Otonomy OTO-313 — Treatment of Tinnitus

Anymore updates on this, @Sentinel?

 

Well, that's an important point for all of us old-timers. You should view this as a happy curiosity. Spontaneous Remissions happen usually within the first three months -- that's what they used to say, anyway. After that with each passing day the chances of a reprieve get less and less. So they make the distinction between acute tinnitus and chronic tinnitus.

 

Nope, still the same new low.

 

I’m gonna be rip shit if this doesn’t work for people past one year. I would have missed it by two years then.

 

Otonomy is up 10% today at more than twice the normal volume?

 

Has there been an announcement or write up in the financial press on Otonomy's stock price increase? Is it related to some positive trial result?

Also, does anyone know if the OTO-825 gene therapy treatment can help tinnitus?

 

By the time OTO-313 comes out, we will all be out of the one-year window?

 

It is intended to treat hearing loss, so if it works as intended, maybe it would help with tinnitus.

 

Absolutely yes—Phase 2 results alone will take a year to be released. Then factor in the time it takes for Phase 3 to start and then the time it takes for the drug to be commercialized if all is successful.

That said, Otonomy's hope is that the drug can be effective for those who have had chronic tinnitus for over a year. The 6-month/one-year trial requirements were put in place to make drug effectiveness more evident in the trials (i.e., it's easier to treat an early case of something rather than a chronic case), yet Otonomy plans to expand this window in future trials once confident enough to do so.

 

1 year window is there to increase chances of OTO-313 to succeed. It does not mean it won’t work beyond 1 year window, we simply don’t know.

 

Stock price is probably part of an ETF, everything ripped today.

Not that Otonomy isn't a good gamble buy before the study is done.

Remember temporary improvements don't mean much, we get that with steroids.

The real data comes on at the follow up, 1/2 a year later at the least.

 

Hope so. I hope OTO-313 can help everyone. I've had my tinnitus now for 20 plus years and pray for silence before I cash in my chips.

 

Phase 3, I'm guessing, will probably include patients with bilateral tinnitus and those who have had it for longer than a year. I'm interested to know if OTO-313 will work for patients with severe hearing loss but I guess we'll have to find out later.

 

I would take an injection if it lasted for months and no harm done lol.

 

It was oversold, which is why it jumped. If you look at the chart over the past month, you'll see it's gone down like ~30%.

The stock price almost seems like it's being manipulated. I bought a small amount at 2, and even though I feel like it'll go up sometime mid next year, I'm not willing to buy any more. BioTechs are just too risky.

On a possibly related note, Otonomy had 6 jobs listed 2-3 weeks ago on their LinkedIn. Today they have none. So it looks like they went on a mini-hiring spree. Not sure what that was about.

 

@Sentinel, any update?

 

Otonomy gave a virtual presentation today at the HC Wainwright Investment Conference. For anyone interested I took the following notes:

OTO-313

• They've tightened up the entry requirements (no severe hearing loss patients, patients must have tinnitus for 2 months).
• They're testing for a longer period (3-4 months). They think 1 dose may have the potential to cure some people.
• If there is success in the Phase II trial it can possibly serve as a pivotal trial. (2 pivotal trials are typically needed for FDA approval)

OTO-413

• Many people in the study have hearing aids but don't use them because they don't help them.
• The interviewer asked them about Frequency Therapeutics’ FX-322 data vs their OTO-413 data, they said their data is much stronger. They also talked up the importance of words in quiet vs words in noise.
• The interviewer asked them if they can go straight into Phase 3 if there's success in their extended Phase I/II trial. They responded that if the data is compelling they can enter into a Phase II/III trial.

There was no discussion on OTO-6XX (probably due to time), and only a few brief words on OTO-825 (also most likely due to time). Overall Dr Weber seemed pretty enthusiastic. The idea of going straight into a Phase II/III seemed kind of exciting.

 

Was there anything in the presentation about the theory that it will help in just the early onset? Or any idea if it can help people who have had tinnitus for longer?

 

They are not sure. For this phase they will only test in people with an early onset, in the next phases they may increase the time of tinnitus onset.

We will only know when they test it with people with long-term chronic tinnitus.

 

Regarding OTO-313, I don’t understand the part about "testing longer period of time (3-4 months)".

I thought they were giving it to everyone that have had tinnitus for less than a year?

 

Great work @patorjk.

It's great to see this thing in motion. And perhaps what makes it more exciting is that this is entrepreneurship "in motion" towards a cure or at least a therapy -- not simply a research paper. Aalthough the latter are vital too. We are missing the knowledge base and it has to be built up.

