Hough Ear Institute's Hair Cell Regeneration Project

[mrbrightside614]

Frequency recently tweeted an article suggesting that, most of the time, clinical stage biotechs do not have any difficulty getting the funding they need and that the NIH should fund more general "basic science" instead because these are the blueprints research needs to build on before the future profit becomes obvious. It was an interesting take.

If the ATA actually does fund seed grants, that might be a net good to have seed money lauching research at the very early stages, too

It is super frustrating that Hough has to raise funds for their pill but because they are a non-profit, but they might be the exception and not the norm. They might not have the same kind of relationship with biotech investment funds, etc.

All you would need is one wealthy donor with tinnitus to fund the half a million, though, perhaps something like the Gates Foundation or an individual philanthropist who has tinnitus who isn't aware of this drug might help. I wonder if a musicians' organization even would be interested in knowing about the pill.

I so totally agree with you on organizational transparency, though.

I'd just like to see one compelling study that declared funding through the ATA so that a "track record with success" could be substantiated for a condition that has not been cured and consistently displays various mechanisms by which it may act that have not been appropriately followed up on.

Example: Intratympanic Dexamethasone in the Treatment of Acute SSNHL and tinnitus.

-Hold a conference for PCP's and GP's to raise awareness about referring patients with these complaints to trial centers and stress the need for immediacy (<1 month since onset)

-Conduct extended pure-tone audiometry and speech-in-noise tests at baseline

-Record time of patient registration relative to onset

-Deliver the drug on whatever dosing schedule appears most prudent

-Have patient follow-up testing at 1-month, 3-months, 6-months and 12-months post-administration

The fact that there is very little useful scholarly data for the only available preventive intervention for chronic tinnitus is unacceptable. This would be my first move as ATA president. Then you can start looking into comparison vs. placebo (or just cross-examine no-treatment tinnitus progression research), comparison vs. oral prednisone/adjunct therapy, neural imaging, lidocaine MOA's, sleep architecture & effect of REM, etc.

If we had appropriate distribution of grants, companies like Otonomy might not have to waste their time messing with gacyclidine and ChrisBoyMonkey would be better off. I'm not saying OTO-313 will flop, or that dexamethsone treatment is tried-and-true, but that's why you FUND the hell out of it for appropriate scientific understanding. It's cheap as hell, and it makes no sense as to why it's not the first thing on PCP's and ENT's lips when a patient presents with SSNHL.

 

[mrbrightside614]

That's a bit of a reach. Yes, a common correlation of tinnitus sufferers is hearing loss. But that's not the rule. Stress, TMJ and ototoxicity are causes as well. Not to mention you can have hearing loss and no tinnitus. Therefore nothing is mutually exclusive.

"Treating hearing loss in the current available ranges has historically rendered consistent results". Currently available meaning hearing aids and results meaning it doesn't work? What are you getting your info from?

Several members of this board in addition to the patients of Dr. Kopke respond well when tinnitus tones are in the ranges hearing aids address. The figures Kopke produced/estimated are in this thread, probably only a page or 2 back.

 

[FGG]

I'd just like to see one compelling study that declared funding through the ATA so that a "track record with success" could be substantiated for a condition that has not been cured and consistently displays various mechanisms by which it may act that have not been appropriately followed up on.

Example: Intratympanic Dexamethasone in the Treatment of Acute SSNHL and tinnitus.

-Hold a conference for PCP's and GP's to raise awareness about referring patients with these complaints to trial centers and stress the need for immediacy (<1 month since onset)

-Conduct extended pure-tone audiometry and speech-in-noise tests at baseline

-Record time of patient registration relative to onset

-Deliver the drug on whatever dosing schedule appears most prudent

-Have patient follow-up testing at 1-month, 3-months, 6-months and 12-months post-administration

The fact that there is very little useful scholarly data for the only available preventive intervention for chronic tinnitus is unacceptable. This would be my first move as ATA president. Then you can start looking into comparison vs. placebo (or just cross-examine no-treatment tinnitus progression research), comparison vs. oral prednisone/adjunct therapy, neural imaging, lidocaine MOA's, sleep architecture & effect of REM, etc.

