Hough Ear Institute's Hair Cell Regeneration Project

[Mnq16]

I stumbled on below paper about Oblato and hearing loss / tinnitus pill NHPN-1010. If I read it correctly, the FDA approved compassionate use on patients:

FDA OKs expanded access program for HLB Therapeutics' tinnitus treatment candidate

It seems to me it is about the Hough Ear Institute pill. People from the United States may want to apply.

I don't know too much about this particular research but this is massive news, no?

 

[JPGL]

I stumbled on below paper about Oblato and hearing loss / tinnitus pill NHPN-1010. If I read it correctly, the FDA approved compassionate use on patients:

FDA OKs expanded access program for HLB Therapeutics' tinnitus treatment candidate

It seems to me it is about the Hough Ear Institute pill. People from the United States may want to apply.

What good news!

Is this pill for hearing regeneration? Is its mechanism of action known? Or is it at least effective in silencing tinnitus? Is it effective? What phase is it in? Does this news mean that they will release it shortly?

 

[Gb3]

Ok, it says they have begun to administer to chronic tinnitus patients? Would you have to travel or is this something my ENT can order?

 

[Clerkp]

Big day! To be clear, this is aimed at those of us with noise induced tinnitus?

 

[Brian Newman]

I stumbled on below paper about Oblato and hearing loss / tinnitus pill NHPN-1010. If I read it correctly, the FDA approved compassionate use on patients:

FDA OKs expanded access program for HLB Therapeutics' tinnitus treatment candidate

It seems to me it is about the Hough Ear Institute pill. People from the United States may want to apply.

Good find Mentos.

Also if anybody finds out the dosage they are using, I would greatly appreciate it. I heard 6 mg somewhere.

 

[Gb3]

To be clear, this is aimed at those of us with noise induced tinnitus?

I would assume any tinnitus stemming from cochlear damage.

 

[urgentresearch]

Something very, very strange about this NHPN-1010 story. I will share an update soon.

 

[ThomasC]

The mechanism of this drug is confusing. It is supposed to prevent noise-induced hearing loss, but it can also reverse cochlear nerve damages and tinnitus.

 

[AfroSnowman]

Something very, very strange about this NHPN-1010 story. I will share an update soon.

Grrr I think you might be right, I can't find any mention of it on FDA website, Hough Ear Institute, or on the Oblato website

 

[Xys87]

...the FDA approved compassionate use on patients...

The term "compassionate" means that there is no evidence that this treatment is effective for tinnitus. Is that right? Assuming it works, how soon could we benefit from this drug?

 

[Mentos]

The term "compassionate" means that there is no evidence that this treatment is effective for tinnitus. Is that right? Assuming it works, how soon could we benefit from this drug?

I'm not a native speaker but "compassionate use" for a drug means, for me, it can be given to patients, under certain conditions, even though it has not gone through the whole clinical trials process, since it has the potential to help with serious or life threatening condition. As I read it, indeed there is no proven evidence for drug efficacy, but there are some indications showing it may help. Otherwise I cannot see why FDA would grant such on option.

 

[ThomasF]

https://www.mayoclinic.org/healthy-...expert-answers/compassionate-use/faq-20058036

Compassionate use means it has been allowed by the FDA to be prescribed to people in need of such medicine. Even though it has yet to go through all trials. Implying at the very least it is safe to use for most cases and at the most it is effective, it just has to pass the gauntlet of the bureaucratic machine.

 

[Nobody19]

This looks like big news to me. Why isn't this news getting more attention?

Because it's Hough

 

[cjbhab]

Good news, hopefully it works - to me, a pill that reduces or eliminates tinnitus would be the best solution for sufferers if it works.

Congrats to whoever comes up with it. Enjoy being rich. Take my money. Take my car. Take my house. Take it all.

 

[DimLeb]

This seems very suspicious given there are no official announcements from the involved companies and even the FDA site...

 

[Sentinel]

Yeah about that.

So I called them at their public number, they were super nice and transferred me to the correct people. The lady who works at Hough Ear Institute told me that they are still in clinical trials and are currently undergoing a two-year study that will complete in September of 2022, at which point they have lined up a financier to fund them through Phase II-III (?) clinical trials. At that point, they said they have to define/decide whether or not the drug is going to be for tinnitus or hearing loss.

They said nothing about a compassionate use program, but who knows, that doesn't mean one hasn't been approved elsewhere. I guess we will see. I may be wrong and the person I talked to might only have access to a certain amount of information. She knew about this forum and was very eager to talk though.

 

[Brian Newman]

Yeah about that.

So I called them at their public number, they were super nice and transferred me to the correct people. The lady who works at Hough Ear Institute told me that they are still in clinical trials and are currently undergoing a two-year study that will complete in September of 2022, at which point they have lined up a financier to fund them through Phase II-III (?) clinical trials. At that point, they said they have to define/decide whether or not the drug is going to be for tinnitus or hearing loss.

They said nothing about a compassionate use program, but who knows, that doesn't mean one hasn't been approved elsewhere. I guess we will see. I may be wrong and the person I talked to might only have access to a certain amount of information. She knew about this forum and was very eager to talk though.

