Hough Ear Institute's Hair Cell Regeneration Project

[Rb86]

Just letting you all know... Per email conversation, funding has not reached all the way to the goal, but it is now close enough that they're starting their proof of concept study for tinnitus TOMORROW!!!!

 

[DebInAustralia]

Just letting you all know... Per email conversation, funding has not reached all the way to the goal, but it is now close enough that they're starting their proof of concept study for tinnitus TOMORROW!!!!

Yes, Justin emailed me that last night. Great news! Do you know how long this proof of concept study will take before we have something more concrete to hope for?

 

[Rb86]

Yes, Justin emailed me that last night. Great news! Do you know how long this proof of concept study will take before we have something more concrete to hope for?

I sure don't. But it's my hope that this trial will serve our community really well, because Frequency Therapeutics is only testing for hearing regrowth and not really focusing on tinnitus like this trial will do. I'm hoping we have direct information on how people's tinnitus reacts to this drug.

 

[BBakkers]

I sure don't. But it's my hope that this trial will serve our community really well, because Frequency Therapeutics is only testing for hearing regrowth and not really focusing on tinnitus like this trial will do. I'm hoping we have direct information on how people's tinnitus reacts to this drug.

So where can we find the link to this clinical trial?

 

[Brians81]

This great news. I hope we will hear about this proof of concept study on tinnitus and I hope this treatment may help us all. Praying to God for this miracle to happen

 

[Nobody19]

I sure don't. But it's my hope that this trial will serve our community really well, because Frequency Therapeutics is only testing for hearing regrowth and not really focusing on tinnitus like this trial will do. I'm hoping we have direct information on how people's tinnitus reacts to this drug.

Frequency Therapeutics is also testing the effect of their drug on tinnitus, but their main focus is hearing regrowth.

 

[weab00]

Can someone provide a link for the commencement of Phase 2 for the pill? The only thing I can find is the copy paste on this forum. Is there at least a screenshot or something?

 

[Thuan]

Can someone provide a link for the commencement of Phase 2 for the pill? The only thing I can find is the copy paste on this forum. Is there at least a screenshot or something?

You can do an advance search on ClinicalTrials.gov and search by Sponsor with Hough or Oblato or Auditus (the latter two are partners with Hough). So far, I have found no clinical trials regarding hearing loss or tinnitus by any of them.

It would be really nice if Hough could post an update on their Hough Ear Institute website if they're starting clinical trials on their advertised "Pill", and especially including a direct link to ClinicalTrials.gov.

 

[Rb86]

Frequency Therapeutics is also testing the effect of their drug on tinnitus, but their main focus is hearing regrowth.

Are they though?

I recall from Tinnitus Talk Podcast when asked about tinnitus, that Carl LeBel said they aren't testing for that, but that one or two patients mentioned to their ENT doctor that the tinnitus had improved during the trial.

 

[Rb86]

To my knowledge, Hough Ear Institute is doing a proof of concept study to show the pill is effective for tinnitus, so that investors will feel it is worthy of spending money on clinical trials. I don't know how they're doing the proof of concept. I don't know if that means humans or not.

I'll email Justin De Moss and see if he can answer that here.

 

[Nobody19]

Are they though?

I recall from Tinnitus Talk Podcast when asked about tinnitus, that Carl LeBel said they aren't testing for that, but that one or two patients mentioned to their ENT doctor that the tinnitus had improved during the trial.

https://clinicaltrials.gov/ct2/show/NCT04120116?term=frequency+therapeutics&draw=2&rank=1

Secondary Outcome Measures :

Tinnitus Assessment [ Time Frame: Screening to Day 210 ]
Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.

 

[GregCA]

To my knowledge, Hough Ear Institute is doing a proof of concept study to show the pill is effective for tinnitus, so that investors will feel it is worthy of spending money on clinical trials.

What's the difference between a "proof of concept study" and a "clinical trial"?

 

[Kendra]

What's the difference between a "proof of concept study" and a "clinical trial"?

