Hough Ear Institute's Hair Cell Regeneration Project

English is not my first language, but if I understand correctly, they don't know if their pill could help chronic sufferers but their pill helped someone who had had tinnitus for a month. Am I right? If that's the case, I'm not sure that one month would be considered chronic.

 

Great news!

Even if this only heals acute damage, knowing that my tinnitus and hyperacusis can never get worse would be a huge relief.

 

Considering @Justin De Moss’s compelling personal interest and some other evidence from the rest of the interview it really sounds like they intend to get this to market as quick as possible. I’m sure Oblato wouldn’t disagree.

 

From the interview, "mid decade" could mean 2024, it doesn't have to mean 2025 or 2026.

It sounds like (and maybe Justin can clarify), that timeline is factoring in a possible 2nd phase 2 (phase 2b?) where they address tinnitus and hidden hearing loss. Per the podcast and this press release (linked below), it sounds like acute hearing loss will be tested first. I would love to know if anyone else has a different interpretation, though.

https://www.prnewswire.com/news-rel...hough-ear-institute-scientists-301003204.html

 

If it doesn't regenerate hair cells, should this thread be retitled?

 

Their pill doesn't but their RNA silencing compound in pre-clinical does.

 

Oh, thanks! I haven't been able to hear the podcast due to the internet being down after the EF1 hit my neighborhood. Hoping to get it back tonight, though it will probably be tomorrow.

 

It sounds like that compound might not even selectively regenerate the hair cells, but rather anything that is damaged within the cochlea. Super neat bonus content.

 

Where did you see that?

 

In fact because there are two candidate drugs running, this thread should be split in two threads.

 

Well... Definitely, I would need to read the transcript, my listening to English is really bad. I haven't even heard that.

 

Injection: Hearing Loss Regeneration (regenerates hair cells)

• silencing RNA (siRNA) technology that regenerates the inner ear hair cells destroyed by noise-induced hearing loss
  
• changes supporting inner ear hair cells into sensory hair cells essential to hearing, most supporting inner ear hair cells don't multiply before changing
  
• still preclinical

Pill: Hidden Hearing Loss / Prevent Hearing Loss after loud noise exposure (regenerates synaptic connections between the hair cells and the auditory nerve)

• has the ability to regenerate and reconnect damaged nerve endings on surviving hair cells
• OPI led a successful Phase 1 clinical trial to demonstrate safety in 2015 (tested in healthy human subjects)
• source: Fig. 29 shows NHPN-1010 treatment (HPN-07 plus NAC) restored IHC ribbon synapse numbers in established, chronic hearing loss model. NHPN-1010 treatment was initiated 4 weeks after injury and dosed daily for 14 days. Ribbon synapse counts were significantly restored 8 weeks post-injury (tested in mice)
• Phase 2 to begin 2020 to evaluate the potential of the drug to prevent and treat hearing loss, may also be tested on people with chronic tinnitus (for off-label use for tinnitus patients
  • in the article it says "Follow-up studies may test efficacy for treating tinnitus and improving ability to understand speech in the presence of background noise"

 

They haven't tested in humans yet in terms of efficacy. They did the phase I safety test on healthy subjects so no indication on whether it works in humans as of now.

The one month tinnitus test was done on mice models.

 

@Justin De Moss: many thanks to you and Dr. Kopke.

Just out of curiosity, is there a link (or a PDF file) to the medical publication (I mean the full article detailing the results) related to the phase 1 clinical trial? https://clinicaltrials.gov/ct2/show/NCT02259595

I quickly browsed:
this thread,
https://houghear.org/publications/
http://otologicpharma.com/selected-publications/

I did not manage to find it.
Edit: I did not find Oblato Biotech website either.

 

I truly hope they begin recruiting for Phase 2 ASAP! Additionally, I hope they will host clinical trials in the Northeast. Some of, if not all of my problems could be solved this year... or is that wishful thinking?

 

It sounds like this year they are recruiting acute noise patients only. With hopes for further studies (tinnitus, synaptopathy) later. I'm not totally sure about this, though. @Justin De Moss, is this right?

 

Hello everyone!

