Otonomy Starting Phase 1 Trial in 2015 for Tinnitus

They claim that their compound has 5x more affinity towards NMDA receptors. It's tempting to say that it will be more efficient because of this but more often than not this assumption is wrong.

 

I suppose it's not as simple as that. There are other aspects such as tolerability of a drug. Also it's not always the best solution that wins in the end. If you think of DVDs and Blu-Rays, the best technical solution didn't win and got to be the standard. They could come out on top in the end even if their drug is less effective on paper. Auric Medical also have time on their side as well because they will be able to launch their drug years ahead of Otonomy.

 

The good news for us is that when a drug is developed and proves efficacious, even in a specific cohort of patients, other pharma companies then try to 'better' that drug in order to grab the business. So they will look to improve efficacy and/or tolerability and/or a target a larger cohort of patients etc etc. So if this drug is targeting acute sufferers I would think they will then go on to focus on chronic sufferers, or another company will.
A drug that works for chronic sufferers will instantly recoup the money it's taken to research and develop it because of the numbers of patients involved - tens of millions. Most likely it would be a treatment patients would need to take long-term too so that's a win/win for the company that develops it.
Like most therapy areas, it just takes one company to develop a safe, efficacious drug for tinnitus then others will follow. Pharmaceuticals is a very competitive industry and particularly with a 'first in class' medication. It just takes that first drug to hit the market - here's hoping we get one soon !

 

In my opinion, revolutionary progress in the area will occur and we are not talking treating acute case but restoring the entire auditory system. The direction will change, the timetable these companies set is just to slow. Preventing further damage is something useful but it is not a cure. And, of course, this will not do any good to any of us here...
Lets hope these wanna-be therapies for only acute phases (like for the first 6 months) will become obsolete really soon.

 

I have read the papers about gacyclidine and the following things are known:

But the OTO-311 seems a bit flaky to me. Seems a bit too much of a sales company if you ask me, but okay if it works it works.

And the following is still unknown:

-Four out of 10 people have suppression due to gacyclidine. So 60% did not.
-Long term administration of the drug is needed. How long?
-Short and long term safety effects.

 

That is what the clinical trials are for.

And all pharmacuetical companies are 'sales companies'. The largest employee sector of most pharma companies is their sales force.

 

Yeah I know. But you might expect that there is more than 1 health supervisor in their board. Like you have 5 people doing sales and 1 medical dude. Why? Shouldn't that guy be reviewed?

And the clinical trials cannot see inside your brain, what the effects are over time.

 

No clinicals trials cannot see inside your brain but that has always been the case with any drug that affects the brain - anti psychotics, anti depressants, epilepsy drugs, even paracetomol. This is why new drugs are closely monitored for years in order to discover what the affects are over time.
And drugs that make it to market have gone through very robust, rigorous safety and tolerability trials to prove that they are safe and well tolerated before they get the authorisation to be marketed. If there is any doubt they do not get passed the regulatory authorities - this is the case no matter who is on the board of the pharma company.
And with any new drug that comes to market, it is ultimately the patients choice whether they take it or not.

 

Paracetamol is one typical drug that in recent studies has shown to be "nobody knows what it actually does". I have seen that from a Dutch University recently, they reviewed it on TV.
Anti depressants are under full hammer these days as people can turn into psycho's which is uncontrollable for any bystanders. The so called "very robust" trials are on a limited scale and almost none of them looks over a period of more than 5 years time. Because this research is super expensive, there is no such thing as an independent advisory board who reviews it. Look at the works of Peter C. Gotzsche, who is well known for it's criticism at big pharmaceutical companies.

As every story you have to see both sides. Yes there are drugs that help and cure people, but a part of the farmaceutical world is filled by corruption and paying of doctors to prescribe drugs. Some drugs are prescribed from a typical brand only the insurance company gets an incentive and so on. With this new drug we should be careful, it's not like it's candy.
Maybe the farmaceutical company has a motive we cannot be aware of. I'm not a conspiracy teller, I'm just reading on both sides of the book. Look it up for yourself.

 

Paracetamol is a drug that's been around for a long, long time and when it came out over 100 years ago our knowledge was a joke and the process of testing drugs wasn't as rigorous as it is today.

You are writing that "anti depressants are under full hammer these days". That's the proof of drug evaluation. A drug goes through rigorous testing for a number of years before it's approved and after it's release on the market it's monitored for decades to measure long term effects.

