Otonomy OTO-313 — Treatment of Tinnitus

https://www.google.com/amp/s/www.evaluate.com/node/12915/amp

This is pretty depressing reading

 

I see nothing, can you summarize. Says the article isn't available.

 

short summary:
All the "wonderpills" of auris medical have failed or have a very high possibility to fail....

 

I missed something, is that already posted?

https://clinicaltrials.gov/ct2/show/NCT03918109

Are there some fellows here who have been enrolled?

EDIT: it seems that this clinical trial is open for acute tinnitus but also for chronic tinnitus.

EDIT2: as @FGG reported, enrollment is completed
https://www.tinnitustalk.com/threads/otonomy-q1-2019-financial-results-business-update.34788/

 

An update on those in the CA area, Otonomy is now recruiting in Los Angeles and San Diego for their phase 1/2 trial of OTO-313 for the treatment of tinnitus.

United States, California

House Clinic Recruiting
Los Angeles, California, United States, 90057
Contact: Shanel Hill shill@hei.org

California Head & Neck Specialists Recruiting
San Diego, California, United States, 92121
Contact: Tricia Doughty 858-909-0770 tricia.doughty@calhns.com

I myself am thinking of giving this a shot.

 

I think it’s only for acute cases, not chronic. Maybe you are within the timeframe? I called Silverstein and they said I had tinnitus too long to be in trial.

 

Wow in LA too!? I might give it a shot as well since LA is about an hour drive from where i live.

 

Aww shucks, I'm sorry to hear that. I really feel like this acute and chronic stuff makes not much sense. If the mechanisms are the same, it shouldn't make much of a difference.

I think I might, I've only had this for 6 months. They actually already got back to my email inquiry... I'll be having a chat with them pretty soon.

Hahaha good gif.

Where do you live? I'm about 20 minutes from downtown without any traffic. An hour away too if there is traffic.

 

Surely you know of the theory where longer term tinnitus gets stuck in the brain and becomes a brain problem instead of an inner ear problem. In chronic cases you need a pill from Dr. Tzounopoulos or such.

 

I think it's a brain problem to begin with. Sure it starts with an ear problem, but pretty much as soon as you hear the ringing you best believe that's the brain making the sound.

Dr. Shore's research says the root cause of tinnitus is hyperactivity in the dorsal cochlear nucleus, part of the brainstem. It could be that it thinks it's fixing or compensating for something wrong with the ears. The way this drug works is that it's a blocking a neurotransmitter that pretty much is telling the brain, well, there is something wrong with the ears. My hopes here are that if the brain no longer is recieving the signal that something is wrong, the hyperactivity will stop.

 

Is Silverstein in on the trial?

 

Please stop repeating this nonsense. I'm begging you.

 

This has not been proven.

 

Yeah they are listed. The contact person called me back. Judging by their stock price it probably doesn’t work. Worth a try for those eligible though. Only half a chance of getting the real thing I suppose.

 

Stock price is not at all a way to judge if a drug works. Small cap biotechs are famously easy to manipulate for large capital firms.

Price also depends on the greater market, the biotech sector in general and sometimes if it's just "too slow" and people found a quicker avenue for their money so got out. The bulk of funds for any given stock are for huge players anyway, a great number of these are just algorithm trading with each other (computers trading with computers).

Plenty of stocks had bottomed out, only to have approval later.

The drug may or may not work but stock price during trials isn't a very good indicator of that.

 

You know a lot more than me about evaluating stocks, that's for sure. I just know OTIC's formulation was similar to EAR's, only more potent. A stock selling off from about $20 to $2 can't be a good sign regarding investor's confidence. And it's remained low for a long time with very little volatility.

Of course I hope OTO-313 works for tinnitus.

 

The sell off was for their Meniere's drug (sustained release intratympanic steroid) not meeting clinical endpoints. However, I believe it was later shown that the drug worked really well in earlier phases and doctors were telling people this to recruit them and inadvertently making the placebo more effective for vertigo in the process. They have restarted a phase 3 with new FDA guidance after this if I understand correctly.

Either way, sell off had nothing to do with OTO-313 or OTO-413.

