Acousia Therapeutics

[Coleoptere]

Super news!

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)

I read that during Phase III the drug can already be marketed. So that is a possibility. See:

https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_III)

But let's first see what happens in Phase I and II. Exciting news anyway. I'm also curious when Audion Therapeutics will start their trials.

 

[Greg Sacramento]

I took a look at to how much space that they acquired for this trial (a few computer desks) and the rest is shared resources in association with LabCentral. They tried hard for first round financing and only received 2.81 million from 3 venture capital investors.

Most of these hair cell regeneration programs are set at Elbert Edge - Massachusetts Eye and Ear Infirmary - LabCentral Resources. It's sort of like companies renting office space that have resources and personal to assist your company. Granted, LabCentral is fully resourced with technology and lab services. Eli Lilly has given small amounts of venture capital as grants to these companies. If Lilly was more committed, the funding would be recorded as a corporate INC expense. Large drug companies often throw out a 100 million to some biotech without batting an eye. Although they will take a good percentage of any approvals as marketing rights. I'm not saying that like many publicly traded biotech companies that these particular private ones are a scam, but they should have bigger capital behind them. The ones that run these companies will receive a paycheck.

 

[Samir]

I read that during Phase III the drug can already be marketed. So that is a possibility.

Yes,

Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, pre-clinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.

Let's hope they go for this route.

 

[Matt h]

After being one of the first to complete the Am 101 trial in Uk in im intersted in this REGAIN TRIAL but was wondering if again its an injection or in tablet form any suggestions? Or am i missing something sounds very promising though

 

[Jim51042]

This phase I trial, which focuses on the safety of the treatment in people, is scheduled to commence at the Royal National Ear Nose and Throat Hospital in London during the second half of 2017 (pending regulatory approval); the phase II trial will start at the end of 2017 and will run in the UK, Germany and Greece.

Is this the typically length between start of a phase 1 trial and start of phase 2 trial less than 6 months? Do phasing lengths vary widely or is there standard general schedule that companies try to adhere to? What would cause this variation? Obviously this would be under the assumption that a the trial goes well.

 

[Aaron123]

Do phasing lengths vary widely

yes

What would cause this variation?

The condition being treated. Knowing whether a hearing loss treatment works should be relatively quick compared to knowing whether an Alzheimer's drug works. The issues that may take some time with Audion/Frequency/Decibel are safety and durability.

It's also worth noting that companies don't set these timelines by themselves. Initial lengths of trials will be set by the companies in conjunction with the regulatory agencies. As in cases like CGF166, trial dates may be adjusted. Additionally, companies do not set the time between trials. In the case of the time between Phase 1 and Phase 2, that will depend on the safety data, how long it takes the regulatory agency to review the data, and on how long it takes to have approval for the phase 2 trial.

 

[Anonymous2929]

May I ask why you are removing it?

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.

Hi Samir, I was implanted in 2013 and I had worked hard for 2 years trying to adapt and benefit from the implant. It hasn't worked out. My brain for some reason cannot adjust to the mechanical sounds. This may be due to the fact I was born hard of hearing but have always heard "natural" sounds. Not sure if you understand what I mean. The past year, I have been using my hearing aid in my non-implanted ear.

No improvement from the implant. I found it further enhances lip reading. This is what I am doing with my hearing aid! If I had any idea that an implant only helps aid lip reading, no way I would have gone ahead. It is far too loud, it cannot difference between sounds and the background noise is too much to bear.

Well, I am implanted with Me-del implant and they suppose to have the softest electrode. Not sure what method in terms of surgery they used on me. I know I am missing temporal bone behind my ear.

I had an consent meeting with the implant centre. Not sure if you heard of my hospital. Its called Addenbrookes in Cambridge. Suppose to be top ten in world and the surgeons are world class. We spoke about the surgery and he said its quite simple to remove implant and takes around 60 minutes. I asked whether my cochlea is damaged due to the electrode and his answer was that it was damaged before surgery anyway. Not an straight forward answer to be honest. We discussed what shall we do about the electrode. And we decided to leave it in the cochlea. Not sure if it is wise to do so in terms of future treatments etc.

I will definitely contact the clinical team regarding this trial. Eagerly waiting for next months blog which may have contact details.

 

[Samir]

but was wondering if again its an injection or in tablet form

It is an intratympanic injection. So the procedure should be the same as with the Auris Medical trial. But I think it's only administered once. So I don't think you will have to receive several injections.

This is from the article text:

One example of such a treatment involves introducing a small molecule drug called a gamma secretase inhibitor (GSI) into the middle ear via an injection through the eardrum.

 

[Greg Sacramento]

The FDA division of Biologics Evaluation and Research would engage with these gene cell concept companies before and during clinical trails. Before any human testing they must have a biologics license.

 

[Coleoptere]

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.

Hi @Aaron123: I wonder: how many SC's does a human actually have or do we have more than enough of them? And will, as far as you can assess it, these new HC's attrack neurons as the HC's in the FT approach?