If we had appropriate distribution of grants, companies like Otonomy might not have to waste their time messing with gacyclidine and ChrisBoyMonkey would be better off. I'm not saying OTO-313 will flop, or that dexamethsone treatment is tried-and-true, but that's why you FUND the hell out of it for appropriate scientific understanding. It's cheap as hell, and it makes no sense as to why it's not the first thing on PCP's and ENT's lips when a patient presents with SSNHL.

Oh if that's what the ATA does with funding, that's pretty useless. At least groups like the Hearing Health Foundation fund valuable new research. So is the ATA the Susan Komen of tinnitus?

I would argue that the problems with OTO-313 have nothing at all to do with funding, though. My guess is they don't yet know what subtypes and what time frames the drug will help. Maybe basic science around subtyping would have helped with that which was kind of the point of the link Frequency posted. Otonomy had enough money to spend on pre-clinical work and IND enabling studies. They also had results of AM-101, so I am really not thinking funding was the problem in that case.

 

[mrbrightside614]

Oh if that's what the ATA does with funding, that's pretty useless. At least groups like the Hearing Health Foundation fund valuable new research. So is the ATA the Susan Komen of tinnitus?

I would argue that the problems with OTO-313 have nothing at all to do with funding, though. My guess is they don't yet know what subtypes and what time frames the drug will help. Maybe basic science around subtyping would have helped with that which was kind of the point of the link Frequency posted. Otonomy had enough money to spend on pre-clinical work and IND enabling studies. They also had results of AM-101, so I am really not thinking funding was the problem in that case.

That is the exact analogy that comes into my head when comparing them to a known quantity. Susan G. Komen may be a private non-profit and not centrally funded though, I'm not sure.

This is why people hate bureaucracy—it's bloated and operates behind smoke and mirrors when they should be BY the people FOR the people, since our taxes pay for their existence.

I was just demonstrating HOW EASY it would be when you have a name-brand organization that holds an annual conference with presumably high participation of practitioners. It would be incredibly easy to disseminate information about trials and compliance would be high because people obviously want to take whatever they can, as soon as they can to silence the banshee that's developed in their ears. I have never seen a study I've liked declare funding by the ATA, and you have to declare it if it was through grant funding.

 

[ajc]

I have never seen a study I've liked declare funding by the ATA, and you have to declare it if it was through grant funding.

https://www.ata.org/news/news/pitt-researchers-awarded-2-million-grant-develop-drug-tinnitus

Thanos Tzounopoulos got seed funding from ATA.

 

[mrbrightside614]

https://www.ata.org/news/news/pitt-researchers-awarded-2-million-grant-develop-drug-tinnitus

Thanos Tzounopoulos got seed funding from ATA.

He gave them a shoutout for his first grant. It wasn't the $2m grant, that was supplied by the DoD. I'm sure the first grant was for far less (speculation), and would like to mention that $2 million really isn't all that much money. It certainly won't bring a drug through trials, as we've seen here.

 

[lymebite]

$2 million really isn't all that much money

Everyone should keep in mind that the ATA is a relatively small organization that struggles to raise money. In the most recent year they have provided financial results (their fiscal year ending June 30, 2017), they raised a grand total of $827,727.

Of this amount raised, only $130,258 went to grants. Better than nothing I suppose, but a drop in the bucket. $2 million is not much, and $130,258 is a whole lot less.

The full tax return with this information and more is available on the ATA website.

Link to all ATA financial reports:

https://www.ata.org/about-us/annual-reports

Direct link to the most recent tax return for their fiscal year ending June 30, 2017:

https://www.ata.org/sites/default/files/ATA 2016 990.pdf

 

[mrbrightside614]

http://otologicpharma.com/wp-conten..._Effects_of_Delayed_and_Extended_FRR_2011.pdf

Fascinating article examining ANOTHER nitrone compound's (4-OHPBN, not NHPN-1010) effects on acoustic trauma in adjunct therapy (antioxidants NAC + ALCAR).

Another interesting passage about distribution of damage relative to the apex: "Large losses (about 70%) induced by noise were observed at 55–90% distance from the apex, indicating high frequency regions (2–10 kHz). The functional and morphological con- sequences of noise trauma were significantly attenu- ated by a combination of 4-OHPBN plus NAC plus ALCAR."

 

[FGG]

http://otologicpharma.com/wp-conten..._Effects_of_Delayed_and_Extended_FRR_2011.pdf

Fascinating article examining ANOTHER nitrone compound's (4-OHPBN, not NHPN-1010) effects on acoustic trauma in adjunct therapy (antioxidants NAC + ALCAR).