The alternative would of course be to demand long term testing BEFORE release. But then developing a drug wouldn't take 10 years or so but 3-4 times that time and the costs would be astronomical! If we did that we wouldn't cure anything and no one would be interested in developing drugs. We would still have children dying from polio, pneumonia and other infectious diseases. And for us with tinnitus!? Well, we'd be happy if we had a cure by the year 2900, if ever!

 

The study you are referring to is the Wenzel study. It was a study put in place for compassionate help to a limited number of patients (10 or so). The patients were (probably) not chosen for their patient profile (from a tinnitus perspective), but, instead due to their suffering (all were deaf, unilaterally). The fact that they were deaf meant there was no risk from the intervention which required direct access to the round window membrane (i.e. should the inner ear perilympathic liquid spill out, they would have nothing to lose as they were deaf already). So in a sense, the patient profile was: mitigation of risk first, tinnitus profile ideology second.

However, by being unilaterally deaf already well before the intervention, probably most/all patients were chronic sufferers. High doses of Gacyclidine were given under ideal conditions (as the physicians had direct access to the inner ear). As the study was done on a compassionate basis, it probably did not set out to prove anything: it was just that - a study - capturing what did (or did not) happen to the 10 patients.

From a researcher I correspond with frequently:

I have no specific knowledge of OTO-311 (other than that which I have posted within this thread), but I suspect that OTO-311 will not deliver the same amount of Gacyclidine to the inner ear that the Wenzel study did. But then again, the patient profile means everything (i.e. acute vs. chronic patients; see quote above). Of course, OTO-311 may deliver Gacylidine to the inner ear over a longer period of time (as opposed to a short high dosage intervention). Certainly, OTO-311 and the inner ear compounds of Otonomy are "patient friendly" requiring just one puncture to the tympanic membrane.

Anyway, we can speculate all day long. In the end, only results matter, and that is exactly what a clinical trial sets out to do.

attheedgeofscience
24/JAN/2016

 

@attheedgeofscience

With regards to the acute phase vs chronic that's what I keep hearing, and it makes sense. But how long does the "acute" phase actually last? I have heard everything from months to the cascade of neurological changes happening almost immediately. And how does one differentiate the two if it's a variable amount of time?

 

No one can reliably answer that question. It is unknown whether or not you can stop the exitotoxic cascade that happens in the inner ear once it is set in motion. Once you have nerve inflammation going on you only have a couple of days at best to stop the damage from spreading. It's best to act early. My guess is that 3 months is already too late for maximal benefits.

 

I emailed Otonomy asking for where will they do the Phase II trials. They dont know xD

 

That's not surprising given that the Phase I trial isn't over.

Speaking of the Phase I trial, is there information about it any place? I couldn't find it on clinicaltrials.gov, and there's no mention of it on Otonomy's clinical trials page: http://www.otonomy.com/pipeline/clinical-trials/

 

No info I guess

 

A phase 11 trial will only commence if the results from the phase 1 trial are positive. I think the phase 1 trial has only just started so it will be a little while yet before we know the results and when/if and where a phase 11 will begin.

 

Hey! What is up lately with this OTO 311 thing? I'm really looking for it because I got acute T yet.

 

You should also look into AM-101. I think they are still recruiting participants.

 

AM-101 are still recruiting.

 

I believe today is the last day for AM-101 recruitment in the US, at least at some of the recruitment centers.
https://www.reddit.com/r/tinnitus/comments/4a6y3n/attn_am101_tinnitus_trial_is_closing_enrollment/

 

Thank you for the information. I hope there will be some good news for us.

 

Btw, for those with Meniere's: The European part of the OTO-104 Phase III trial just started.
http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-newsArticle_Print&ID=2150394

 

Phase III sounds promising?!

 

I don't believe that OTO-104 is going to be very relevant for people with t.
It's just dexamethasone injections to the ear (intratympanic).
I believe lots of members in this forum have gotten them with little success.
However, it might be beneficial for people with Meniere's. Researchers are saying that Meniere's might be linked to autoimmune problems and corticosteroids (like dexamethasone) are the only current treatment for such issues.

 

I do not find anything on the website "tinnitus talk".
I think it involved Charles Liberman, one of the greatest researchers in the world about tinnitus.
http://www.otonomy.com/pipeline/oto-311/

 

is it also for chronic T?

 

All what we know right now is that oto311 is 5 times more portent than Am 101

 

Really? Interesting. I report this news to my group (i am the admin of official italian tinnitus group on Fb).
Do you know if the great Charles Liberman is involved in this research?

 

Bump this thread for no news from my side.

Anything you guys know? When they will give more details? I do not want to rise my hopes for anthing is not known if it is for acute or chronic.