Hough Ear Institute's Hair Cell Regeneration Project

[Brian Newman]

@IntotheBlue03, you hear back from Dr. Kesari yet? And I read your tinnitus is much better now?

 

[dbeats]

Huge news.

Autigen Announces Collaboration with Boehringer Ingelheim to Discover and Develop Novel Treatments for Hearing Loss

 

[reggie green]

That says enough right there.

"Under the terms of the agreement, Autigen will receive an undisclosed upfront payment and research funding support. The company is also eligible to receive future success-based milestone payments of a total potential value of more than $100M if all milestones are achieved over the course of the partnership."​

 

[InNeedOfHelp]

Huge news.

Autigen Announces Collaboration with Boehringer Ingelheim to Discover and Develop Novel Treatments for Hearing Loss

That's massive! I just hope Susan Shore also has an investor from the big pharma behind it.

Having Boehringer Ingelheim behind this will bring funds and a lot more drive behind this to become first to market for hearing loss. The potential in revenue is big and they know it.

 

[DimLeb]

That's massive! I just hope Susan Shore also has an investor from the big pharma behind it.

Having Boehringer Ingelheim behind this will bring funds and a lot more drive behind this to become first to market for hearing loss. The potential in revenue is big and they know it.

I don't really understand how this is big news. Maybe I read it wrong, but are they just starting out to find therapies for hearing loss? I get that it's a big company and all, but it just means that we MAYBE have a treatment in about 10-20 years, right?

 

[AfroSnowman]

I don't really understand how this is big news. Maybe I read it wrong, but are they just starting out to find therapies for hearing loss? I get that it's a big company and all, but it just means that we MAYBE have a treatment in about 10-20 years, right?

Research into Hough Ear Institute's hearing loss pill has been basically stopped due to a lack of funding. I know for a long time they were pitching the tinnitus community for donations so that clinical trials could go forward. So getting real funding gets this drug back onto the path of clinical trials and we will be able to see how effective it is.

 

[dbeats]

I don't really understand how this is big news. Maybe I read it wrong, but are they just starting out to find therapies for hearing loss? I get that it's a big company and all, but it just means that we MAYBE have a treatment in about 10-20 years, right?

Hough Ear Institute has been working on this for many years. The publications "Regeneration of mammalian cochlear and vestibular hair cells through Hes1/Hes5 modulation with siRNA" and "Regeneration of cochlear hair cells and hearing recovery through Hes1 modulation with siRNA nanoparticles" was published back in 2013 and 2018.

 

[dbeats]

From Boehringer OKs $100M biobucks deal for hearing loss R&D project:

Progress has taken longer than originally planned. Otologic talked about getting into the clinic in 2017 when it licensed the technology from Hough and targeted a 2020 start of human studies when it landed the grant funding. With Boehringer on board, Otologic, through its Autigen subsidiary, now has support for its push to get into the clinic.​

Sounds to me like human trials could come relatively soon.

 

[Nobody19]

Huge news.

Autigen Announces Collaboration with Boehringer Ingelheim to Discover and Develop Novel Treatments for Hearing Loss

Finally, a big pharma player partnering up with Hough Ear Institute... Maybe this isn't a scam after all? I'm still wary though.

 

[dbeats]

Finally, a big pharma player partnering up with Hough Ear Institute... Maybe this isn't a scam after all? I'm still wary though.

After a joint research collaboration phase, Boehringer Ingelheim will be responsible for further preclinical and clinical development, and commercialization.

 

[scotty03874]

After a joint research collaboration phase, Boehringer Ingelheim will be responsible for further preclinical and clinical development, and commercialization.

This is positive news whichever way you read or interpret it. Hoping someone on this forum gets approved for compassionate use. I'll be next in line.

 

[scotty03874]

Damn Scotty, sorry to hear. Well, since most doctors don't know about this drug I think Dr. Kesari is our best bet on getting it. He is very understanding and he said he is waiting for Oblato with the final details, then will start getting the drug. He's figuring out if he can get the pills or IV and if he can get the IV shipped to our local doctor.

