Acousia Therapeutics

Super news!

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.

 

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.

 

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

 

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.

 

yes

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.

 

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.

 

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.

 

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?

 

Thank you!

 

Has anyone heard of an update with project ?

 

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.

 

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...

 

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

Again some funding towards hearing restoration..

 

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

 

10 mio is sufficient to keep the wheels spinning.

 

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-

 

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?

 

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?

 

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.

 

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

 

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.

 

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.

 

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.

 

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.