They said they are doing a two year study before they start Phase 2? This company is ridiculous. Man I remember when I first got tinnitus, this was one of the only companies creating a drug, and now it's going to be the last, literally. This company is one of the slowest companies I have ever heard of. If they did Phase 1 in 2014, how much longer do they need lol.

Gonna make us wait 15 years for this drug to come out. Seems like they're still not sure it actually works. Idk, I wish they had more data on it, not just mice testing. They need to speed things up.

 

[Justin De Moss]

Hi everyone,

@Markku asked me to jump on real quick and give everyone an update on the news article from koreamed.com.

I read through some of the comments and questions here. I will do my best today to answer them individually - but there are some "repeats" so be sure to check out all the responses. If I forget something - let me know. However, please note that my last day with Hough Ear Institute is officially December 3rd, while my last full day in the office is tomorrow.

To the article: HEI's CEO Dr. Rick Kopke was unaware of this article until I shared it with him. We did work with Dr. Kesari who wanted to seek approval for expanded use. The last Dr. Kopke was aware of was Dr. Keasri and Oblato seeking and receiving approval. However, Obalto did not have any of the drugs to offer the patient.

It appears from the article that may have changed, but we are unaware of it.

A colleague will monitor this thread after I leave and give updates as she is able. Please be nice to her

Justin DeMoss, M.A., CFRE

 

[Justin De Moss]

I stumbled on below paper about Oblato and hearing loss / tinnitus pill NHPN-1010. If I read it correctly, the FDA approved compassionate use on patients:

FDA OKs expanded access program for HLB Therapeutics' tinnitus treatment candidate

It seems to me it is about the Hough Ear Institute pill. People from the United States may want to apply.

Expanded Use is typically done on a case-by-case basis. Reading the article, it talks about "a chronic tinnitus patient." NOT patients, plural. To be clear

 

[Justin De Moss]

OMG. This is a big deal, right? Do we know whether this is supposed to be a single round of treatments or something that we'd have to take on an ongoing basis?

We don't know yet. The questions you are asking are generally found when dosing is determined, which is Phase II and III clinical trials.

Our estimation is that it would be a one-course treatment. That might be one pill or a month of pills. Our research suggests that once the nerve endings or regenerated into meaningful connections - they do not deteriorate. More research is needed to answer the question definitively.

 

[Justin De Moss]

What good news!

Is this pill for hearing regeneration? Is its mechanism of action known? Or is it at least effective in silencing tinnitus? Is it effective? What phase is it in? Does this news mean that they will release it shortly?

We have data on the pill's efficacy in pre-clinical trials for SNHL, ototoxicity, and tinnitus. We believe it might also be helpful with hyperacusis and Meniere's disease.

The pill helps absorb toxins/reduce inflammation and regenerate meaningful nerve connections between the cochlea and the auditory nerve.

Phase I clinical trials were completed in 2015. Too long ago! In February 2020 Oblato licensed the drug from OPI (commercialization partner) of HEI. We are all waiting on Oblato to determine which clinical indication they are going to pursue phase II clinical trials for. Phase II clinical trials typically take 1-2 years and cost $5-10M. Phase III clinical trials take 2-3 years and cost $50-100M.

 

[Justin De Moss]

Ok, it says they have begun to administer to chronic tinnitus patients? Would you have to travel or is this something my ENT can order?

Incorrect, the article says patient, singular. Not plural. We also are unsure how accurate this article is and are inquiring. Sometimes we are the last to know

 

[Justin De Moss]

Big day! To be clear, this is aimed at those of us with noise induced tinnitus?

Or blast-induced. There are probably several "causes" of tinnitus. We are going after the most prevalent one, at least what is thought to be the most prevalent cause.

 

[Justin De Moss]

The mechanism of this drug is confusing. It is supposed to prevent noise-induced hearing loss, but it can also reverse cochlear nerve damages and tinnitus.

Yes, the cause of one condition can be the cause of a second condition. So, the mechanism of how the drug works can have multiple uses. Also, the drug works in multiple ways.

We have data that indicates it works for SNHL, ototoxicity, and tinnitus. We believe it may be helpful for hyperacusis and Meniere's disease.

 

[Justin De Moss]

The term "compassionate" means that there is no evidence that this treatment is effective for tinnitus. Is that right? Assuming it works, how soon could we benefit from this drug?

The real term is expanded use.

Read more here:
https://www.fda.gov/news-events/public-health-focus/expanded-access

I'm not a native speaker but "compassionate use" for a drug means, for me, it can be given to patients, under certain conditions, even though it has not gone through the whole clinical trials process, since it has the potential to help with serious or life threatening condition. As I read it, indeed there is no proven evidence for drug efficacy, but there are some indications showing it may help. Otherwise I cannot see why FDA would grant such on option.

Read more here:

https://www.fda.gov/news-events/public-health-focus/expanded-access

 

[Justin De Moss]

Yeah about that.