He's going to let me know in a month or so. I will be posting here when I hear back.

And yeah, the process is a ton of work for the doctor and that's why when everybody on this forum was most likely blowing him up I was getting upset because I know he doesn't want to fill out a crap ton of compassionate use paperwork when he's got patients with brain tumors to work on. I didn't want to overload him and cause him to not want to deal with us altogether. Hopefully this does not happen.

I believe to fix my catastrophic pain hyperacusis I definitely need synapse regeneration. My tinnitus is pretty shit too. If your main ENT is Dr. Foster in Miami, and if this drug starts rolling out for compassionate use, maybe he will be on board. Because if it's an IV you have to get it at the doctor anyways. Dr. Foster did know about regenerative medicine for the ear, so if I do get the IV, I will probably have it done there or at Silverstein.

Brian,

Has there been any progress on finding out if Dr. Kesari will be able to handle the compassionate use?

Secondly, why did you get a recent blood patch from Dr. Foster? For what reason? I may go down to South Beach this month and seek out a couple more blood patches from him. I spoke to him on the phone last week. I had a recent trauma on my left ear and I suspect I have a PLF. I flew recently and felt fluid in my right ear.

 

[Brian Newman]

Brian,

Has there been any progress on finding out if Dr. Kesari will be able to handle the compassionate use?

Secondly, why did you get a recent blood patch from Dr. Foster? For what reason? I may go down to South Beach this month and seek out a couple more blood patches from him. I spoke to him on the phone last week. I had a recent trauma on my left ear and I suspect I have a PLF. I flew recently and felt fluid in my right ear.

My appointment was in early March. I emailed him last month and he said they were still working on it. Gonna probably contact them again in a few weeks. I'm guessing it's Oblato's fault. They take forever. Hopefully I hear back soon.

And I thought I had a perilymph fistula, I just didn't have hearing loss and vertigo. I am dizzy and have all the other symptoms in that ear, got it from a heavy deadlift. I felt a little better from the patch but it went away after a week or so. I wanted to try it because it beats getting surgery or doing any of the vestibular testing.

Idk, I think I might have a CSF leak, probably won't figure it out for a while. Trying to get my noxacusis under control so I can start seeing doctors again. I probably should have kept seeing Dr. Foster for more blood patches but the drive is too far.

 

[Gb3]

@Brian Newman, any word on your compassionate use request?

 

[Brian Newman]

@Brian Newman, any word on your compassionate use request?

Nope, still waiting unfortunately.

 

[OptimusPrimed]

What is Hough Ear Institute doing these days? Whatever became of their bomb blast pill?

 

[ThomasF]

I found this. Not sure it will be of any help to anyone. It talks about NHPN-1010, the Bomb Blast Pill developed by Hough Ear Institute. The article has info regarding Oblato and the Compassionate Use program. Just looking up NHPN-1010 under news gets very little result. Hope this helps.

https://otologicpharma.com/the-science/

 

[SmallRonnie]

Nope, still waiting unfortunately.

I'm considering applying for the compassionate use myself.

Still no word?

NHPN-1010 has successfully completed single and multi-dose Phase I clinical trials as a treatment for acute NIHL. A Phase II clinical trial for NHPN-1010 is in development for later this year.

OPI-001 technology is capable of restoring hair cell numbers in noise-damaged rodents and has been shown to restore hearing function in mature noise-deafened guinea pigs.

No Phase 1 for that one yet it seems.

Such a long way off from getting to market even if everything goes perfectly right.

 

[Brian Newman]

I'm considering applying for the compassionate use myself.

Still no word?

Still waiting unfortunately.

 

[SmallRonnie]

Still waiting unfortunately.

Damn. Did you fill out the online form or did you email someone directly? Maybe it would be worth emailing them directly if you haven't. I wouldn't be surprised if they had a very large amounts of applicants.