I believe (could be wrong) a proof of concept can use animals or other means to show it has the potential to work. While a clinical trial needs to be done on humans to show it works and is usually the next step.

 

[Joeseph Stope]

The big unanswered question is of course: "Will this work for chronic tinnitus (i.e. more than 3 … 6 months duration)?"

 

[urgentresearch]

Yes, Justin emailed me that last night. Great news! Do you know how long this proof of concept study will take before we have something more concrete to hope for?

I am confused and I wonder if the term "proof of concept" was used too loosely here. (In drug development, proof of concept has a specific/narrow meaning that is separate from proof of mechanism or proof of of principle.)

 

[urgentresearch]

And today, I'm proud to tell you that we are closer than ever! Our proprietary hearing loss pill is entering phase 2 FDA clinical trials, and we have so much more in the works.
Chief Philanthropy Officer

This is the confusing part.

What does "is entering" mean here, exactly?

I think it is important for statements like this to be much more clear... especially when they are presented in the context of a fundraising email (due to the legal implications that arise when soliciting funds).

 

[weab00]

What I don't understand is why Justin would personally tell several select people that they are starting phase 2 clinical trials as well as the tinnitus "proof of concept study" via email without Hough first putting out an official announcement—it muddies the news. This is clearly an issue of communication; the only source we have right now is two 3rd-hand statements from TinnitusTalk users, so I don't know if we should be celebrating quite yet (not that I think anyone is lying, but let's tread carefully).

 

[Justin De Moss]

@Justin De Moss,

@ajc and @tommyd87 did misinterpret the answer regarding the off label use.

Post #966 and specifically at the quoted answer at part 6, which was talking about off-label use not covered by insurance and that it would put "medical license in jeopardy":

6) If prescribed off label and/or the insurance company doesn't cover it because the study wasn't objective, rather subjective for example, then a patient could take it - for any reason they wanted to assuming that a) their Dr. is willing to write a script for the drug for an indication that the drug has not been approved for (and thus potentially putting their medical license in jeopardy) b) they don't mind paying the full market value of the drug - which can be thousands if not tens of thousands of dollars.​

My interpretation is that it can be used off-label but doctors' might be not willing (due to the nature of off-label use jeopardizing medical license but is entirely dependent on the doctor's choice) and if the doctors are willing, then it concerns about insurance coverage.

I see that some people can misinterpret assumption "A" regarding off label use can put doctor's "medical license in jeopardy" as an interpretation that it can not be used off-label.

Expanding on the general confusion:
@tommyd87 main concern, and probably the general consensus, is that the extra tinnitus study is unnecessary when a clinical trial for hearing loss is being conducted because the general assumption is that curing hearing loss cure tinnitus (but that has not yet been proven so everyone's just banking on this assumption).

Personally, I would be in favor of a tinnitus study once the hearing loss trial show positive results in phase 2. If it does show positive results from the hearing loss study, then I think it would be necessary to do a tinnitus study. The issue is that it would be an entire waste of both money and time if the hearing loss study do not show positive results. Again, the assumption is the correlation between hearing loss and tinnitus. Based on that assumption, if it shows no efficacy regarding hearing loss, then it would be unlikely to help tinnitus and thus prematurely conducting hearing loss study and tinnitus study at the same time is jumping the gun.

@Justin De Moss Thank you for your interaction and discussion at Tinnitus Talk.

With that being said, I can understand everyone's frustration at the slow pace of things. As someone who had mild tinnitus developing into moderate tinnitus 3 months ago, I'm also desperate and impatient to push for fast results. We're all impatient that a tinnitus study is needed to be funded when a hearing loss study is already green lit.

Thank you for doing the research and putting this together.

I agree - research is frustrating because it takes so long. Whenever we are frustrated or suffering, the character of a person is in how they respond. Character = civility.

 

[Justin De Moss]

To my knowledge, Hough Ear Institute is doing a proof of concept study to show the pill is effective for tinnitus, so that investors will feel it is worthy of spending money on clinical trials. I don't know how they're doing the proof of concept. I don't know if that means humans or not.