So I called them at their public number, they were super nice and transferred me to the correct people. The lady who works at Hough Ear Institute told me that they are still in clinical trials and are currently undergoing a two-year study that will complete in September of 2022, at which point they have lined up a financier to fund them through Phase II-III (?) clinical trials. At that point, they said they have to define/decide whether or not the drug is going to be for tinnitus or hearing loss.

They said nothing about a compassionate use program, but who knows, that doesn't mean one hasn't been approved elsewhere. I guess we will see. I may be wrong and the person I talked to might only have access to a certain amount of information. She knew about this forum and was very eager to talk though.

Hi! I was in the room training the lady you spoke to. Let me clear up a few things that got misunderstood.

• NHPN-1010 is in a proof-of-concept study (2 years) before tinnitus will be considered for a Phase II study for the clinical indication of tinnitus. That doesn't mean Oblato can't move forward with another indication in the meantime.
• I wouldn't say we lined up a financier. Our business model is to do initial, pre-clinical, and maybe some clinical research to attract for-profit biotech firms to take our research through any remaining clinical trials. Oblato is a biotech firm, not a financier/venture capital group. We are a non-profit so we can't pay dividends on donations
• She did say a decision would have to be made, but that can be done at any time. I doubt they will make a decision before this 2-year proof-of-concept study is finished because they do not have all the data.
  • I'll post more on the proof-of-concept study with our current milestones.

Thank you for the kind words about my collegaue! We hope to bring you relief.

 

[Gb3]

@Justin De Moss, so can you confirm that Dr. Kesari was working with the drug? The article does state that he saw efficacy with the drug having a therapeutic effect on tinnitus.

 

[Justin De Moss]

They said they are doing a two year study before they start Phase 2? This company is ridiculous. Man I remember when I first got tinnitus, this was one of the only companies creating a drug, and now it's going to be the last, literally. This company is one of the slowest companies I have ever heard of. If they did Phase 1 in 2014, how much longer do they need lol.

Gonna make us wait 15 years for this drug to come out. Seems like they're still not sure it actually works. Idk, I wish they had more data on it, not just mice testing. They need to speed things up.

To speed things up takes money. We are a non-profit that relies on government funding and private donations. The two-year proof-of-concept study has several objectives. I will post what milestones we have accomplished in another post.

To help you better understand what is happening, imagine you run a biotech firm, and 1 out of 10 trials you furnish will fail. Now, HEI comes to you with a drug that has data to support it with SNHL, ototoxicity, and tinnitus. As a biotech firm and part of the FDA approval process, you have to pick one clinical indication to fund for each trial. You can run three trials at $10M a piece or you can collect all the pre-clinical data you can and make an informed decision, reduce your risk of loss, and intentionally choose the indication that is most likely to get FDA approved.

The POC study was requested to see if it worked on chronic tinnitus, to have a larger study done to see if it still works, and other factors - before the Biotech firm decides where to invest $10M; in the clinical indication of tinnitus or some other indication.

You can see that they can move forward right now with any indication they want. They are choosing to play it safe. Also, FYI, the POC study costs $735,000. $300K was supplied thanks to the state of Oklahoma through an OCAST grant, and $300K from the biotech firm.

If you ask me - that says all anyone really needs to know about the science and HEI. We are real researchers, doing real research, for real solutions. If you think non-profits can just get grant money from the government without good science - you are mistaken.

 

[Justin De Moss]

@Justin De Moss, so can you confirm that Dr. Kesari was working with the drug? The article does state that he saw efficacy with the drug having a therapeutic effect on tinnitus.

Keep in mind this was an article written by a reporter. They don't always get the facts straight. Before we got connected to Dr. Kesari were already working on funding this POC study because we already had pre-clinical data that indicated the pill's efficacy on tinnitus. Dr. Kesari was introduced to me back in June 2020 give or take. I introduced him to Dr. Kopke. They talked and that was the last I heard of it until now.

The article makes it think that Dr. Kesari suggested that this would work for tinnitus and I'm sure the reporter just misunderstood their source. We have known about its potential efficacy with tinnitus for much longer than Dr. Kesari has been involved with HEI, OPI, Auditus, and Oblato.

Until I hear back from Dr. Kopke - I can't confirm that Dr. Kesari is working with the drug.

 

[Justin De Moss]

This is a report from our COO of HEI and our research team on the milestones this year with our proof-of-concept study:

• We were able to develop a unique model of noise-induced neurodegeneration that does not result in permanent hearing loss but does evoke a chronic tinnitus percept.
• This is allowing us to study the impact of nerve ending loss on this auditory disorder without the confounding element of sensory hair cell loss or clinical-grade threshold shifts.
• We also discovered that the nerve ending loss induced by this noise exposure is rapid and occurs within the first 24h after an insult of this type.
• The ensuing nerve ending loss is permanent without treatment.
• These findings have marked implications for recreational and occupational noise exposures that induce subclinical degrees of cochlear nerve damage and which may account for permanent loss of hearing acuity (speech-in-noise, i.e. trouble hearing in a crowded room) and the inception of auditory disorders, such as tinnitus, when normal hearing function is seemingly preserved.
• We are now performing a series of testing regimens to determine if our therapeutic technology can prevent or reverse this type of auditory nerve damage.