Acousia Therapeutics

Samir

Manager
Author
Staff
Benefactor
Jan 3, 2017
1,138
Sweden
Tinnitus Since
12/2016
Cause of Tinnitus
Accoustic trauma
I want to start a new thread about this company! I know that not a lot is known about it, since it's a small private company. It seems to me that they are written off as insignificant too easily!

However, the founder of this company - Prof. Dr. Hubert Löwenheim - is a senior clinician and researcher with focus on otology and neurotology. He was the first to describe the involvement of cell cycle regulators, especially p27Kip1, in the proliferation and differentiation of hair cells and supporting cells in the cochlea.

In 1998, he founded a company called Otogene AG with the aim to identify an inhibitor of p27Kip1 as a regenerative drug. He also founded Otogene Inc. in Seattle as a subsidiary of Otogene AG. In 2002, Otogen AG ceased its operation, but the US company has continued its operation and is now known as Sound Pharmaceuticals Inc.

Acousia is involved in the EU funded Regain project (ID 634893, EU contribution 5834340 EUR), as well as the Otostem project (ID 603029, EU contribution 5999784 EUR).

Professor Löwenheim is assigned to be the coordinator of the Otostem project. There have been several EU funded projects aimed at hearing restoration over the years, but this might be the biggest one so far. It's international too, because we have the US involved. We find several familiar names here, like Albert Edge from Massachusetts Eye and Ear, one of the founders of Decibel Therapeutics. We also find Stanford university on board, where we know professor Stefan Heller and his team is working on bringing back hearing for millions of people under the so called SICHL initiative.

Other names I want to mention only briefly is professor Helge Rask Andersen from Uppsala university (the only place in Sweden where you will find regenerative research efforts concerning the inner ear), and Rolf Jan Rutten who is the founder of Audion Therapeutics.

Professor Hubert Löwenheim is in it too deep to be neglected as insignificant. After all, he has been selected to lead this project, with all these big names in the field. So with this thread, I want to give the man some credit and recognition for his 20 years of dedicated work in inner ear regeneration. His company may be small and private at the moment, as most startup companies are. But I hope we will hear from this company very soon.
 
Thanks for sharing Michael!

So to sum up what it says in the Action On Hearing Loss article.
  • Small molecule drug
  • Gamma secretase inhibitor (GSI)
  • Middle ear injection
  • Successful in (mammalian) animal models
  • Phase I trial starts at Royal National Ear Nose and Throat Hospital in London during the second half of 2017.
  • Phase II trial will start at the end of 2017 and will run in the UK (UCL Ear Institute), Germany and Greece.
 
Apparently I have been living under a rock. With all the time I spend online reading about hearing loss(research) I don't know how I missed the REGAIN PROJECT. Brightens your day when you see news like this.
 
do you think you must have a German citizenship to participate ?
Where do I apply for citizenship? ;)

I don't know about that. So let's wait and see. But I would expect all citizens of participating countries to be allowed to take part.
 
At the bottom of the blog it says another blog coming out end of month from researchers/clinicians running REGAIN trial which will provide more info regarding how you can take part.
 
If Frequency and Regain both are preforming clinic trials in 2018 that would make 2 concurrent hearing regeneration human trials. How many human hearing regeneration trials have ever taken place? Genvec would count as 1. Has their been any others? Does seem like a changing tide in terms of treatments. My one grip would be that synaptic focused companies don't have the urgency or effort that hair cell companies do.
 
That's reallyyyyyyy coooooool.

I mean, it seems like now we know that regrowing hair cells is the BEST way to cure tinnitus.

I remember about Auris failure, but it was an old process based on old papers.

Now it's litteraly booming, like all companies are working as fast as they can to be the first on the market.

I bet that by the end of 2017 with EU trial, if it works the others companies like FX and Genvec will accelerate their work.
 
How do we know that ?
Obviously this is awesome news , but we have no proof at all that this will cure tinnitus.
right. It's pretty well documented that over a long period of time, chronic tinnitus causes gray matter density changes in the brain. In some cases this is actually tissue growth, but the thing most associated with tinnitus distress afaik is gray matter loss in the right anterior insula.

So, there's a question of to what degree the brain will repair itself, if hair cell loss is truly reversible. Only one way to find out....
 
From the blog post it looks like the treatment will turn supporting cells into new hair cells, so if new supporting cells don't grow after the treatment it might compromise the treatment of Frequency Tx which needs supporting cells.
 
If you follow Audion, this isn't exactly news. The problem is that this approach directly differentiates existing SCs into HCs so it results in a loss of SCs.
 
If you follow Audion, this isn't exactly news. The problem is that this approach directly differentiates existing SCs into HCs so it results in a loss of SCs.

So why didn't we hear about REGAIN/ACOUSIA before today ?

It has a high chance to cure tinnitus induced by noise and we'll have phase 1 result before 2017 (and maybe phase 2) !

