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Otonomy OTO-413 — Treatment of Hidden Hearing Loss

Why would there be a drug for hearing loss and another for hidden hearing loss?

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.
 
@JohnAdams What does Curcumin exactly do for keeping your neurons alive? Is there any scientific papers regarding this?

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."
 
I just looked at the photos of good and damaged hair cells on the CDC website.
http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-newsArticle_Print&ID=2325672

OTO-413 is a sustained exposure formulation of BDNF that has been advanced into IND-enabling activities for the treatment of hidden hearing loss.

OTO-413 is a proprietary 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 testing 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 hidden hearing loss, a synaptopathy-related hearing loss characterized by speech-in-noise hearing difficulty. This condition affects nearly 3% of the U.S. population.


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
 
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
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?
 
Lol do you know anything about stocks? First of all, your comparison with Auris does not make any sense. Secondly, all depends on their ability to get one of the products on the market. If yes, this could easily be a tenbagger or more, if no then you are obviously right.

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.
 
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.
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,..
 
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,..

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....
 
hidden hearing loss program could be interesting as I am not aware of any other biotechs currently planning to enter phase 1 in 2019
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.
 
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.
 
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.

Would be interesting to see the actual material that was presented
 
I wonder if this may also help with tinnitus....
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!
 
Is this for acute(short window of time) hearing loss or chronic hearing loss?
 
Is this for acute(short window of time) hearing loss or chronic hearing loss?

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
 
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...
 
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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