Inner Ear Hair Cell Regeneration — Maybe We Can Know More

[Jim51042]

There are still many things we don't know about this pill:

Do we know the Pill's name? Do we know an estimated Phase 2 schedule? Has there been or do they expect a Phase 1 paper coming out? If so when?

 

[GregCA]

But I've read somewhere in this thread that damaged hair cells could potentially survive for years (I think)...

I don't know about hair cells but hearing nerve endings that can potentially reconnect to hair cells seem to stay in place for quite a while (I posted a few months ago about a guy getting a cochlear implant after decades of deafness, and the electrical stimulation was still able to make its way to the nerve from the cochlea).

 

[jay777]

A pill. Am I dreaming?

 

[PetitGarsTimide]

From the video, starts at 2:40
Pill - Hidden Hearing Loss & Tinnitus

• a pill that in preclinical models seems to be very effective at treating tinnitus (not mentioned whether acute and/or chronic t)
• seems to regrow the nerve endings in the inner ear
• may be able to restore hearing
• has been through Phase 1
• ready for Phase 2

Can someone give this man a xanax pls

 

[ee9892]

Can someone give this man a xanax pls

Lmao. Hes more of a scientist CEO than a straight business CEO. Its a different world in terms of public speaking and confidence.

 

[PetitGarsTimide]

Lmao. Hes more of a scientist CEO than a straight business CEO. Its a different world in terms of public speaking and confidence.

Don't worry he could be sweating, searching for every of his words I'll still buy a tons of his pills ))

 

[Yusher]

From the video, starts at 2:40
Pill - Hidden Hearing Loss & Tinnitus

• a pill that in preclinical models seems to be very effective at treating tinnitus (not mentioned whether acute and/or chronic t)
• seems to regrow the nerve endings in the inner ear
• may be able to restore hearing
• has been through Phase 1
• ready for Phase 2

Where are they situated ? Can they be competitor of Frequency?)

 

[Jim51042]

Where are they situated ? Can they be competitor of Frequency?)

Oklahoma City. In theory this is a nerve regrowth treatment so it wouldn't compete rather it would supplement a Frequency treatment.

 

[Autumnly]

Where are they situated ? Can they be competitor of Frequency?)

Oklahoma City. In theory this is a nerve regrowth treatment so it wouldn't compete rather it would supplement a Frequency treatment.

Hough Ear Institute is actually working on both, restoring hearing by regrowing hair cells and regrowing the nerve endings which also seems to help with tinnitus.

1) Inner Ear Hair Cell Regeneration (injection)
"Hough Ear Institute has created silencing RNA (siRNA) technology that regenerates the inner ear hair cells destroyed by noise-induced hearing loss. We are using silencing RNA technology to change supporting inner ear hair cells into sensory hair cells essential to hearing. "

Sources:

• article
• paper

2) Regrowing nerve endings (Hidden Hearing Loss? pill?) & Tinnitus
"Along with this, we are also working on restoring the connection between the auditory nerve and the hair cells that are disconnected when the hair cells die. We have both culture dish and live animal data that shows we can regenerate these fine nerve connections and reconnect them to hair cells for hearing restoration. In a clinical setting, this holds the potential to restore hearing function or reverse tinnitus disorders among millions of people whom currently have no viable options for achieving normal hearing." - source

I'm guessing 2) is the pill he was talking about in the video, not sure if that's the Bomb Blast Pill or not.

I can't find any information about phase 1 of the pill that's been talked about in the video.

 

[swc5150]

Should we believe this approach? Why hasn't anyone spoken of this?

They've been talked about quite a bit within a few threads. They have the "blast pill", which looks ready for phase 2. This is awesome news!!

 

[Jim51042]

They have the "blast pill", which looks ready for phase 2.

Do you know their Phase 2 start date?

 

[parsky]

This is the company that is tied to Hough Ear Institute:

http://otologicpharmaceutics.com/

 

[grate_biff]

This is the company that is tied to Hough Ear Institute:

http://otologicpharmaceutics.com/

Seems like the one who has completed phase one is for acute HL.
The one for chronic HL has been funded for further preclinical trials.