It's hard to say if noxacusis or severe hearing loss is more debilitating. The noxacusis probably is more debilitating if it's severe. It's not something they are directly testing for though even if it makes sense that it would help.

 

[Brian Newman]

Damn. Did you fill out the online form or did you email someone directly? Maybe it would be worth emailing them directly if you haven't. I wouldn't be surprised if they had a very large amounts of applicants.

It's hard to say if noxacusis or severe hearing loss is more debilitating. The noxacusis probably is more debilitating if it's severe. It's not something they are directly testing for though even if it makes sense that it would help.

I've been in contact with them directly. Everything for hearing stuff takes light years. I don't want to offend anybody on these forums, being deaf is an absolute breeze compared to the hell I'm going through. I'm going to be trapped in my house in severe pain forever. Hopefully I find something soon. I posted a few days ago when I was in low pain, I need to stop posting when I'm in less pain, I jinx it every time lol.

 

[SmallRonnie]

I've been in contact with them directly.

Well I'm hoping they get back to you. In my opinion, you should be very high up the priority list for compassionate use if not the very top. My case is very similar to yours except my pain isn't as bad and gets better quicker, for now anyway. I have a good argument for compassionate use.

I posted a few days ago when I was in low pain, I need to stop posting when I'm in less pain, I jinx it every time lol.

I have done the same thing. Totally jinxed it lol. Trying to assess what things are giving me pain is a nightmare since I'm in pain in silence too, it's so hard to tell.

 

[Brian Newman]

Well I'm hoping they get back to you. In my opinion, you should be very high up the priority list for compassionate use if not the very top. My case is very similar to yours except my pain isn't as bad and gets better quicker, for now anyway. I have a good argument for compassionate use.

I have done the same thing. Totally jinxed it lol. Trying to assess what things are giving me pain is a nightmare since I'm in pain in silence too, it's so hard to tell.

Yeah I hope he has me at the top. He said he did, but who knows. I emailed Oblato too, they said they still haven't started it yet either.

Yeah my doing better is when my ears stop getting worse from every noise and my pain drops a little. The pain at this level though is ridiculous, I was throwing up all night. Horrible, awful night. My tolerance to beeps, squeals, metal noises, and artificial volume is like 0 even through double hearing protection. It's crazy. I have like pain attacks from it. Pretty crazy. When I'm feeling a little better I just try not to even think about it, post about it, nothing. Play my damn video games on mute 24/7 lol.

I hope this drug comes out soon for compassionate use.

Can't imagine getting permanent improvement.

 

[SmallRonnie]

Yeah I hope he has me at the top. He said he did, but who knows. I emailed Oblato too, they said they still haven't started it yet either.

Yeah my doing better is when my ears stop getting worse from every noise and my pain drops a little. The pain at this level though is ridiculous, I was throwing up all night. Horrible, awful night. My tolerance to beeps, squeals, metal noises, and artificial volume is like 0 even through double hearing protection. It's crazy. I have like pain attacks from it. Pretty crazy. When I'm feeling a little better I just try not to even think about it, post about it, nothing. Play my damn video games on mute 24/7 lol.

I hope this drug comes out soon for compassionate use.

Can't imagine getting permanent improvement.

I would imagine you will surely get compassionate use for this drug. Hopefully soon and hopefully permanent improvement. I think this or some other regen drug will eventually give permanent improvement.

It's hard to imagine how bad your case is. I thought I was bad with my pain but that's insanity what you're going through. I'm also playing video games on mute now which is quite annoying. I think I get pain after wearing earmuffs for too long. Pain from earplugs too. Pain from normal noises if not those lol.

If anyone deserves the compassionate use for this drug it's surely noxacusis patients. I really do think these regen drugs will work eventually which is the biggest thing that's keeping me going. And you will surely be getting compassionate use for all of them.