I'll email Justin De Moss and see if he can answer that here.

The PoC study is to test an objective measurement of tinnitus as well as to see if it works for chronic tinnitus. All of our previous studies indicated that it does, but for chronic tinnitus, the sample size was a little on the small side. Yet, we did have statistical significance.

The biotech company agrees with us, hence the reason they are funding nearly half the study to find out if it is worth the millions to run a phase 2 study. If successful - this will be the first phase 2 study that has as it's PRIMARY objective the treatment of tinnitus. It will also be the first, to my knowledge, of objectively measuring tinnitus.

 

[Justin De Moss]

https://clinicaltrials.gov/ct2/show/NCT04120116?term=frequency+therapeutics&draw=2&rank=1

Secondary Outcome Measures :

Tinnitus Assessment [ Time Frame: Screening to Day 210 ]
Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.

I wish Frequency Therapeutics the best. We are different in our approach and in what causes tinnitus. We both might be right! It's good to have several approaches in the pipeline.

One difference between Frequency Therapeutics and Hough Ear Institute is that we hope to run a phase 2 study that has tinnitus as the primary goal/finding, not secondary. The second is objectively measuring results v. a self-report style which is extremely unreliable depending on sample size.

 

[Justin De Moss]

What's the difference between a "proof of concept study" and a "clinical trial"?

A PoC study is like a pilot study if you will. Before the biotech company spends millions of dollars for a phase 2 study for another indication, they desire to see some additional results from a larger than already done, but small than phase 2 study.

In a lot of respects that is what Frequency Therapeutics has done with their phase 2a. Phase 2 studies involves hundreds of patients, not tens of patients.

It's a good strategy to raise venture capital. I hope they are successful.

 

[Justin De Moss]

The big unanswered question is of course: "Will this work for chronic tinnitus (i.e. more than 3 … 6 months duration)?"

That is the question the biotech firm has. Before spending millions on a phase 2 study they want some more data.

 

[Justin De Moss]

This is the confusing part.

What does "is entering" mean here, exactly?

I think it is important for statements like this to be much more clear... especially when they are presented in the context of a fundraising email (due to the legal implications that arise when soliciting funds).

First off, Hough Ear Institute doesn't run the study. I'm not sure why people keep thinking that we do but we don't. The biotech company does. They will choose whatever indication they want to study. They can choose one, two, three, etc.

To be clear - Phase 1 is complete. Phase II is funded and ready to start once they determine which indication(s) they want to do. Additionally - we are doing a proof of concept study because the biotech company has a desire to do a tinnitus phase 2 study as its primary objective.

There are obviously some delays due to the global pandemic. How much of a delay - no one knows. Hopefully, phase 2 starts this year still. That will NOT be for tinnitus. The PoC study has to be done first before they will consider spending the money for a clinical 2 study for the indication of tinnitus.

 

[Justin De Moss]

What I don't understand is why Justin would personally tell several select people that they are starting phase 2 clinical trials as well as the tinnitus "proof of concept study" via email without Hough first putting out an official announcement—it muddies the news. This is clearly an issue of communication; the only source we have right now is two 3rd-hand statements from TinnitusTalk users, so I don't know if we should be celebrating quite yet (not that I think anyone is lying, but let's tread carefully).

First off, if I said "we are starting phase 2 studies" that was a miscommunication. Hough Ear Institute doesn't run the trials. The biotech company, Oblato, who has exclusive license to the drugs will be running them. The process has started for a phase 2 study. There is a lot to the process.

It's best not to read into what is said. Context is important. Because the process is started, doesn't mean that we are already at a point of selecting candidates for the trials Sometimes I say we have started and "we" have, as in Oblato. Sometimes I say they haven't started because of the context - people are wanting to sign up. That part has not started.

Does that make sense?

 

[Justin De Moss]

I agree, however most patients (especially those outside America) actually aren't eligible to get the treatment through the insurance anyway. Thus while I would wholly agree that doing the study is not moot it isn't as beneficial for many as you may think.