"OPI's program NHPN-1010, an oral medication to treat acute hearing loss, has successfully completed a Phase I clinical trial. Initial research focuses on NHPN-1010 as a treatment for Noise Induced Hearing Loss. OPI's program OPI-001, an innovative treatment for acute and chronic hearing loss through the regeneration of sensory hair cells, has been awarded a Congressionally Directed Medical Research Programs grant from the Department of Defense to fund further preclinical research and development."

 

[rsmcfar]

Here is a newspaper article in laymen's language.

http://newsok.com/article/5592955/o...hair-cells-critical-to-reversing-hearing-loss

 

[Jim51042]

"What we've discovered unexpectedly is that it regrows some key nerve endings in the cochlea by itself," Kopke said. "This pill actually regrows the nerve endings and reforms the synapses. So you can potentially take a pill and have a lot of your hearing restored and reduce tinnitus. That was unexpected."

Referring to NHPN-1010. Regrowth is by definition not an acute treatment. Does anyone know any human health side effects of taking NHPN-1010 pill daily?

 

[Benoves]

How does a pill end up in the cochlea? Thought it was almost impossible

 

[Autumnly]

Regrowth is by definition not an acute treatment.

Not necessarily or? I mean, if the hair cells are dead, regrowing the nerve endings won't help, so it could be an acute treatment. It depends on how long the hair cells can survive.

It also says in the article that "Otologic Pharmaceutics successfully completed a Phase 1 clinical trial for NHPN-1010 to treat acute noise-induced hearing loss and tinnitus".

So while this pill sounds promising we don't know whether or not it would help people with chronic tinnitus, we don't know how big the therapeutic window is.

Does anyone know any human health side effects of taking NHPN-1010 pill daily?

I don't know about the NHPN-1010 pill but Affichem is also working on a medication called AF-243 that "is effective to regenerate the auditory nerve functionality and also to prevent noise induced hearing loss on animal models." link

According to their homepage: "AF243 showed in vitro and in vivo efficacy on robust models of hearing loss. Furthermore, it showed neither toxicity nor other secondary effects. Thus AF243 may represent a real breakthrough in the treatment of sensorineural hearing loss. "

Also not sure whether you would have to take this pill daily or e.g. only once.

 

[Yusher]

Not necessarily or? I mean, if the hair cells are dead, regrowing the nerve endings won't help, so it could be an acute treatment. It depends on how long the hair cells can survive.

It also says in the article that "Otologic Pharmaceutics successfully completed a Phase 1 clinical trial for NHPN-1010 to treat acute noise-induced hearing loss and tinnitus".

So while this pill sounds promising we don't know whether or not it would help people with chronic tinnitus, we don't know how big the therapeutic window is.



I don't know about the NHPN-1010 pill but Affichem is also working on a medication called AF-243 that "is effective to regenerate the auditory nerve functionality and also to prevent noise induced hearing loss on animal models." link

According to their homepage: "AF243 showed in vitro and in vivo efficacy on robust models of hearing loss. Furthermore, it showed neither toxicity nor other secondary effects. Thus AF243 may represent a real breakthrough in the treatment of sensorineural hearing loss. "

Also not sure whether you would have to take this pill daily or e.g. only once.

Not necessarily or? I mean, if the hair cells are dead, regrowing the nerve endings won't help, so it could be an acute treatment. It depends on how long the hair cells can survive.

It also says in the article that "Otologic Pharmaceutics successfully completed a Phase 1 clinical trial for NHPN-1010 to treat acute noise-induced hearing loss and tinnitus".

So while this pill sounds promising we don't know whether or not it would help people with chronic tinnitus, we don't know how big the therapeutic window is.