Did you ask for compassionate use for FX-322 too or is that even open?

 

[Brian Newman]

I would imagine you will surely get compassionate use for this drug. Hopefully soon and hopefully permanent improvement. I think this or some other regen drug will eventually give permanent improvement.

It's hard to imagine how bad your case is. I thought I was bad with my pain but that's insanity what you're going through. I'm also playing video games on mute now which is quite annoying. I think I get pain after wearing earmuffs for too long. Pain from earplugs too. Pain from normal noises if not those lol.

If anyone deserves the compassionate use for this drug it's surely noxacusis patients. I really do think these regen drugs will work eventually which is the biggest thing that's keeping me going. And you will surely be getting compassionate use for all of them.

Did you ask for compassionate use for FX-322 too or is that even open?

Yeah hopefully regen meds will be a thing this decade. I can't even imagine getting to a moderate level with this. I would be so happy. OTO-313 really crushed my spirit but people were iffy on it anyways.

FX-322 does not do compassionate use, neither does OTO-413. Let's hope they pass trials. At least Ebselen will come out but who knows what that will do for noxacusis.

I can definitely live at a bad level but this bad I need something to help. I hope these drugs aren't false hope, there's always hope for something for ear stuff, then it fails, been going on for decades. But there's more now than I have ever seen. I just hope I get it in time.

 

[ThomasF]

Yeah hopefully regen meds will be a thing this decade. I can't even imagine getting to a moderate level with this. I would be so happy. OTO-313 really crushed my spirit but people were iffy on it anyways.

FX-322 does not do compassionate use, neither does OTO-413. Let's hope they pass trials. At least Ebselen will come out but who knows what that will do for noxacusis.

I can definitely live at a bad level but this bad I need something to help. I hope these drugs aren't false hope, there's always hope for something for ear stuff, then it fails, been going on for decades. But there's more now than I have ever seen. I just hope I get it in time.

FX-322, FX-345, as well as OTO-413 are all injections through the tympanic membrane and the round window membrane. So those being compassionate use is probably never going to happen mostly due to it being a procedure and not a simple medication.

Ebselen being a pill as is NHPN-1010 is better suited because they are not invasive. As an aside, I've read up on inflammation and its connection to NIHL and tinnitus so I genuinely wonder if Ebselen can open up other treatments and improve their effectiveness.

 

[SmallRonnie]

I just saw on the Otologic website where they stated:

Our collaborators at Hough Ear Institute discovered our hearing loss pill (NHPN-1010) may treat tinnitus.

 

[Nick47]

Our pill technology regenerates the nerve ending between the cochlea and the auditory nerve. So, both in a sense.

It not only restores a meaningful connection with the nerves, but it also prevents them from being damaged in the first place. It was originally designed for the military. They are in a firefight for their lives, they can't stop and put on ear protection. However, the process the noise trauma causes begin after 24 hours and take several days to occur. The pill stops that process cold. We later discovered that it worked in a restorative function as well. Then we tested it with tinnitus. All with great data to support its efficacy.

Just reading from the beginnings of the thread. Was Justin De Moss here solely to raise funds?

What he mentions above when asked about acute versus chronic cases does not stack up with the literature published or at least what the drugs are trialled for.

 

[star-affinity]

Just got an email from Hough Ear Institute being invited to their "2022 Donor Awards Gala":

"Join us as we honor our exceptional donors and hear from incredible speakers including the first person to ever receive our tinnitus treatment, NHPN-1010!"​

I guess/hope that means good news (pretty please...)?

 

[Nobody19]

Just reading from the beginnings of the thread. Was Justin De Moss here solely to raise funds?

What he mentions above when asked about acute versus chronic cases does not stack up with the literature published or at least what the drugs are trialled for.

That's what I think too

Something is off when you claim to have such a great drug, yet struggle to find investors. Even when they did partner up with Oblato almost 3 years ago, they kept asking for donations. Has the Phase 2 trial even started yet?