 

[Matt h]

It is an intratympanic injection. So the procedure should be the same as with the Auris Medical trial. But I think it's only administered once. So I don't think you will have to receive several injections.

This is from the article text:

Thank you!

 

[Steven__]

Has anyone heard of an update with project ?

 

[Akk]

As for me hearing loss (left ear, above 4 khz) seems to be reason to my tinnitus. I have had hearing aid now about month, and I would rate that T has decreased 30-50 % when wearing HA. I got also tinnitus masking sound program (I picked pink noise) which I havent tested yet enough, but it seems promising.

 

[Spiral]

Do you mean our current guess is that this is the best way to cure T ?
There is no proof of that , not that I am aware of.

Regardless if it does or doesn't, I'd love to have my higher frequency hearing back. So if it cures the T, great. If not the hearing benefit will be well worth it.

Hearing regeneration is still related as most tinnitus happens because some sort of hearing loss...

 

[Berik]

http://www.acousia.com/wp-content/u...ay2018-FINAL-APPROVED-BY-CLIENT-EDITED-BP.pdf

Again some funding towards hearing restoration..

 

[Margus]

10mio doesn't sound much, I wonder if that means hearing regeneration is not considered promising among investors because possible returns are in very distant future.

I bet all startups together working on hearing regeneration had attracted less investments then jokes like this:
https://www.theguardian.com/technology/2017/sep/01/juicero-silicon-valley-shutting-down

 

[Berik]

10mio doesn't sound much, I wonder if that means hearing regeneration is not considered promising among investors because possible returns are in very distant future.

10 mio is sufficient to keep the wheels spinning.

 

[lapidus]

Some news from german company Acousia (from may 14). Not exactly related to the topic of regeneration since this is about prevention but maybe another company in the game to keep an eye on I guess?
https://www.businesswire.com/news/home/20180514005458/en/Acousia-Therapeutics-Announces-

 

[Samir]

Not exactly related to the topic of regeneration since this is about prevention but maybe another company in the game to keep an eye on I guess?

Yes, I think Acousia is worth keeping an eye on. But they are not only about protection and prevention. They also focus on regeneration.

From the press release:
"The company has established a portfolio of innovative cures for sensory hair cell protection and functional restoration with its its lead drug candidate ACOU085 being developed for clinical application in cisplatin-related otoprotection."

Also on their website they write:
"Since there is no causal medical treatment for sensorineural hearing loss today, the goal of ACOUSIA is to establish drug development of small molecule compounds that trigger regeneration of sensory hair cells and allow for causal treatment of sensorineural hearing loss in patients who already lost their hair cells years ago."

Their English may not be very good, but it's clear that their approach is two-fold: protection and regeneration.

 

[Toby1972]

Why are Acousia Therapeutics so silent? I read they wanted to start clinical trials in 2020. Their website is not up to date. They got $10 million in 2018 to organize clinic trials, but isn't that amount of money too little for running clinical trials?

 

[Tezcatlipoca]

Acousia Therapeutics news!

Hearing Loss Company Acousia Therapeutics Presenting at Upcoming Drug Development and B2B Conferences

 

[Diesel]

Acousia Therapeutics news!

Hearing Loss Company Acousia Therapeutics Presenting at Upcoming Drug Development and B2B Conferences

"Despite the overwhelming burden of hearing loss for patients and society, the quest for drug therapies against hearing loss remains one of the most under-resourced areas in drug discovery."​

I am glad to see more firms recognizing this. I am disappointed that it has to keep being said over and over again.

"Acousia Therapeutics GmbH is developing a series of small molecule drug candidates for local and systemic treatment of different forms of hearing loss."​

Small molecules, you say? I wonder what they're mixing together?

 

[FGG]

"Despite the overwhelming burden of hearing loss for patients and society, the quest for drug therapies against hearing loss remains one of the most under-resourced areas in drug discovery."​

I am glad to see more firms recognizing this. I am disappointed that it has to keep being said over and over again.

"Acousia Therapeutics GmbH is developing a series of small molecule drug candidates for local and systemic treatment of different forms of hearing loss."​

Small molecules, you say? I wonder what they're mixing together?

http://www.acousia.com/pipeline/otoregeneration/

In general, I'm not too excited about methods which involve reprogramming support cells to turn them into hair cells because it depletes support cells, which have a function in maintaining hair cell health. So, not only would your new hair cells be more prone to injury, you would lose the ability to restore them later.

But I am interested in their pre-clinical findings.

 

[Tezcatlipoca]

In general, I'm not too excited about methods which involve reprogramming support cells to turn them into hair cells because it depletes support cells, which have a function in maintaining hair cell health. So, not only would your new hair cells be more prone to injury, you would lose the ability to restore them later.

But I am interested in their pre-clinical findings.

Yeah me neither. Seems like a really short-sighted solution, if you can even call it that, because hearing loss will still occur naturally.

 

[Toby1972]

I almost don't care what they mix together.

