Otonomy OTO-413 — Treatment of Hidden Hearing Loss

[Michael Larsen]

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.

 

[acufenero]

Cool thing! "Mid 2019" is actually pretty soon, though I wish it all could go even faster.

 

[Rubenslash]

Appears they are combining phase 1 + 2, does that mean they can directly start phase 3 afterwards without a separate phase 2 study?

 

[Kritish Gooriah]

It's possible that the competition find a treatment very fast, from which the package "phase 1+2" or it's for go fast that competition.

 

[Aaron123]

Appears they are combining phase 1 + 2, does that mean they can directly start phase 3 afterwards without a separate phase 2 study?

I believe so.

 

[acufenero]

I believe so.

By the way, what are your thoughts on this?

 

[VRZ78]

I don't get why they won't also try this on people with tinnitus and hyperacusis? In the research around this area there are some good belief that this could alleviate hyperacusis and tinnitus.

 

[NatureHiker]

I don't get why they won't also try this on people with tinnitus and hyperacusis? In the research around this area there are some good belief that this could alleviate hyperacusis and tinnitus.

Potentially treating hearing loss and running clinical trials to measure hearing are extremely easier than doing such for tinnitus and hyperacusis.

 

[Rubenslash]

I don't get why they won't also try this on people with tinnitus and hyperacusis? In the research around this area there are some good belief that this could alleviate hyperacusis and tinnitus.

Among the participants there will obviously be several tinnitus sufferers and I assume they will be measuring the tinnitus level as well.

 

[VRZ78]

Among the participants there will obviously be several tinnitus sufferers and I assume they will be measuring the tinnitus level as well.

True... I just hope they won't have trouble finding people for their trial, as identifying hidden hearing loss seems quite challenging...

 

[Contrast]

True... I just hope they won't have trouble finding people for their trial, as identifying hidden hearing loss seems quite challenging...

I think hidden hearing loss can be determined if one can still hear high frequency tones but they sound split and distorted. I imagine if it was more severe more tones across all frequencies would begin to sound split.

 

[VRZ78]

I think hidden hearing loss can be determined if one can still hear high frequency tones but they sound split and distorted. I imagine if it was more severe more tones across all frequencies would begin to sound split.

I doubt it but that's exactly what I have so fingers crossed...

 

[parsky]

I believe this a similar drug to what was used in this paper.

https://www.nature.com/articles/srep24907

 

[Contrast]

I believe this a similar drug to what was used in this paper.

https://www.nature.com/articles/srep24907

Good read

 

[jer]

If the neurons are needed to be electrically excitable to survive for us to be able to still have later on, is there something that can be done now to keep them alive? Any ideas people?

 

[Spiral]

If the neurons are needed to be electrically excitable to survive for us to be able to still have later on, is there something that can be done now to keep them alive? Any ideas people?

I can't remember where I read it but it mentioned that the neurons are still alive for decades after the hearing loss. It's just the synapse connecting the neurons to the haircells that die that this medicine will restore. So it gives me a little bit of hope to reduce the T.

 

[parsky]

If the neurons are needed to be electrically excitable to survive for us to be able to still have later on, is there something that can be done now to keep them alive? Any ideas people?

Don't Die. I've heard similar to what face2black said.

 

[Spiral]

Besides, isn't the neurons being over excited what causes the ringing sensation? Perhaps we only hear the T because the neurons are still alive while others who have hearing loss but not T aren't.

 

[Paulmanlike]

Besides, isn't the neurons being over excited what causes the ringing sensation? Perhaps we only hear the T because the neurons are still alive while others who have hearing loss but not T aren't.

Perhaps this is the case when people have t for years and years and it stop suddenly; the neurons eventually die.

 

[Spiral]

Perhaps this is the case when people have t for years and years and it stop suddenly; the neurons eventually die.

Yes. If only there were a test for this...

 

[swc5150]

Perhaps this is the case when people have t for years and years and it stop suddenly; the neurons eventually die.

That could be? My low pitched T, that started in the summer of 2014, suddenly went away a year ago. It was a brutal sound that lead me to this website. Whatever the case, it's been a blessing. I can deal with the high-pitched T I'm left with until a treatment comes out.

 

[Paulmanlike]

That could be? My low pitched T, that started in the summer of 2014, suddenly went away a year ago. It was a brutal sound that lead me to this website. Whatever the case, it's been a blessing. I can deal with the high-pitched T I'm left with until a treatment comes out.

That's interesting that it went away after 3 years; what caused it may I ask? I wish mine disappeared

 

[Rubenslash]

http://investors.otonomy.com/static-files/2b7ed6d7-7056-48e2-ad6c-f5aeace058e9

Was looking at the Otonomy presentation of August. Slide 19 clearly shows the efficacy of OTO-413 in an animal study as the synapse count in OTO-413 + noise is much higher than in the noise only situation.

Slide 21 is also interesting for OTO-6XX (hair cell regeneration).

From an investment point of view, Otonomy has a cash balance of $100m at the end of June while the market cap is currently $82m which means that for every $ you pay for Otonomy stock, you indirectly get 1,21$ in cash. Might be a really compelling long-term play, but very risky obviously as they will run out of cash somewhere in the future and will have to raise capital again to fund the research.

 

[JohnAdams]

http://investors.otonomy.com/static-files/2b7ed6d7-7056-48e2-ad6c-f5aeace058e9


Slide 21 is also interesting for OTO-6XX (hair cell regeneration).

They better hurry up. Some yellow idiot with an IQ of about 2 Billion is about to beat them to the chase.

 

[JohnAdams]

If the neurons are needed to be electrically excitable to survive for us to be able to still have later on, is there something that can be done now to keep them alive? Any ideas people?

CURCUMIN

 

[Paulmanlike]

Not the right time to invest in Otonomy. Look what happened to Auris Medical; well over 90% gone since the IPO.

 

[Silvio Sabo]

Not the right time to invest in Otonomy. Look what happened to Auris Medical; well over 90% gone since the IPO.

Otonomy has a completely different approach. Otonomy is not only in the tinnitus cure business either. They are also pursuing hearing loss with their OTO-4xx program. And they have more than one drug candidate in their pipeline. Also if everyone where to think that way we're never going to see a tinnitus cure.

 

[Rubenslash]

Not the right time to invest in Otonomy. Look what happened to Auris Medical; well over 90% gone since the IPO.

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.

 

[Contrast]

Otonomy has a completely different approach. Otonomy is not only in the tinnitus cure business either. They are also pursuing hearing loss with their OTO-4xx program. And they have more than one drug candidate in their pipeline. Also if everyone where to think that way we're never going to see a tinnitus cure.

Curing hearing loss should cure tinnitus if the tinnitus was caused by hearing loss.

 

[JohnAdams]

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