For example, I would need to pay the actual full retail amount if I obtained it in America. Alternatively in Australia I'd need to do the same, unless they subsidise this through the pharmaceutical benefits scheme. This is where our government pays for or covers a significant portion of a number of medications.

Thus the pill's release is possibly a bigger priority for majority of candidates than it being covered by insurance.

FDA approval often leads to a fast track with other country's equivalent to the FDA.

Also, it fits in our mission. We can purchase the drugs and through our humanitarian efforts - deliver it to those in most need. Our founder and doctors have been to over 80 countries offering their services and medicine for free. But we have to have FDA approval first.

 

[Justin De Moss]

Just ask Justin De Moss to come back to Tinnitus Talk, he had already answered many questions here before.

He really needs to clear the waters, Hough is appearing like a scam almost now... all the contradictory information and miscommunications is really hard to swallow.

@ajc - Thaun cleared up your previous statement in this thread already. I suggest you go back and read it to see how you misinterpreted it.

 

[Justin De Moss]

It's possibly not the case but I feel like Oblato and Hough have confidence it works for the hearing loss side but don't have confidence that it works for tinnitus. Thus the burning question is why won't Oblato fund this on their own or at least the rest of it if they are absolutely keen to investigate tinnitus.

@Hazel would you be interested in setting up another discussion with Hough.

There is more data for hearing loss (cochlear implant trauma, NIHL, ototoxicity) than for tinnitus. It has nothing to do with confidence. The PoC study costs $735K. Oblato is paying for $300K of it, the state of Oklahoma is paying for $300K of it. That leaves $135K for us to raise for it. I'd say a lot of scientists are pretty confident in the work.

Your burning question is actually a false assumption - they are paying, for nearly half of it!

 

[Justin De Moss]

Once Hough collects money for the proof of concept study, how much time is needed to start the phase 2 for tinnitus?

PoC study will take a total of about 12 months. We should finish by next September. Then it will probably take some time, unknown, for Oblato to decide whether or not they want to run a phase 2 study for the pill for the indication of tinnitus as the primary objective.

 

[Justin De Moss]

@Justin De Moss I haven't read the others' apparently disrespectful posts but let it roll off your back.

I can tell you all I've had numerous emails with Justin and he gives a shit. Genuinely. I've also been the frustrated hopeless and angry guy on here too.

I honestly get both sides. We need a cure yesterday and it's hard to pull off. Really hard.

Continue to fight the good fight. Putting a dent in, if not curing tinnitus would be one of the most righteous feats for mankind the world over.

Anxiously waiting.

I don't take it personally. I do however take it professionally when someone accuses me personally and the staff/researchers at Hough Ear Institute as liars. I get people get frustrated. I get frustrated. Heck, you got frustrated with me. But while frustration is expressed, it was always civil.

It is quite offensive to see someone make such comments based on their misunderstanding about a group of people who have dedicated their lives to restoring hearing. Hough Ear Institute is co-responsible for the Cochlear implant, many surgeries that recover hearing, a lot of tech in hearing aides, and now some of the first pharmaceutical treatments for hearing loss and tinnitus, hopefully!

Thank you Rob. I do care. It's a Holiday weekend and I'm on my Mac responding to comments and helping to clear the air where it is muddy. I have tinnitus and it is getting worse. I also believe in this research and this team. I have put my money where my mouth is as I am one of the top 10 donors to Hough Ear Institute. I don't say that to brag, but to say I got skin in the game.

I can say that we have received lots of donations thanks to the Tinnitus Talk community. I don't recall the largest donation amount, but I'm pretty sure it isn't over $500.

The skin I have in the game is a top 5 figure gift. Again, not bragging - but I do care and I want this to be successful.

 

[Justin De Moss]

Just letting you all know... Per email conversation, funding has not reached all the way to the goal, but it is now close enough that they're starting their proof of concept study for tinnitus TOMORROW!!!!

Started September 1st. Yay!!!!!

We will reach the rest of the goal before the end of the year hopefully!