 

I guess I'm not eligible? :/

I've had it for a year and a half.

 

Damn.. I seriously think they take that so seriously for no reason, @JohnAdams all research, pretty much from every direction, is pointing at the brain making the sound. Yes it's in response to damage in the ear, but it's not the ear making the noise, it's the brain.

 

I don't believe it. I'm sure they can see the brain lighting up in the auditory cortex, but that just means it's getting a signal, I think. I surely don't know for a fact, but it's my absolute opinion.

 

Isn't the current hypothesis that the brain creates a sound in response to missing input? Perhaps it's both?

You restore hearing though, the noise should stop.

 

How are they to know if you say it's only been a few months?

 

Lie.

 

It seems they just have to take your word for it.

 

I think if you restore hearing or if you get the nerve excitation to stop, it can stop.

I do think there is a component of it that is in the brain (i.e. from what I understand, people who have had their entire cochleas removed can still have tinnitus) BUT restoring normal signal should stop the "phantom" sounds since they are compensatory. I highly doubt it's just "stuck" there since the brain is so plastic anyway.

 

Piggybacking on FGG's comment, I work with a guy whose hobby has been stocks for many years and he's had some success. His advice to me is "you always wait until just before they release the Phase 3 trial data to buy." The idea being that if Phase 3 proves the product will work, people will start buying the stock like crazy. But you don't want to buy when they are phase 1/2 because "your money just stagnates."

It seems that companies who are publicly traded don't get rewarded with money until after they've proven their product will work, which on the one hand makes sense and is good incentive to come out with a good product. On the other hand, it could (and this is just me speculating) take longer to complete their work because funding isn't as generous earlier on.

Concerning the fact that they are limiting their early Phase trial participants to acute sufferers, I kinda feel like that's a move to have really good numbers up front, since tinnitus can diminish on it's own in the first few months. So you maybe have some people actually improve because of their drug but others maybe get better regardless. Their 2017 reports on their Otividex product were not promising and they had to go back and rework it. This trial could have some built in damage control so they don't lose more investor faith. Not saying it won't work or they are dishonest. Just a theory.

 

Neuroscience has come a long way, we used to think the brain never spawned new neurons after birth, today, that's entirely flipped on its head on a 180 spin. The brain is extremely plastic, mindfulness meditation has been proven to enlarge the hippocampus and frontal cortex, and shrink the amygdala.

We know today that the adult brain does in fact constantly generate new neurons, BDNF and NGF are the main driving molecules for this mechanism.

What Dr. Susan Shore/Minnesota/Neuromod are doing is 100% scientifically accurate, because we know we can alter the shape of the brain with training.

 

Used to be a hobby of mine, too, when i still had a career and money to risk.

I mostly agree with your friend, but it really depends on the drug and potential market (and the share price if it's a bargain). You could have easily doubled your money on Durect recently, for instance, before and after phase 2a for their NASH drug, but I think it helped a lot that it was undervalued and you could have bought in under $1. There is definitely a buy and hold long term crowd +/-that use their shares in hand to write options or even just hold for at least a year to get less capital gains tax. Or... if you were like me the complete "win or lose big" binary aspect made me nervous enough to have sold off at least some before FDA approval hearings.

Re: Otonomy. Man, that would be shady to select a drug/trial on acute sufferers to pad their results. I really don't think so. It would seem to be even harder to prove effectiveness over placebo in that case I would think. One of the founders has Meniere's, so that also gives them more credibility for scruples imo.

 

Don't you think if we regenerate the hearing, it's going to be 50/50 on tinnitus? In the sense that when someone uses hearing aids, sometimes it makes the tinnitus disappear, reduces it, or does nothing at all.

Don't you think that on hearing regeneration it will be a bit the same type of lottery?

 

Hearing Aids,in my opinion,help mask the T and those who don't get relief,more then likely have hearing loss at the higher frequency.Restoring Hearing,again in my humble opinion,will fix T.That is of course if you T is related to hearing loss.I believe that the brain will make the proper adjustment upon hearing restoration,although it may take a few months.This is all speculation of course, since we haven't regenerated Hearing(Audion/Freq probably have),but we will hopefully have the answer's to all these question's soon.