I don't know about the NHPN-1010 pill but Affichem is also working on a medication called AF-243 that "is effective to regenerate the auditory nerve functionality and also to prevent noise induced hearing loss on animal models." link

According to their homepage: "AF243 showed in vitro and in vivo efficacy on robust models of hearing loss. Furthermore, it showed neither toxicity nor other secondary effects. Thus AF243 may represent a real breakthrough in the treatment of sensorineural hearing loss. "

Also not sure whether you would have to take this pill daily or e.g. only once.

So besides you need to restore hair cells you also need a pill which connect nerve to them again?

With FDA I'm guessing 5-10 years or less?Can they register in another country to make it not so long like with FDA?

 

[GGG-DG]

Not necessarily or? I mean, if the hair cells are dead, regrowing the nerve endings won't help, so it could be an acute treatment. It depends on how long the hair cells can survive.

It also says in the article that "Otologic Pharmaceutics successfully completed a Phase 1 clinical trial for NHPN-1010 to treat acute noise-induced hearing loss and tinnitus".

So while this pill sounds promising we don't know whether or not it would help people with chronic tinnitus, we don't know how big the therapeutic window is.



I don't know about the NHPN-1010 pill but Affichem is also working on a medication called AF-243 that "is effective to regenerate the auditory nerve functionality and also to prevent noise induced hearing loss on animal models." link

According to their homepage: "AF243 showed in vitro and in vivo efficacy on robust models of hearing loss. Furthermore, it showed neither toxicity nor other secondary effects. Thus AF243 may represent a real breakthrough in the treatment of sensorineural hearing loss. "

Also not sure whether you would have to take this pill daily or e.g. only once.

It was intended to treat acute hearing loss but they were surprised that it also helped for non-acute cases. From the article:

What we've discovered unexpectedly is that it regrows some key nerve endings in the cochlea by itself," Kopke said. "This pill actually regrows the nerve endings and reforms the synapses. So you can potentially take a pill and have a lot of your hearing restored and reduce tinnitus. That was unexpected."

 

[Aaron123]

Some context is important here. From the comments and questions, you would think they had posted results of a large, successful Phase 2 study. This is essentially a press release where the local newspaper is talking up a local company. There's basically no new information. It seems to be motivated by the publication of the paper in Molecular Therapy which was posted earlier in this thread. Moreover there is already a short thread about Otologic https://www.tinnitustalk.com/thread...ing-loss-prevention-and-treatment-pill.23494/

All of the discussion about HNPN-1010 should probably be moved to that thread. The more recent work on siRNAs belongs here.

From the video, starts at 2:40
Pill - Hidden Hearing Loss & Tinnitus

• a pill that in preclinical models seems to be very effective at treating tinnitus (not mentioned whether acute and/or chronic t)
• seems to regrow the nerve endings in the inner ear
• may be able to restore hearing
• has been through Phase 1
• ready for Phase 2

The clinical trial for NHPN-1010 ended in 2015, and apparently they have been planning for/ready for a phase 2 trial since then (http://otologicpharmaceutics.com/20...-i-trial-to-treat-noise-induced-hearing-loss/)

For more background, here is a press release from when the trial began: https://www.prnewswire.com/news-rel...npn-1010-for-hearing-disorders-283176701.html Notable quote "we anticipate top-line data in Q1 of 2015. This puts OPI on track to initiate Phase 2 clinical trials in NIHL or CIHL in 2015." Also, here's the clinicaltrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02259595?term=Otologic+Pharmaceutics&rank=1

The phase 2 trial has obviously not started yet; nor has there been announcement. They haven't published the Phase 1 results (that I can find) or anything on tinnitus.

Is this really a real thing??? Don't wanna be a pessimist, but it looks too good to be true...

It is a real thing. As for whether it is too good to be true, they haven't started Phase II trials for over two years and haven't raised any money beyond the initial ~ 4 million that Otologic Pharmaceutics received in 2014.

There are still many things we don't know about this pill:

True. Like pretty much everything except that they haven't started Phase 2 for two years and apparently haven't raised money off the phase 1 results.

