Otonomy OTO-413 — Treatment of Hidden Hearing Loss

Discussion in 'Research News' started by Michael Larsen, Jan 9, 2018.

    1. PlsHelpMe
      Dead

      PlsHelpMe Member

      Tinnitus Since:
      June 28th, 2018
      Cause of Tinnitus:
      A friend shot a cap gun into my ear. (Once)
      Just in case they failed on one of the drugs. Pray it doesn’t. Cure hearing loss equals cure tinnitus.
       
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    2. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      I wonder if curing HL/T will cure hyperacusis.
       
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    3. Silvio Sabo
      Pooptoast

      Silvio Sabo Member Benefactor

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      Because hearing loss is easier to measure. It probably will help tinnitus as well. But since you can actually quantifiably measure improvement of hearing loss with a simple hearing test it could be easier to have the drug approved and out on the market. And also there is a large portion of people who have hearing loss and no tinnitus.
       
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    4. jer

      jer Member

      Tinnitus Since:
      06/2015
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      Acoustic trauma
      @JohnAdams What does Curcumin exactly do for keeping your neurons alive? Is there any scientific papers regarding this?
       
    5. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      Here you are my love,


      NEUROPROTECTIVE EFFECTS OF CURCUMIN
      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2527619/

      "Curcumin has multiple desirable characteristics for a neuroprotective drug, including anti-inflammatory, antioxidant, and anti-protein-aggregate activities that we have previously reviewed.1,2 Because of its pluripotency, oral safety, long history of use, and inexpensive cost, curcumin has great potential for the prevention of multiple neurological conditions for which current therapeutics are less than optimal."
       
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    6. Contrast

      Contrast Member Benefactor Hall of Fame

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      I might as well try CURCUMIN
       
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    7. AmericanJosh

      AmericanJosh Member

      Location:
      Wisconsin, USA
      Tinnitus Since:
      8/2018
      Cause of Tinnitus:
      noise exposure while doing work on home
      I just looked at the photos of good and damaged hair cells on the CDC website.

      I just looked at the photo of damaged hair cells on the CDC website. The photos are likely from mouse models they use to do this research. In addition to the hair cells being destroyed, it looks like the bedding in which they are attached is also decimated. I wonder how they plan to repair this and if nee hair cells could possibly even grow in this area again, and if they dish would they be able to act as and be as strong as regular hair cells.

      https://www.cdc.gov/nceh/hearing_loss/how_does_loud_noise_cause_hearing_loss.html
       
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    8. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      It's really scary. The thing about the cochlea is that it's near impossible to tell what is happening inside, or why certain things happen. I'm not even so sure the bent haircells cant heal or even why they get like that by the time they are imaged with the electron microscope. The cochlea is enclosed in one of the hardest bony structures in the body. The have to saw into that to remove the organ and then coat the tissue with some kind of metal before they can put it under the electron microscope. How can we know that those hair cells cant heal so long as they are alive? What if they are like that from the extraction process and or the process to prepare them for imaging?
       
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    9. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
      2008
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      Noise
      Then why don’t you invest in Otonomy?

      Biotech stocks are incredibly risky, I’m not saying it’s a bad stock, but it is a highly speculative stock.

      Obviously suffering from Tinnitus, I hope they prevail. But even as a non-scientist common man, you don’t half see some assumptions here “curing hearing loss will cure tinnitus”. I have tinnitus and no measurable hearing loss on a normal audio gram. It’s a phenomenon and to this date, there is still no clue where it comes from. Betting on Otonomy at this stage to pour money into will be like playing Russian Roulette.
       
    10. Apolonia
      Disappointed

      Apolonia Member

      Location:
      Croatia
      Tinnitus Since:
      December 2017
      Cause of Tinnitus:
      Noise induced, acoustic trauma
      Curcumin makes my tinnitus worse... So? It did help with hyperacusis...
       
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    11. Rubenslash

      Rubenslash Member

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      I own several biotech companies but at this point Otonomy is indeed too speculative. If one of their hearing loss programs show efficiency in phase 2 I might start a position though. Especially the hidden hearing loss program could be interesting as I am not aware of any other biotechs currently planning to enter phase 1 in 2019 while for HC regeneration there is competition from several companies including Frequency, Audion,..
       
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    12. Paulmanlike

      Paulmanlike Member Hall of Fame

      Tinnitus Since:
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      Same with me, it’ll be great to invest in them and if they are successful, it’ll make a great investment. If you want to talk about stocks, feel free to inbox me so we don’t use up all the thread. Biotechs pay when they’re successful :)

      I did look into getting into Auris after phase 2, but as you can see what happened there....
       
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    13. Jim51042

      Jim51042 Member

      Tinnitus Since:
      3/28/16
      Cause of Tinnitus:
      Headphone use
      I've been emphasizing this for a year and a half. There is a lack of focus on the nerves within the ear and thus a market inefficiency towards that area of the ear. A solid nerve growth factor within the ear will end tinnitus for a substantial portion of people with T. If they can repair/regrow functional nerves with the ear every person on this site should consider application of this drug.
       
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    14. Tigo

      Tigo Member

      Tinnitus Since:
      2 years
      Cause of Tinnitus:
      genetic hearing loss
      http://investors.otonomy.com/news-r...ents-data-highlighting-potential-oto-413-otic

      Press Release

      Otonomy Presents Data Highlighting Potential of OTO-413, an Otic Sustained-Exposure Formulation of BDNF, to Treat Hearing Loss
      Society for Neuroscience Features OTO-413 Presentation as Neuroscience 2018 Hot Topic

      SAN DIEGO, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today is presenting data on the therapeutic potential of OTO-413, an otic sustained-exposure formulation of brain-derived neurotrophic factor (BDNF). These promising preclinical data, demonstrating the potential of intratympanic BDNF to repair cochlear synaptopathy, an underlying cause of hearing loss including speech-in-noise hearing difficulty, are being presented as part of the Society for Neuroscience(SfN) Annual Meeting in San Diego, November 3-7, 2018.

