Hough Ear Institute's Hair Cell Regeneration Project

Aaaah, you mean the HPN-07 has to be transported under these temperatures as well?
What do they use to transport it usually?

 

What would the regimen look like? Do you take it one time or for a month or something?

 

Wrap the bottle in popsicles.

 

Frequency Therapeutics applied for Fast Track for their FX-322. It’s in the prospectus of their IPO. They probably used (among other things) the link between hearing loss and dementia.

 

Hi Mr. @Justin De Moss. First and foremost, I want to thank you for your interaction with this community. I think this in itself, is a major victory for the organization you represent.

I have a rather specific question and will try to keep it as non-technical as possible. I won't cite specific research, but feel free to ask for it (anyone).

I, myself, have tinnitus with a normal audiogram (pre vs. post tinnitus). My tinnitus had its onset in an era where it was a rather unknown affliction. So I had an audiogram done and was 'cleared'. And seen that I was 16 years old at the time, the ENT gave my mom some placebo pills that would resolve my 'problem' within two weeks (after he had a talk with her in a separate room).

Anyways, a few years have passed. And the so called 'hidden hearing loss' is a little bit more established, but still often overlooked in both diagnosis and research, at least that's the feeling I get reading through whatever 'science' produces. However, I do have to say, 2018-2019 has proven to be a time where the lack of knowledge and effort in this area is recognized. Either way, some important takeaways from the research:

First, hidden hearing loss can somewhat be defined by hearing loss that is not recognizable on an audiogram and is expressed by having trouble to discriminate sound (eg. voices) in noise (eg. a bar).

Secondly, the body of research seems to hover towards the fact that hidden hearing loss can be (and often seems to be) a consequence of neurodegenerative activity in the cochlea, and more specifically, the loss of ribbon synapses of the hair cells.

Thirdly, research has pointed out that this neurodegenerative impact on the synapses happens sooner than the impact on the hair cell itself. So when we see a temporary threshold shift caused by temporary damage to hair cells, research has established that we have, in fact, permanent damage to synapses connecting those hair cells. Moreover, the autoregenerative capacity the synapses is posited to be inadequate and insufficient. I guess some logic reasoning (un-sciency, I know) might point towards the these that because of the sensitivity of the synapses, they actually degenerate (die) sooner than the hair cells themselves. And, a fortiori, when a hair cell is lost, the synapses are all lost too.

Fourthly, early (cursory) research (research on this subject only recently started to get some traction) seems to indicate that while hair cells can be regenerated, the synapses are often, if not always, not or very inadequately regenerated.

Fifthly, research indicates that hidden hearing loss still can go by unnoticed on an audiogram with a synaptic loss of less than 80-90%.

Sixthly, hidden hearing loss, and the synaptic loss, is in fact very difficult to diagnose objectively in vivo. Thus, it is even more difficult to establish whether or not the hidden hearing loss has improved.

Seventhly, it seems that hidden hearing loss can be the underlying cause of tinnitus.

These takeaways beg me to ask the question. How does your research take synaptic loss into account? Because in the research on the website of Hough I can't really find an indication. And following from the above, an objective improvement of the auditory threshold doesn't necessarily mean an improvement of the hidden hearing loss and consequently, might not impact tinnitus all that much.

It's midnight here right now and I probably forgot a bunch and misphrased/made some mistakes. But I wanted to get it off my chest, because the professionals seem to care more about the hair cells than the rest. I have this feeling that they are going to fix the computer without fixing (or plugging in) the power cable.

 

Yes, but we continue to work on it as well as a hair cell regeneration injection. Plus a new novel inner ear drug delivery that opens the door to treating genetic mutations in the ear.

I hope to be able to share some great news soon about the Phase II trial for the pill!

 

Fund the research. 100s of millions go into funding cancer, heart disease, etc. privately. The adage that the squeaky wheel gets the grease is all too true here.

 

Good afternoon! The short answer to your question is that the pill we are working on regenerated meaningful nerve connections between the cochlea and the auditory nerve. The key here is meaningful connections - where the synaptic connection are re-established in a way that allows for hearing recovery. Because clarity of hearing (what people lose with hidden hearing loss, and with acquired hearing loss) is restored with the pill - I believe it may be of great benefit to you and others too.