Another interesting passage about distribution of damage relative to the apex: "Large losses (about 70%) induced by noise were observed at 55–90% distance from the apex, indicating high frequency regions (2–10 kHz). The functional and morphological con- sequences of noise trauma were significantly attenu- ated by a combination of 4-OHPBN plus NAC plus ALCAR."

Dr. Kopke (from Hough) is an author on that paper, too.

 

[mrbrightside614]

Dr. Kopke (from Hough) is an author on that paper, too.

Nice catch! He produces absolutely fascinating research. I cannot express enough how thankful I am for people like @Justin De Moss and Dr. Kopke. True innovators and problem-solvers with altruistic motivation. We need more of them in this cold, Luddite-run world.

I think it's interesting they threw ALCAR into the mix considering my prior speculation regarding its potential utility in the hearing regeneration space. I still wouldn't want to rock the boat and dose it concurrently with NHPN-1010 when that fateful day comes, though.

 

[AVIYT]

Everyone should keep in mind that the ATA is a relatively small organization that struggles to raise money. In the most recent year they have provided financial results (their fiscal year ending June 30, 2017), they raised a grand total of $827,727.

Of this amount raised, only $130,258 went to grants. Better than nothing I suppose, but a drop in the bucket. $2 million is not much, and $130,258 is a whole lot less.

The full tax return with this information and more is available on the ATA website.

Link to all ATA financial reports:

https://www.ata.org/about-us/annual-reports

Direct link to the most recent tax return for their fiscal year ending June 30, 2017:

https://www.ata.org/sites/default/files/ATA 2016 990.pdf

Every bit helps, although more would be better. In comparison, the BTA is now giving out a grant worth up to £125,000 (= around $161,600 currently).

 

[KyleM]

@Justin De Moss I'll take one magic pill please sir. To go.

I look forward to hopefully seeing more and more news from this topic.

 

[annV]

 

[thinlay]

Hello, ultimately this drug is not for chronic tinnitus?

 

[Mentos]

Hello, ultimately this drug is not for chronic tinnitus?

I don't believe it was said it's not for chronic tinnitus.

 

[Jack V]

He estimates its availability around 2025.

Chop chop.

Get it out there faster.

 

[Jack V]

Hello, ultimately this drug is not for chronic tinnitus?

In the video he says it's primarily designed for the immediate aftermath of noise trauma, but might also be useful for restoration down the road to some extent. So... possibly?

 

[mrbrightside614]

Lol is this an ironic username this was posted from? No way Jastreboff wants to draw attention towards ANY curative research.

 

[FGG]

Lol is this an ironic username this was posted from? No way Jastreboff wants to draw attention towards ANY curative research.

If you follow the link: "Pawel Jastreboff" joined 10 hours ago.

::slow clap:: excellent trolling dude/dudette if you are reading this.

 

[mrbrightside614]

If you follow the link: "Pawel Jastreboff" joined 10 hours ago.

::slow clap:: excellent trolling dude/dudette if you are reading this.

By my estimation there's like a 75% chance it's @Contrast.

 

[Joly]

Excuse me, I don't speak English very well, I'm French. So isn't the Hough pill just for acute tinnitus?

I contacted them to find out where they will be doing their clinical trials and whether there will be any in the EU.

Have you got any news ? If yes, do you know if they will have clinical trials in the EU?

 

[FGG]

Excuse me, I don't speak English very well, I'm French. So isn't the Hough pill just for acute tinnitus?

I contacted them to find out where they will be doing their clinical trials and whether there will be any in the EU.

Have you got any news ? If yes, do you know if they will have clinical trials in the EU?

Their upcoming trial will not be for tinnitus. It appears you have to be receiving a cochlear implant to be eligible for the trial, so you might not be eligible regardless of location if you do not have that kind of hearing loss.

Hough are hoping that, once the pill is on the market for use in the cochlear implant population, it can be used "off label" (this is a term for US drugs used for a reason it was not in clinical trials for) for tinnitus. It has not been tested for chronic tinnitus but they believe it will work for acute is chronic. They are trying to raise money for a "proof of concept study" for chronic tinnitus but i believe this will be on rodents (correct me if I have anything wrong, please @Justin De Moss).

 

[Mentos]

Excuse me, I don't speak English very well, I'm French. So isn't the Hough pill just for acute tinnitus?