But back in the 90s when my tinnitus hit, it was already known that most remissions (cures) occurred within the first three months. As a matter of fact they used to say "Go in to the hospital straight away. Every minute counts".

So Otonomy are excited about the progress with OTO-313. If it can up the number of remissions of the onsets within the last three months, well great.

And don't forget us poor punters who have gone chronic when charity time comes around.

Ah yes. There was an elegant description back then that I made a note of.

"Spontaneous remissions occur most often within the first three months. Then with each passing day the chances of remission get less and less. And after six months? One year? It's described as chronic tinnitus."

 

If I'm not mistaken, tests and assessments are usually done for 2 months after exposure to the drug. This time they will be increasing that up to 4 months.

The trial does still cater for patients who has had tinnitus for up to 12 months.

 

I'm getting there... five and a half months now and not really better.
Then it becomes more of a brain problem? So sad...

Still have some hearing loss too it seems, so I guess it becomes both ear and brain.

 

One interesting thing they're doing for their Phase II study is classifying the patients into 2 groups: Those who have had tinnitus for less than 6 months, and those who have had it for between 6 months and 1 year. If the 2 groups perform equally as well than it may mean this drug works for a significantly large part of the patient population. Their Phase I study only tested the drug against people who had tinnitus for less than 6 months, and I remember them saying they didn't see any tapering of benefit for the people in that study, which is why they're extending the time-frame for Phase II.

I've never bought into the "tinnitus moves into the brain" hypothesis that seems to be popular in the medical community. My gut is that they'll discover this drug works for everyone. However, that's a very optimistic viewpoint. We'll have a better idea of what it can do in a year's time.

 

Tinnitus still has remained low and not returned to anything approaching pre-administration levels. I'm about to reach the 1 year anniversary of the acoustic trauma that set it off too.

 

Sorry, me again...

When I read this about OTO-313 and tinnitus:

N-Methyl-D-Aspartate (NMDA) receptor antagonists
shown to reduce the over-activation of auditory
nerve fiber signaling that results from the injury.

From page six in the Otonomy Corporate Presentation here:
https://investors.otonomy.com/static-files/cbfbff99-5fa0-47d4-a1f7-264895557267

I just feel that describes what my tinnitus is like – it sounds electrical. The other week I was in a parking house were several electrical cars was standing in a row connected to their charging boxes and the high pitch electrical sizzle sounded quite a lot like my tinnitus.

Back in the beginning of May I could actually hear the onset of my (latest) tinnitus take place in my left ear – from no tinnitus I heard a sort of ”warped chirp” for two or three seconds that faded out (I imagine this was the sound of synapses ”disconnecting” from their hair cells – would be interesting to have that confirmed somehow) into a high pitched tinnitus hiss/sizzle that sometimes oscillates up in pitch and then goes back to baseline.

I just feel sad if I will miss the opportunity of OTO-313 helping me to at least lower the sound volume of my tinnitus. Four and a half month in now (sorry, typed five and a half in my previous post). I'd say the volume is moderate, but the high pitch is piercing and the oscillation really doesn't make habituation easier.

Hope the drug will help for long term sufferers too.

Anyway, really happy to hear that you seem to be in a better situation @Sentinel.

 

I think that there wouldn't have been much discussion on OTO-825 or OTO-6XX because they are also actually not out of the pre-clinical work phase as yet either.

 

My tinnitus reacts to my car's inverter when I accelerate hard (high frequency low volume whine), and to its pedestrian warning hum. Sometimes I get beeps or whistles over the charging station's sounds, too, and in very rare cases, electrical crackling, which is probably just hearing loss (I hear it at 8 and 16 kHz when I do a quiet frequency sweep, it's faint, but definitely there, present over the tone that is playing).

I am 3.5 months in with persistent worsening. I think OTO-413 is a better choice for me as I do have synaptopathy. Regardless, OTO-313 may help so many people and it's a step in the right direction!

 

OTO-825 is in pre-IND. They had a pre-IND meeting with the FDA earlier this summer and they expect to file the IND application in the first half of 2023. If they had more money I imagine that would be happening much sooner. My assumption is that they're going to issue more stock after the results of the OTO-313 and OTO-413 trials to raise money. Though they may also do this in the run-up to the results to make sure they can survive a failure. With this additional money they'll fund the pivotal trials for those drugs as well as the Phase I trial for OTO-825.

If they can get OTO-6XX working that will be their crown jewel.

 

My tinnitus behaves the same, when I accelerate I hear a ringing as if it was coming from the motor of my car. So weird.