First, thank you all for your support, your patience, and your understanding! I'm writing to you from home because last Friday I got the flu, then it turned into two ear infections, a sinus infection, and pneumonia. I mention that because since this all started by tinnitus has been constant and really impacted me more like what many of you describe. I believe I had empathy towards y'all before now, but I can say for certain that I know what you are going through.

The Phase II design will be determined by Oblato. I believe they are checked for the pill's efficacy on cochlear implant trauma. 1) Because it is easier to objectively test for, and 2) that pathway leads to the fastest way to get the drug approved by the FDA.

That said, we haven't given up on the tinnitus piece of the equation. There is interests in conducting a Phase II study for the indication of tinnitus. To do that, however, they have asked us to do a proof of concept study to show that we can objectively measure efficacy in a Phase II trial. So, when we raise the money necessary for it - we can hopefully add it to the list of indications to be treated with the pill.

Why is it important to do this? To get it into the hands of patients faster. A drug can be prescribed off label, but many insurance carriers won't cover off-label scripts. Which means people would have to pay the full price of the drug until that has been established.

Hope that helps clear the things so to speak.

 

Not to my knowledge. I will see if that is available.

 

@FGG it appears I’m wrong, thanks Autumnly (srs). So their injection tech would better be compared to Regain than FX-322. Super cool that the pill can regenerate the connections between healthy hair cells and the damaged nerve endings. If I remember correctly, this was one of @brokensoul’s primary concerns about scope of regeneration tech.

 

Thanks so much for answering our questions.

Does this mean that tinnitus would included in a potential phase 2b after the cochlear implant injury study if you can raise funds for a proof of concept study?

Or will the aim be to release this drug with the indication of protecting against injury due to CI insertion so it can be released faster with off label studies being done later?

 

I wouldn’t wish this on my worst enemy, let alone someone who is so proactive and engaging in our community. Ear-infection-induced/exacerbated tinnitus looks like it has close to the best recovery outcomes (coming from someone whose obsessively read the success stories at least three times over in efforts to cope). Hopefully this will be just a blip on the radar few months from now. Are you on any antibiotics? Some are more destructive than others. @FGG might be able to shed some light on that.

Good luck man. We appreciate you.

edit: one thing that’s interesting about this $735k proof of concept study for tinnitus is that the sole reason for this would be so that those with tinnitus could have this prescribed with approval by insurance. I inquired about the same application for insurance approval in the FX-322 thread since they are currently able to do so in a separate experimental arm, although it seemed like the consensus was that even if it showed considerable efficacy for tinnitus in the experimental arm, that it would have to be prescribed off-label for tinnitus and thus unlikely to be approved by insurance. Any thoughts?

 

I hope you recover quickly, sounds bad. Thanks for all the work you are doing.

I would love to know approximately what the full price of the drug would be. Here's hoping you can get it onto the market as soon as possible.

 

Lol. He doesn't need my advice on antibiotics, he has Kopke .

 

If this pill worked I could care less about paying off label price. I would find a way for the VA to pay for it, and they can have their monthly debt to me cancelled.

 

I can't believe I have read again that funds have to be raised, and we need to wait while there is suffering. I believe many of us could potentially help help this kind of research if only we were given an opportunity to do so.

I wish it was more accessible for us like Kickstarter campaigns. I can't believe I am able to fund some flying pet bicycle pocket device project but I cannot fund myself a drug that can potentially improve or even save my and others life.

 

Hey, can Hough Ear Institute's pill help age-related hearing loss?

 

I found that shocking.

I thought with the new partnership with Oblato they have the funds for the clinical trials.

Do they actually need more funding?

 

They need $735k specifically for it to be potentially labeled as a tinnitus treatment, for insurance access.

Without it you’d be able to get it prescribed but would have to pay out of pocket.

 

I read that a little differently.

My understanding is that by limiting the initial Phase II trial, and making it easier to earn FDA approval, there is a greater likelihood of bringing the drug to market as soon as possible.

Then, once approved, it can be prescribed off-label so tinnitus-sufferers will at least have access while waiting for a mop-up trial to potentially enable insurance reimbursement - if it works.

The alternative, that the clinical trial is overly broad means that even if the drug is successful for some indications, it can stall out and get delayed by years or worse.