I contacted them to find out where they will be doing their clinical trials and whether there will be any in the EU.

Have you got any news ? If yes, do you know if they will have clinical trials in the EU?

I asked Hough about clinical trials in Europe and the answer was negative. They will only test it in USA.

 

[rsmcfar]

A news article that came across my feed posted without comment.

https://kfor.com/news/local/researchers-in-oklahoma-city-developing-hearing-restoration-pill/

 

[MRItechssuck]

A news article that came across my feed posted without comment.

https://kfor.com/news/local/researchers-in-oklahoma-city-developing-hearing-restoration-pill/

The newscast begins by saying, "what Oklahoma doctors have been testing for years, we just never really heard of it."

Isn't that the truth! Thankfully some free advertising on television, maybe this will help with funding.

 

[Piney]

These timeframes are ridiculous.

It has been 6 years since phase 1 and when is the phase 2 going to begin?

I'm a cochlear candidate, well let's go already and let's see if it works.

6 years between trials would take a total of, what, 24 years? If I was a drug addict I could go to a rough part of town and get homemade Meth made by the local pharmacist, but I can't pay anybody for a possible hearing drug.

I don't want to hear any excuse for it, it's a broken system, the demand for the drug and profits are clear as day.

I may go to Oblato's front door and ask them what's going on. I have other trials I can be in.

Patients or those who are willing to succumb to trials' demands of poking, prodding, and drugs need to know these timelines to make decisions.

 

[Tweedleman]

These timeframes are ridiculous.

It has been 6 years since phase 1 and when is the phase 2 going to begin?

I'm a cochlear candidate, well let's go already and let's see if it works.

6 years between trials would take a total of, what, 24 years? If I was a drug addict I could go to a rough part of town and get homemade Meth made by the local pharmacist, but I can't pay anybody for a possible hearing drug.

I don't want to hear any excuse for it, it's a broken system, the demand for the drug and profits are clear as day.

I may go to Oblato's front door and ask them what's going on. I have other trials I can be in.

Patients or those who are willing to succumb to trials' demands of poking, prodding, and drugs need to know these timelines to make decisions.

I wholeheartedly agree with you, the timelines are absolutely maddening. At the rate they're going someone will invent a time machine before we get these treatments.

 

[Orions Pain]

Facial pain radiating from the ear is a standard hyperacusis symptom. The hyperactivity of the middle ear muscles (the clicking and popping and fullness TTTS type stuff) aggravates the nerves that signal these muscles.

Read more here if you'd like: https://hyperacusisfocus.org/research/symptoms/

Avoid coming up with your own theories for your symptoms. I spent a month worrying that I broke my ossicles, I actually had major fluid build up. Good research keeps you sane!

If you have TTTS induced by anxiety, like if your brain is somehow messed up and anticipates loud noises to be painful so your ear protection mechanisms are all messed up in anticipation of loud noises, can it be assumed that getting a handle of anxiety can help with those burning pains? (Ear affecting the nerves).

I've read TTTS is mainly anxiety induced. What else can cause the burning sensations often experienced by hyperacusis sufferers?

 

[MrCrybaby]

If you have TTTS induced by anxiety, like if your brain is somehow messed up and anticipates loud noises to be painful so your ear protection mechanisms are all messed up in anticipation of loud noises, can it be assumed that getting a handle of anxiety can help with those burning pains? (Ear affecting the nerves).

I've read TTTS is mainly anxiety induced. What else can cause the burning sensations often experienced by hyperacusis sufferers?

TTTS is influenced by anxiety, but it is the result of physiological damage to the ear. Otherwise everyone with phonophobia would have TTTS. The muscle, even in healthy people, does respond to anticipated loud noises. Anxiety plays a role but is not at all the whole story.

The ability of the ear to feel pain was only proven 5 years ago so there is an abysmal lack of understanding on why the pain is felt or how to stop it. I can't make any assumptions in this area.

All that being said, getting a handle on your anxiety will only serve to improve your quality of life so go for it!

 

[Tweedleman]

If the pill is just a high potency anti oxidant and free radical scavenger, shouldn't things like Astaxanthin and high dose vitamin C at least partially have the same response? There are no actual nerve growth factors in the pill.

Sorry to go back quite a few pages, but if I gobbled down a handful of Astaxanthin would it have any therapeutic benefit to my synapses?