In this article (RNA Injection Restores Hearing in Guinea Pigs, Hough Ear Institute) it says

• "As damaged hair cells in general cannot repair themselves, he explains, they'll die relatively quickly. At that point, regeneration is the only option to recover hearing. He says that lengthening the time between the damage and the initiation of treatment to a month, which would give damaged hair cells time to die, would help distinguish between repair and regeneration."

This article is discussing a completely different paper with a completely different treatment.

Do we know the Pill's name? Do we know an estimated Phase 2 schedule? Has there been or do they expect a Phase 1 paper coming out? If so when?

In order, Yes: NHPN-1010 which is a combination of NAC and HPN-07, No, No paper or discussion of one.

Does anyone know any human health side effects of taking NHPN-1010 pill daily?

There's no long term safety data on a drug that hasn't been approved.

I can't find any information about phase 1 of the pill that's been talked about in the video.

Links are earlier in this post.

It was intended to treat acute hearing loss but they were surprised that it also helped for non-acute cases. From the article:

It was intended for acute injury. Assuming* it regrows something does not mean it works on chronic cases. Given the compound, it it meant to prevent damage - it is after all basically antioxidants - therefore it would be surprising for it to regrow nerve endings in addition to preventing damage. Regrowth can still happen immediately after an injury so that does not imply any effect for non-acute cases. If you read their work, treatment is applied within 1-4 hours depending on the paper.

*In fact, absent a paper showing regrowth, even that is up in the air. The comments in the TheScientist article by Stone, Richardson, and Chen are telling.

From my perspective, Hough Ear has been very good at press releases and less good at publishing and raising money. It looks like they did get some military money recently and the paper in Molecular Therapy is interesting, but they are still very light on evidence to actually back up the claims they make - particularly those about restoring "a lot" of hearing.

 

[Paulmanlike]

Some context is important here. From the comments and questions, you would think they had posted results of a large, successful Phase 2 study. This is essentially a press release where the local newspaper is talking up a local company. There's basically no new information. It seems to be motivated by the publication of the paper in Molecular Therapy which was posted earlier in this thread. Moreover there is already a short thread about Otologic https://www.tinnitustalk.com/thread...ing-loss-prevention-and-treatment-pill.23494/

All of the discussion about HNPN-1010 should probably be moved to that thread. The more recent work on siRNAs belongs here.



The clinical trial for NHPN-1010 ended in 2015, and apparently they have been planning for/ready for a phase 2 trial since then (http://otologicpharmaceutics.com/20...-i-trial-to-treat-noise-induced-hearing-loss/)

For more background, here is a press release from when the trial began: https://www.prnewswire.com/news-rel...npn-1010-for-hearing-disorders-283176701.html Notable quote "we anticipate top-line data in Q1 of 2015. This puts OPI on track to initiate Phase 2 clinical trials in NIHL or CIHL in 2015." Also, here's the clinicaltrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02259595?term=Otologic+Pharmaceutics&rank=1

The phase 2 trial has obviously not started yet; nor has there been announcement. They haven't published the Phase 1 results (that I can find) or anything on tinnitus.



It is a real thing. As for whether it is too good to be true, they haven't started Phase II trials for over two years and haven't raised any money beyond the initial ~ 4 million that Otologic Pharmaceutics received in 2014.


True. Like pretty much everything except that they haven't started Phase 2 for two years and apparently haven't raised money off the phase 1 results.



This article is discussing a completely different paper with a completely different treatment.



In order, Yes: NHPN-1010 which is a combination of NAC and HPN-07, No, No paper or discussion of one.



There's no long term safety data on a drug that hasn't been approved.



Links are earlier in this post.


It was intended for acute injury. Assuming* it regrows something does not mean it works on chronic cases. Given the compound, it it meant to prevent damage - it is after all basically antioxidants - therefore it would be surprising for it to regrow nerve endings in addition to preventing damage. Regrowth can still happen immediately after an injury so that does not imply any effect for non-acute cases. If you read their work, treatment is applied within 1-4 hours depending on the paper.

