Otonomy OTO-313 — Treatment of Tinnitus

Otonomy to present at the ARO with regards to OTO-313.

"In particular, we are pleased to present information on our clinical program for OTO-313, including the Phase 1/2 clinical trial in tinnitus patients to be initiated next quarter, and preclinical data related to our OTO-510 program for otoprot.....”

http://investors.otonomy.com/news-r...s-multiple-presentations-association-research

I guess the million dollar question is whether OTO-313 is for acute or for chronic tinnitus as previously talked about, it’s based on a similar MOA to AM-101 that failed. AM-101 was for chronic tinnitus.

Anyway, I will try and get in touch with Otonomy and see if I can obtain any information after they’ve presented that may shed some light on this.

 

AM 101 was intended for the acute phase of tinnitus (first 3 months), later they extended the trial for up to a year and both fail to give any positive result.

Similar way of acting in the same receptor (NMDA) but with a stronger (more affinity or more potent) product than AM 101 as i understand

AM 101 did not do anything for the single acoustic trauma that cause my tinnitus started the trial at the 3 month mark (placebo vs AM 101 dont know) and did a second round with AM 101 at the 6 month mark

 

Found this before:

http://mundotinnitus.com/en/nst-001-tinnitus-cure/

Allegedly, this drug NST-001 had passed 2 clinical trials and the company disappeared.

Here it is claimed this drug NST-001 is OTO-311 and now OTO-313.

Otonomy has allegedly bought this off this company called NeuroSystec.

 

https://www.prnewswire.com/news-rel...nt-rights-for-tinnitus-program-230024181.html

It’s true where they say that Otonomy did buy NeuroSystec and the intellectual rights, I’m just curious of the 2 trials they did to show efficacy? And I am still under the assumption OTO-313 is only for acute tinnitus?

 

Otonomy did a presentation at ARO 2019 and one the leading presentations was that of OTO-313.

@David have you got any news what they presented at Baltimore?

 

Are you serious ? Are you sure it's for acute...? I also had the same impression

 

No I am not sure it’s for acute. In fact a conversation I had with @attheedgeofscience who has a financial background, a recent slide seemed to indicate they could be targeting acute and chronic.

Of course though, this is speculation.

I think he suggested it may have something to do with the target population.

We’ll just have to wait and see.

My hope is in Neuromod and bimodal neuromodulation at this point rather than an NMDA receptor antagonist.

Otonomy seem to think there is still hope in this MoA.

 

https://www.globenewswire.com/news-...-2-Clinical-Trial-of-OTO-313-in-Tinnitus.html

"We are excited to advance the clinical development of OTO-313 by initiating this trial, which will evaluate the therapeutic potential of OTO-313 in patients with tinnitus,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We expect results from this study in the first half of 2020 and will use the information to inform the design and plan for further clinical development.”

 

YAY.

 

From the above linked article: -- "OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine in development for the treatment of tinnitus. "

From the below-linked PubMed article: -- "Gacyclidine, a non-competitive NMDA receptor antagonist..."

Effects of extracochlear gacyclidine perfusion on tinnitus in humans: a case series.

 

What a week.

 

I'm planning on contacting the ENT quoted in the article Dr Susan King. I live in Houston so it wouldn't be that hard to drive to San Antonio.

"Tinnitus is a common problem affecting millions of people,” said Susan Marenda King, M.D., Neurotologist and Otologist at the Ear Medical Group in San Antonio, and Clinical Professor at the University of Texas Health Science Center. “The constant annoyance of tinnitus can negatively impact a patient's quality of life by disrupting their ability to concentrate, enjoy leisure activities and obtain restful sleep. Unfortunately, we currently have no drug therapy to offer these patients. I am excited about the potential of OTO-313 and pleased to be part of the Phase 1/2 clinical trial.”

 

Are they recruiting? Did you check on clinicaltrials?

 

Even if this drug is successful, which seems to work on the same theory of MoA as Auris Medical's AM-101 - which failed. We still have no idea if it will only be for acute tinnitus. Going by the science of it, for those of us have long term, established tinnitus, it ends up in the brain and starts in the ear. So treating the ear early on may work, but I have no idea what the science behind it would be if it was to be aimed at chronic tinnitus.

I tried to contact them to see if they’ll answer some questions but the 2 email addresses didn’t seem to be active.

 

Sorry if this might be a silly question but what is the difference between chronic and acute tinnitus?

 

Chronic tinnitus = suffering it for more than 6-9-12 months...it depends on which literature you choose.
Acute = less than that.

 

https://www.clinicaltrials.gov/ct2/show/NCT03918109?term=Otonomy&recrs=a&rank=2

They have posted the recruiting for the clinical trials.

 

How do you sign up? Can’t find the sign up

 

Email Andrea Velasquez at:

andrea.velasquez@worldwide.com

 

There are alot of people from different companies working on this and I know for a fact healing is possible. This should give us hope.

 

By "fact" are you referring to Korea specifically or to scientific breakthroughs generally? Or are you referring to all of the above. Is that an OK question to ask?

 

My own experience.

 

Sweet... thanks for your reply.

 

The trial has been posted, just thought I'd let everyone know!

 

How do you sign up though ?

 

My thoughts...

Just checked the recruitment on ClinicalTrials.gov...

There is no timeframe to how long you must have had tinnitus, whether it be over 3
months or 20 years....

This could mean that they have an idea that it may be helpful for both acute and chronic tinnitus. A conversation I had with @attheedgeofscience and a presentation he saw, given the figures they were talking about, it would suggest they are targeting both chronic and acute tinnitus.

OR

It doesn’t matter as the primary outcome by the looks of it and small sample size that they are just testing the safety of this drug.

Otonomy are difficult to get hold of, it would be great if Tinnitus Talk could have a Q&A with them. @Markku, @Hazel - I tried to contact them via the emails on their website and the email address appears invalid...

 

I guess there's nothing about Europe, eh?

 

Does anyone know if you need to be US citizen to sign up for this trial?

 

"Initial trauma to the inner ear has been shown to trigger excess production of glutamate, which leads to the hyperactivation of NMDA receptors and, in turn, cell death. Blocking the NMDA receptor could therefore have a protective effect – but it is unclear how this mechanism would work once the damage to hair cells had been done." - sounds like this is for acute T only, but they want to test that assumption