I will apply for Phase 1, knowing that the total of:

• Getting in the study,
• Not receiving placebo and,
• Experiencing positive effects

is estimated at less than 0.01 percent.

That just gives me hope in my subconscious to be able to endure my miserable condition for another year without wanting to be buried.

 

[Nobody19]

Hearing loss company Acousia Therapeutics: first patient with age-related hearing loss treated with ACOU085

https://www.acousia.com/first-patient-with-age-related-hearing-loss-treated-with-acou085/

ACOU085, the lead candidate from Acousia Therapeutics, has been administered to the first patient with age-related hearing loss (presbycusis) in a Phase 1b clinical study in Germany. The pre-screening of patients matching the comprehensive in/exclusion criteria for the ongoing trial is almost complete. In addition to the principle objective of the study, testing the safety and tolerability of the drug candidate in humans for the first time, a wide array of subjective and objective hearing tests are being conducted to support the investigation of target engagement.

ACOU085 is a proprietary small-molecule, otoprotective drug candidate that modulates a well-defined molecular target preferentially expressed in the sensory cells of the inner ear, the so-called outer hair cells (OHC). ACOU085 is characterized by a unique dual mode of action: the molecule triggers the acute enhancement of hearing function and offers long-term preservation of the terminally differentiated OHCs. In December 2021, Acousia Therapeutics was granted a CTA by the German BfArM to initiate its first-in-human Phase 1b clinical trial of ACOU085.

"This next step of Acousia's otoprotective drug candidate ACOU085 into studies on patients suffering from presbycusis marks an important milestone on our path towards making hearing loss a treatable disease," says Dr. Tim Boelke, Chief Executive Officer and Chief Medical Officer of the company.

"I am extremely proud that our hypothesis-driven, scientific work is now moving into the clinical stage only 6 years after initiating a full-fledged de novo drug development program on a novel, highly innovative drug target," adds Hubert Löwenheim, Professor and Chair of the Department of Otolaryngology-Head & Neck Surgery of the University of Tübingen and Acousia Therapeutics co-founder.

 

[DimLeb]

Hearing loss company Acousia Therapeutics: first patient with age-related hearing loss treated with ACOU085

https://www.acousia.com/first-patient-with-age-related-hearing-loss-treated-with-acou085/

ACOU085, the lead candidate from Acousia Therapeutics, has been administered to the first patient with age-related hearing loss (presbycusis) in a Phase 1b clinical study in Germany. The pre-screening of patients matching the comprehensive in/exclusion criteria for the ongoing trial is almost complete. In addition to the principle objective of the study, testing the safety and tolerability of the drug candidate in humans for the first time, a wide array of subjective and objective hearing tests are being conducted to support the investigation of target engagement.

ACOU085 is a proprietary small-molecule, otoprotective drug candidate that modulates a well-defined molecular target preferentially expressed in the sensory cells of the inner ear, the so-called outer hair cells (OHC). ACOU085 is characterized by a unique dual mode of action: the molecule triggers the acute enhancement of hearing function and offers long-term preservation of the terminally differentiated OHCs. In December 2021, Acousia Therapeutics was granted a CTA by the German BfArM to initiate its first-in-human Phase 1b clinical trial of ACOU085.

"This next step of Acousia's otoprotective drug candidate ACOU085 into studies on patients suffering from presbycusis marks an important milestone on our path towards making hearing loss a treatable disease," says Dr. Tim Boelke, Chief Executive Officer and Chief Medical Officer of the company.

"I am extremely proud that our hypothesis-driven, scientific work is now moving into the clinical stage only 6 years after initiating a full-fledged de novo drug development program on a novel, highly innovative drug target," adds Hubert Löwenheim, Professor and Chair of the Department of Otolaryngology-Head & Neck Surgery of the University of Tübingen and Acousia Therapeutics co-founder.

That's great news! Now, if only these baby steps by all these hearing companies were taken a decade ago, hearing loss and tinnitus would certainly be treatable by now.

 

[ploughna]

I like that they're talking about hearing restoration with no mention of speech clarity (yet!). It'll be interesting to see how well their delivery mechanism penetrates the cochlea and what kind of results they see even at this Phase 1 stage.

 

[Toby1972]

I intended to take part in the study.

I phoned one of the company owners, described my situation, severe hearing loss on the left, slight hearing loss on the right, massive tinnitus on both sides, I'm in my early 40s.

However, they only offer one study for age-related hearing loss, so I cannot participate.

 

[Geatly]

I intended to take part in the study.

I phoned one of the company owners, described my situation, severe hearing loss on the left, slight hearing loss on the right, massive tinnitus on both sides, I'm in my early 40s.

However, they only offer one study for age-related hearing loss, so I cannot participate.

Wtf, age-related hearing loss is same as noise trauma/noise exposure hearing loss.

Age-related hearing loss just took a little bit longer and wasn't triggered within a few days/hours, but was progressing slowly over years also from noise, just not that drastically.