Likewise, one of the prevailing theories of the cause of tinnitus is the same lack of connection in the ribbon synapses. We ran three models on animals and we achieved amazing results in treating, even curing tinnitus.

I hope that answers your questions well. If not, let me know or say, "What the heck are you talking about?" I won't be offended. I'm learning a lot from you guys!

 

Don't know yet. Dosing is established in Phase II clinical trials. Hopefully, we start in the next 6 months!

 

Donated some $$s. Is this the way to early access? Can you send me the Pill?

 

I am already a patient at Hough. I have ties to OK and am willing to travel. How can I be part of this trial?

 

Why can't you start tomorrow? FDA rules?

 

More likely funding.

 

@Justin De Moss

Correct me if I'm wrong. I seem to recall reading that Hough Ear Institute has a 7 year patent on their mechanism and the next step is to attract a larger biotech company to take on the drug and support clinical testing.

I was talking to my dad about this (who has spent is life in pharmaceuticals, seeing drugs through infancy to market) and he was saying 7 years is not nearly long enough a patent to attract the large biotech companies. He said, whether necessary or not, they much more often like to see 15-20 year parents so that they can maximize profits on the back end after the usual 10 years of clinical testing.

Hopefully, should we see more results, Hough Ear Institute can extend their patent.

 

@Justin De Moss

Not too sure if this has been answered yet or not but... If Phase 1 ended in 2015 why was there a delay in starting Phase 2? You could have been in Phase 3 or entered the market by now?

 

More evidence that the system is entirely broken and made to serve profits and not people. Suffering people. It's almost like they see us a sheep to be fleeced, cattle for meat.

 

Thank you for answering all our questions. I was wondering what Hough’s thoughts are on the limitations of intratympanic injections. I’ve read that it limits the bioavailability of the drug in the cochlea, both because there’s a chance of drug leakage through the eustachian tube and because of individuals’ lack of permeability of their round window membranes and/or because some drugs have a particular hard time permeating. The result seems to be that it’s hard to get enough of the drug in the cochlea, let alone that drug reaching the apex of the cochlea where the lower frequencies are.

There’s been a lot of discussion in the literature about the delivery method being crucial for these upcoming hearing loss drugs so I would love your thoughts on that, particularly because you are developing your own intratympanic delivered drug. Are you considering trying novel delivery methods that have advantages over intratympanic injections in terms of bioavailability, like intracochlear injections or nanoparticle delivery?

 

A pill that is safe and effective, while I suffer every minute of the day... Why can't I try it...

 

I know it's tough but try to hang in there, we're in this together.

 

I dunno if I should open Pandora's box but I work for a company that sells products like this B2B. This particular one is not in our catalog but it probably will be eventually.

 

We still have to stick to policies unless there is a backdoor sales ....

 

Wait a minute. I'm not trying to be rude, but @Justin De Moss, if you yourself have tinnitus and the pill has been proven safe and effective. What is stopping you from trying it yourself? I mean, you actually work for the company. Wouldn't it be easy for you to try it, and then you will know without a shadow of a doubt whether or now it actually works.

 

I'll give him a chance to answer since you asked him, but, if he did (I would) he wouldn't be legally allowed to tell us and it would mess up the process of getting it out to us. Maybe he did try it and it cured his tinnitus but he just cannot tell us, but he has extreme confidence. Same with people that may have had BDNF and NT-3 treatments.

 

@Justin De Moss how do I donate to your company?

 

I don't think it's been tested on humans yet, let alone dosing figured out.

 

https://houghear.org/ -> right top: donate...

 

It has. They did a phase one on humans.

 

HPN-07 has been tested in multiple trials for multiple purposes. I have the impression it is not exotic as it has many synonyms:

ARL-16556
CPI-22
CXY-059
Cerovive
Disufenton sodium
NXY-059
OKN-007

It gives the feeling of yet so close, yet so far

 

Ah ok. Thanks.

 

Shall we all play Euromillions and donate if we win?