Acousia Therapeutics

Discussion in 'Research News' started by Samir, Mar 17, 2017.

    1. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      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.
       
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    2. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      April 2011
      Cause of Tinnitus:
      syringing and now somatic T dental work
      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.
       
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    3. AUTHOR
      AUTHOR
      Samir
      Obedient

      Samir Manager Staff Benefactor Ambassador Advocate

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      Yes,
      Let's hope they go for this route.
       
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    4. Matt h

      Matt h Member

      Location:
      Chester/Nationwide
      Tinnitus Since:
      10/10/13
      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
       
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    5. Jim51042

      Jim51042 Member

      Tinnitus Since:
      3/28/16
      Cause of Tinnitus:
      Headphone use
      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.
       
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    6. Aaron123

      Aaron123 Member

      Tinnitus Since:
      00/0000
      Cause of Tinnitus:
      Irrelevant
      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.
       
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    7. Yahzib Rafiq

      Yahzib Rafiq Member

      Location:
      England, UK
      Tinnitus Since:
      01/1995
      Cause of Tinnitus:
      Sensorineural hearing loss due to premature birth
      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.
       
    8. AUTHOR
      AUTHOR
      Samir
      Obedient

      Samir Manager Staff Benefactor Ambassador Advocate

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      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:
       
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    9. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      April 2011
      Cause of Tinnitus:
      syringing and now somatic T dental work
      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.
       
    10. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      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?
       
    11. Matt h

      Matt h Member

      Location:
      Chester/Nationwide
      Tinnitus Since:
      10/10/13
      Thank you!
       
    12. Steven__

      Steven__ Member Benefactor

      Location:
      California
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Loud noise exposure, TMJ
      Has anyone heard of an update with project ?
       
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    13. Akk

      Akk Member Benefactor

      Location:
      Finland
      Tinnitus Since:
      2006
      Cause of Tinnitus:
      Unkonown
      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.
       
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    14. fade2black244
      Spaced

      fade2black244 Member Benefactor

      Tinnitus Since:
      03/2017
      Cause of Tinnitus:
      Noise Induced
      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...
       
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    15. Berik

      Berik Member Benefactor

      Tinnitus Since:
      11/2016
      Cause of Tinnitus:
      Unknown
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    16. Margus

      Margus Member

      Tinnitus Since:
      01/2015
      Cause of Tinnitus:
      Unknown
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    17. Berik

      Berik Member Benefactor

      Tinnitus Since:
      11/2016
      Cause of Tinnitus:
      Unknown
      10 mio is sufficient to keep the wheels spinning.
       
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    18. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
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    19. AUTHOR
      AUTHOR
      Samir
      Obedient

      Samir Manager Staff Benefactor Ambassador Advocate

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      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.
       
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    20. Bobb77
      Cynical

      Bobb77 Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Noise drama and stress
      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?
       
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    21. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
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    22. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      "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?
       
    23. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
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    24. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      Yeah me neither. Seems like a really short-sighted solution, if you can even call it that, because hearing loss will still occur naturally.
       
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    25. Bobb77
      Cynical

      Bobb77 Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      Noise drama and stress
      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.
       
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