      “The selection of our OTO-413 presentation as a Neuroscience 2018 Hot Topic acknowledges the increasing interest in better understanding the neuroscience of the inner ear and the importance of Otonomy’s work to address the significant unmet needs of people living with hearing loss as well as other burdensome otologic conditions, such as Ménière’s disease, and tinnitus,” said Kathie Bishop, Ph.D., chief scientific officer of Otonomy. “These data, showing that OTO-413 improves measures of cochlear synaptopathy, support our ongoing activities to initiate a Phase 1/2 clinical trial in people with speech-in-noise hearing loss in 2019.”

      Recent scientific advances have shown that the loss of synaptic connections between inner ear hair cells and spiral ganglion neurons contributes to hearing impairment. This cochlear synaptopathy is proposed as an underlying pathology in age-related and noise-induced hearing loss and is also believed to contribute to the common difficulty of hearing speech in the presence of background noise. Overall, there are more than 50 million people in the U.S. with acquired hearing loss including a significant proportion experiencing speech-in-noise hearing difficulty. Results from these studies demonstrated that a single intratympanic administration of OTO-413 provided sustained-exposure of BDNF to the inner ear and that OTO-413 improved both the structural and functional deficits of cochlear synaptopathy in an animal model.

      “Hearing loss can have a profound impact on individuals’ daily lives and contributes to impaired social, psychological, and cognitive function. As the population ages and noise exposure in our society steadily increases, understanding and treating hearing loss is one of the most important efforts of our time,” said Barbara Shinn-Cunningham, Ph.D., Director, Carnegie Mellon Neuroscience Institute and Professor, Center for the Neural Basis of Cognition, Biomedical Engineering, Psychology, and Electrical & Computer Engineering at Carnegie Mellon University. “Over the last decade, extensive evidence from both preclinical and clinical studies has revealed that a loss or dysfunction of synaptic connections plays an important role in the pathophysiology of hearing loss. This kind of hearing loss, which can come about from aging and noise exposure, seems to manifest especially in difficulties understanding speech in noisy, social settings, which in turn leads to social isolation, depression and early cognitive decline. Recognition by the Society for Neuroscience of cochlear synaptopathy as a Hot Topic at this year's annual meeting signals the practical importance of hearing loss for everyday function and the exciting potential of treatment through synaptic repair.”

      About OTO-413

      OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotropic factor (BDNF) which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies by Otonomy and other research groups have demonstrated that local administration of BDNF repairs ribbon synapses damaged due to noise trauma or exposure to ototoxic chemicals and restores hearing function. Otonomy has initiated nonclinical studies and manufacturing for OTO-413 to support an Investigational New Drug (IND) Application, with a Phase 1/2 clinical trial expected to begin in hearing loss patients in the first half of 2019. The initial indication for OTO-413 will be patients with synaptopathy-related hearing loss that is characterized by speech-in-noise hearing difficulty.

      About Otonomy

      Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for otology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.
       
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    15. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

      Location:
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      Tinnitus Since:
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      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      I wonder if this may also help with tinnitus....
       
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    16. Johan_L

      Johan_L Member

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      Sweden
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      Would be interesting to see the actual material that was presented
       
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    17. grate_biff
      Alone

      grate_biff Member Benefactor

      Location:
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      Acoustic trauma, benzo/mirtazapine withdrawal, or combo!
      Probably, yes. As we know we are more prone to synaptopathy than loss of the HC itself.

      Question is, does a HC survive without its ribbon synapses?

      What will FX-322 do with corresponding progenitor cells of a healthy HC with retracted synapses?

      I´ll stop myself there. I do not know shit.

      I´m happy, though, that they are working in both fields.

      2019 could be a very interesting year, indeed!
       
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    18. Enclave

      Enclave Member

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    19. Contrast

      Contrast Member Benefactor Hall of Fame

      Location:
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      injury from noxious noise
      Is this for acute(short window of time) hearing loss or chronic hearing loss?
       
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    20. Johan_L

      Johan_L Member

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      Sweden
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      This slides indicates it is for chronic HL, as their target population is stated as the 9M with SiN HL. If it was just for acute they should have stated like "100 000 cases/year" or something similar as their target pop.

      upload_2018-11-10_19-23-39.png
       
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    21. Johan_L

      Johan_L Member

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    22. Jim51042

      Jim51042 Member

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      If anyone knows the reason for this date slippage please post to the community!!!
       
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    23. Rojo

      Rojo Member

      Tinnitus Since:
      October 2018
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      Neomycin/Xiflaxin
      I'm more interested in applying to be a part of this study... I have a great audiogram but horrific hyperacusis along with significant tinnitus, and definitely have the speech in noise and music distortion issues. This could be a total cure for me. I wrote in on their contact us page but if anyone has advice on how to get myself in one of these trials, I'm all ears...
       
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    24. GSC
      Wishful

      GSC Member Hall of Fame

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      These people are doing the Meniere's treatment a city over me. Ten minutes away. Does anyone know if the clinical trials also took place in the same location and if phase 2 has accepted applicants yet?
       
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    25. Enclave

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    26. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

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    27. Paulmanlike

      Paulmanlike Member Hall of Fame

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      @Hazel we need a Q&A with Otonomy! Their pipeline is too big not to get excited about.
       
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    28. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      I can state as a matter of fact that eardrum injections of BDNF are safe.
       
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    29. Paulmanlike

      Paulmanlike Member Hall of Fame

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      I'll never take anything you say seriously.
       
    30. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      It's going to require multiple doses.
       
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