Otonomy OTO-313 — Treatment of Tinnitus

[Nobody19]

If someone could save me from scanning the length of this thread, when is the Phase 2 trial presumed to begin?

From their presentation:

Expect to initiate Phase 2 trial in 1Q21 with results mid-2022.

 

[AfroSnowman]

From their presentation:

Expect to initiate Phase 2 trial in 1Q21 with results mid-2022.

I don't see anything about it on clinical trials page. I hope it is still going on as planned.

 

[MRItechssuck]

Am I mis-remembering.....did @ChrisBoyMonkey have an adverse reaction in the first 313 trial?

I took a break from the site when he was trying to find out if he had the real thing, or a placebo....

thx

 

[Ali.sy]

Where are the results of OTO-313?

 

[FGG]

Where are the results of OTO-313?

Top line results here:

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus

 

[dd314]

Top line results here:

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus

Interesting that for Phase 2, they aren't upping the dose, only changing the criteria to exclude hearing loss and increase minimum TFI. That should beat the 43% responder rate reported here.

 

[Tezcatlipoca]

Top line results here:

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus

 

[Tezcatlipoca]

@FGG, what are the cons of OTO-313? Does it deplete support cells?

 

[FGG]

@FGG, what are the cons of OTO-313? Does it deplete support cells?

It's not a regenerative drug so no. The main con would be that so far, it has only been tested on acute cases (under 6 months). It is unknown if it works chronically but the company intends to use a longer time period (unknown how long) for the next trial.

 

[reggie green]

Well that's good news at least from one company.

 

[Tezcatlipoca]

It's not a regenerative drug so no. The main con would be that so far, it has only been tested on acute cases (under 6 months). It is unknown if it works chronically but the company intends to use a longer time period (unknown how long) for the next trial.

Why wouldn't it work for chronic tinnitus?

 

[FGG]

Why wouldn't it work for chronic tinnitus?

Some people speculate whether or not there is a window for cochlear NMDA receptor antagonists to work because it has a lot to do with initial cochlear response to inflammation but there is also some evidence at least for some people it may work chronically too. So it's really unknown atm. Something the next trial may address.

 

[Croaker]

Some people speculate whether or not there is a window for cochlear NMDA receptor antagonists to work because it has a lot to do with initial cochlear response to inflammation but there is also some evidence at least for some people it may work chronically too. So it's really unknown atm. Something the next trial may address.

If only we knew the mechanism behind setbacks. I wonder how Dr. Fuchs and his animal model are coming along.

 

[Gb3]

It's not a regenerative drug so no. The main con would be that so far, it has only been tested on acute cases (under 6 months). It is unknown if it works chronically but the company intends to use a longer time period (unknown how long) for the next trial.

I was told one year.

This is when I called about the FX-322 trial.

 

[wwtsai]

Hopefully Otonomy is still on target to initiate their Phase 2 in Q1 since it ends in a week.

 

[Philip83]

https://investors.otonomy.com/static-files/5d9cb779-996b-49b3-b162-8285d00b6e71

So both OTO-313 and OTO-413 results from upcoming phases expected for mid-2022.

 

[wwtsai]

Not up on ClinicalTrials.gov yet.

Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus

 

[Philip83]

Not up on ClinicalTrials.gov yet.

Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus

Great news! In my opinion a 12 month onset window can basically be counted as chronic, can it not? My chronic increases usually have "settled" to a steady level after about 6 months. At 12 months I'd say it's definitely "stuck".

 

[dd314]

Local NMDA receptor blockade attenuates chronic tinnitus and associated brain activity in an animal model

 

[Jcmc]

Interesting that for Phase 2, they aren't upping the dose, only changing the criteria to exclude hearing loss and increase minimum TFI. That should beat the 43% responder rate reported here.

That only makes you think that it will be a failure.

 

[weab00]

Not up on ClinicalTrials.gov yet.

Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus

Hopefully they take notes on the disastrous FX-322 trial and change their methodology accordingly.

 

[Zugzug]

Interesting that for Phase 2, they aren't upping the dose, only changing the criteria to exclude hearing loss and increase minimum TFI. That should beat the 43% responder rate reported here.

Here we go again... you need a minimal TFI level to be selected. Where have we seen this before?

This one doesn't even need bad actors. Literally the stress of having high enough TFI to get in could actually inflate TFI at baseline, lol.

 

[Guywithapug]

Here we go again... you need a minimal TFI level to be selected. Where have we seen this before?

This one doesn't even need bad actors. Literally the stress of having high enough TFI to get in could actually inflate TFI at baseline, lol.

 

[Tezcatlipoca]

Here we go again... you need a minimal TFI level to be selected. Where have we seen this before?

This one doesn't even need bad actors. Literally the stress of having high enough TFI to get in could actually inflate TFI at baseline, lol.

So is this dead?

 

[Jcmc]

So is this dead?

I guess this is a dead end.

 

[rid0871]

Does anyone know when the OTO-313 Phase 2 clinical trial starts? I can't find it on the ClinicalTrials.gov page.

Thanks.

 

[Mentos]

Does anyone know when the OTO-313 Phase 2 clinical trial starts? I can't find it on the ClinicalTrials.gov page.

Thanks.

They just announced initiation of Phase 2, and apparently it will be conducted also in Europe:

Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus

The fact they plan trials in Europe gives me hope they will test OTO-413 there as well.

 

[MRItechssuck]

@FGG, didn't @ChrisBoyMonkey have a bad reaction to OTO-313? I thought he was trying to see if he got the placebo or real thing to be sure and I went on sabbatical from here before I learned the outcome... maybe you recall?

At the time I was thinking of doing the first study, then read his reports (if my memory is working correctly). I chickened out for that first trial, hoping things would settle down (insert face palm here).

Thanks

 

[FGG]

@FGG, didn't @ChrisBoyMonkey have a bad reaction to OTO-313? I thought he was trying to see if he got the placebo or real thing to be sure and I went on sabbatical from here before I learned the outcome... maybe you recall?

At the time I was thinking of doing the first study, then read his reports (if my memory is working correctly). I chickened out for that first trial, hoping things would settle down (insert face palm here).

Thanks

We never got an update as far as I know...

 

[Jimmyboi]

Does anyone know where they usually publish the information to be involved trials?

If it's rolling out in Europe I'd definitely like to take part.