*In fact, absent a paper showing regrowth, even that is up in the air. The comments in the TheScientist article by Stone, Richardson, and Chen are telling.

From my perspective, Hough Ear has been very good at press releases and less good at publishing and raising money. It looks like they did get some military money recently and the paper in Molecular Therapy is interesting, but they are still very light on evidence to actually back up the claims they make - particularly those about restoring "a lot" of hearing.

Thanks for clearing this up Aaron.

Where do these videos and statements come from with things like "it's shown to be very good at reducing tinnitus" and as a keen reader on tinnitus research I wondered what this guy was talking about. Absolute piss take to be honest to be saying stuff like this.

 

[jer]

I am not too far away from there and could easily fly to Oklahoma City. Has there been any information about the phase 2 trials yeat? Are they looking for patients?

 

[Rubenslash]

I am not too far away from there and could easily fly to Oklahoma City. Has there been any information about the phase 2 trials yeat? Are they looking for patients?

I believe the post from Aaron above answers your question.

 

[ozgeA]

what about H. ?

 

[SugarMagnolia]

I often have trouble understanding these research threads, so I don't know if this is something I should feel optimistic about. I've had T for over two years with no improvement from a single acoustic trauma. The idea of popping one pill and poof ~ tinnitus gone ~ sounds like a fantasy.

Is this only for people shortly after an acoustic trauma? I don't want to be filled with hope that this could help me, only to be told later "Sorry, none for you."

 

[Aaron123]

I often have trouble understanding these research threads, so I don't know if this is something I should feel optimistic about. I've had T for over two years with no improvement from a single acoustic trauma. The idea of popping one pill and poof ~ tinnitus gone ~ sounds like a fantasy.

Is this only for people shortly after an acoustic trauma? I don't want to be filled with hope that this could help me, only to be told later "Sorry, none for you."

They did a Phase 1 trial three years ago and haven't started Phase 2 so I don't think there's any reason to be particularly optimistic at the moment. Who knows if that will change in the future.

In the pre-clinical papers that are available, treatment starts within 1 - 4 hours. The drug is basically antioxidants and is meant to prevent cell death. Remember, the origins of this come out of blast research done for the military where it would be possible to administer it close to immediately.

 

[Rajin]

Everything I see so far is phase 1 trial , 1 1/2 , 1 3/4 , starting phase 2 . Is there any company at the last phase 3 ?

 

[SugarMagnolia]

Remember, the origins of this come out of blast research done for the military where it would be possible to administer it close to immediately.

That's the impression I was getting. I would need a time machine + a blast pill. Maybe in the future everyone will have a blast pill in their first aid kit, but this will not help us.

 

[Rubenslash]

I often have trouble understanding these research threads, so I don't know if this is something I should feel optimistic about. I've had T for over two years with no improvement from a single acoustic trauma. The idea of popping one pill and poof ~ tinnitus gone ~ sounds like a fantasy.

Is this only for people shortly after an acoustic trauma? I don't want to be filled with hope that this could help me, only to be told later "Sorry, none for you."

This thread is about hair cell regeneration. This will not make your tinnitus disappear as they will not be able to regrow all lost hair cells. And even if they could, we won't be sure that the tinnitus would suddenly disappear. What we can reasonably expect though is an improvement in the tinnitus if the hearing improves. Most people that wear hearing aids also notice a reduction in the tinnitus.

 

[SugarMagnolia]

This thread is about hair cell regeneration. This will not make your tinnitus disappear as they will not be able to regrow all lost hair cells. And even if they could, we won't be sure that the tinnitus would suddenly disappear. What we can reasonably expect though is an improvement in the tinnitus if the hearing improves. Most people that wear hearing aids also notice a reduction in the tinnitus.

I was thinking that T was caused by the death of hair cells, so if new hair cells could be grown, T would stop.

So this wouldn't benefit people who don't have hearing loss? Or maybe everyone with T has hearing loss even if they don't notice it.

A reduction in T would be better than nothing.