I still don't get why we are overtalking about FX, Genvec... But this project did start around 2015 and phase 2 before 2018 !
 
So why didn't we heard about REGAIN before today ?
I had heard of it before today.
It has a high chance to cure tinnitus induced by noise and we'll have phase 1 result before 2017 (and maybe phase 2) !
We certainly don't know the possibility of success (for either hearing loss) before a Phase 1 trial. (For FDA trials, the probability of moving from Phase 1 to 2 is is a bit less than 2/3, and the probability of moving from phase 1 to approval is < 10%.) Moreover, the schedule of a phase 2 trial will depend on the results of the phase 1 trial and the regulatory agencies. The company does not set the actual schedule.
I still don't get why we are overtalking about FX, Genvec... But this project did start around 2015 and phase 2 before 2018 !
The project may have started in 2015, but the underlying results are from 2012 or 2013.
 
I had heard of it before today.

We certainly don't know the possibility of success (for either hearing loss) before a Phase 1 trial. (For FDA trials, the probability of moving from Phase 1 to 2 is is a bit less than 2/3, and the probability of moving from phase 1 to approval is < 10%.) Moreover, the schedule of a phase 2 trial will depend on the results of the phase 1 trial and the regulatory agencies. The company does not set the actual schedule.

The project may have started in 2015, but the underlying results are from 2012 or 2013.

It's only your purcentages dude, but I'm really hopeful since they prepare Phase II right after Phase I (means that it will succeed).

- If Phase I and II succeed the treatment will be on the market 1 or 2 years after.
- If it doesn't succeed like it was planned, others companies will learn about it and go faster.

It's all good man :beeranimation:
 
It's only your purcentages dude, but I'm really hopeful since they prepare Phase II right after Phase I (means that it will succeed).

- If Phase I and II succeed the treatment will be on the market 1 or 2 years after.
- If it doesn't succeed like it was planned, others companies will learn about it and go faster.

It's all good man :beeranimation:
After a phase II you have to run several phase III and some of them need quite a large number of applicants. So not one or two years after.

Either way we'll know about the efficency of this treatment quite soon (end of next year pronabl)
 
Oh my days! Am I reading this right? Trial in London!

I was wondering what has happened to the Regain project. This is great news to us deaf/ hard of hearing people.

I am scheduled for cochlear implant removal surgery in the next few weeks (right ear). My question is after implant removal would this therapy work? As it requires supporting cells to be turned into hearing cells. How would this work on an profound ear? I can always go for my left ear which has severe HL.

I would rather wait and apply for the phase 2 trial as phase 1 is merely concerned with safety issues regarding the therapy.

I live 90 mins away from London and I will definitely get in touch with the clinical team. Eagerly waiting for next months blog
 
I am scheduled for cochlear implant removal surgery in the next few weeks (right ear).
May I ask why you are removing it?

My question is after implant removal would this therapy work? As it requires supporting cells to be turned into hearing cells. How would this work on an profound ear?
No one really knows what the results will be of this trial.

The real question is if you have enough structural integrity left in that cochlea. This is where inner ear imaging technology could be useful, to help objectively answer this type of question. Unfortunately, we don't have the technology yet. Until we do, we have to rely on patient history and audiologic testing.

Did you get any improvement from the cochlear implant? How long have you had it?

I know there is something called insertion trauma. I am not entirely sure what type of damage to the inner structures of the cochlea these traumas cause. But this has been a heavily debated topic for many years. This trauma can vary in severity, depending on type of electrode used and how it's inserted. Insertion through the round window is considered less traumatic than cochleostomy where they make a hole in the bony part of the cochlea to insert the electrode. Then there is debate on what quadrant of the round window membrane is best to use as to avoid insertion trauma. So they have been trying for many years to find the best ways to insert the electrode, and design the electrode so that it causes least amount of trauma.

So the severity of any structural damage caused by the implant will depend on the type of electrode used and route of insertion.

Insertion causes trauma, and likelihood for a successful therapeutic treatment decreases. However, removal of the implant is likely to cause further trauma. So if you are seriously considering to participate in the trial, perhaps you should postpone the removal of the implant? Maybe you could keep the implant and receive the therapy? This is something you could discuss with your doctors and the trial organizers. I know it's a gamble and not an easy decision to make. But I think you should consider this alternative. Unless you really must remove the implant for some reason.
 
This project seems promising! As Razah said don't know if it will cure T for those who have some hearing loss , but we don't know if it won't as well 50/50 ...
 
You're right. Curing tinnitus by restoring hearing is only just a hypothesis. But it's the best shot we got so far. And a lot of bright minds support this hypothesis.

Screen Shot 2018-09-05 at 0.04.34.png


At the very least, if restoring hearing doesn't diminish tinnitus then tinnitus researchers can strike this off their list and focus on researching other methods for a cure.
 

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