotomy/stapedectomy) goes away, and so the sound that it was responsible for goes too. When it's a middle ear only condition, otosclerosis leaves hair cells intact, so a successful stapedotomy will bring back an almost perfect hearing.

With SNHL, hair cells and/or synapses are often damaged, and that creates a condition downstream from that for the genesis of T. Whether that condition reverses if the hair cells/synapses get repaired is the billion dollar question.

 

I don’t know if that has been posted, but anyway. https://www.biospace.com/article/auris-medical-fails-again-in-phase-iii-trial/?s=69

 

Hmmm... not sure I fully agree with this. The general consensus/assumption amongst the members of this community seems to be that, in the case of Auris Medical, it is the drug itself which is at fault. What if in fact it is the not the drug that is at fault, but the inability to demonstrate efficacy due to factors such as:

• Obtaining a standardized patient profile which specifically matches the etiology dimensions required
• Clinical trial design
• Placebo response
• Efficacy variables available for assessment (e.g. how to rate an improvement such as via MML and/or the TFI)

If the drug is at fault, then it's easy enough: wait for the next big thing to hit the news. But... if other factors are at play, then those "next big things" to come along may well be subject to the same problems as we have seen with AM-101. And history will repeat itself, in that case.

In addition, the consistent inability to bring a drug to market is not going to please investors. Simply put: why risk your investment when you can place your money earning the same ROI with a lower risk somewhere else? So, results such as those seen in the AM-101 trial or the QUIET-1 study could have wider implications.

And lastly, if Auris Medical would have had more success early on with AM-101 and AM-111, they could have become the experts in the field by cementing their market position against competitors. This could have led them to earn revenue needed for further research and eventually become the experts and develop additional therapies down-the-road. Now Auris Medical looks like a company struggling for survival and perhaps this may end up with the tinnitus community losing out on a lot of progress and collateral damage.

Something to think about, I think...

 

How is it possible that all those stupid products such as Tinnitus +, or Tinnitus Relief, that have no effect whatsoever, get on the market, and this Keyzilen thing that has a somewhat direct effect on tinnitus, can't at least get to the market so that the People can at least try it out??? This is all very suspicious to me... It seems like someone is trying to prevent this from being released just for the sake of these stupid and useless tinnitus tablets -.-' I am starting to get really really angry...

 

They are subject to different regulations (i.e. you can pick them up in a supermarket, not a pharmacy). Incidentally, a report by The Economist stated, that in the United States three billion dollars are spent annually on homeopathic medicine which has no proven effect what-so-ever (except if your name is @Michael Leigh). If people are going to throw money out their window (three billion of it, no less), then at least spend it on something that has value.

Kind of an eye-opener knowing how stingy the tinnitus sufferers themselves are in supporting their own cause: let's spend money on something totally useless, but tinnitus research, forget about it...

 

P.S. I should add that there is an additional pathway to market in the EU which includes a conditional approval (by the European Medicines Agency) where the medication is allowed to be sold while an ongoing trial takes place. This is what Auris Medical mentioned they might look into for AM-111.