Otonomy OTO-413 — Treatment of Hidden Hearing Loss

They don't know - they're studying it right now to determine that.

 

One thing is if it is the case that doctors see that they can make money off of something that they are currently not doing, then there tends to be every chance that they'll take it on.

 

So any idea how long these studies take to achieve some results that they can give a definite answer to? I'm just extremely impatient to try anything that may help me in any respect.

 

Offhand, I believe they're recruiting right now for a trial evaluating it for people who have had tinnitus for over 6 months (vs the initial trial with onset within 6 months). So that trial has to run its course.

Others here might be better qualified at putting an actual timeline on it, but I've copy/pasted a paragraph from their website below discussing it.

I too am extremely impatient to try anything that may help... we take it day by day knowing that there are drugs in the pipeline that may finally help and can't arrive soon enough!

• OTO-313: Phase 2 trial design to be based on the successful Phase 1/2 trial, and initiation is expected in the first quarter of 2021. In July 2020, Otonomy reported positive top-line results from a Phase 1/2 trial of OTO-313 in patients with unilateral tinnitus of at least moderate severity. This trial demonstrated a positive clinical response for a single intratympanic injection of OTO-313 using the Tinnitus Functional Index (TFI) that was correlated with tinnitus loudness, tinnitus annoyance and patient global impression of change measures. Based on continued analysis of this data, input from key opinion leaders, and feedback from the FDA in a Type C meeting, Otonomy intends to evaluate the same dose for OTO-313 in a Phase 2 trial that will enroll an enriched unilateral tinnitus patient population. To enrich the study population, Otonomy intends to exclude patients with severe hearing loss and increase the minimum TFI score required for entry. The company will also expand the unilateral patient population eligible for enrollment by increasing the time from tinnitus onset, and will extend the observation period to assess durability of the treatment effect.

 

I'm sorry to hear about your experience, and would imagine all of us with tinnitus have experienced that to some extent.

However, fundamentally, I believe that doctors want to help their patients, and I've talked to a number of them who are very excited about the potential of all these drugs in the pipeline, particularly regenerative medicine which stands to revolutionize treatment for many conditions.

And if you do encounter a Debbie Downer who doesn't seem all that interested in treating you, and doesn't seem all that interested in the innovative treatments on the horizon, particularly if one becomes available, I'd fire that doctor and find one who is!

 

That's a huge bummer that they are only recruiting >6 months group. I was looking all over to see if I could get into the trial. I'm about 40 minutes away from their headquarters.

 

To clarify, I don't believe it's an over-6-months-ONLY group. It's just that, compared to the previous trial, which excluded people who had tinnitus for more than 6 months, this one is open to them as well.

But my understanding is that it continues to be open to people who've had tinnitus for less than 6 months. I'm not positive, but I believe this is the case.

So you would likely qualify (assuming you meet their other criteria).

 

Ohhhh I think I'll try contacting them then, or is there a place online to sign up?

 

I'd like to get into the trial as well, but seeing I live in Australia and the trial in is the U.S with the current circumstances, just getting to the trial, if I was accepted, might be a tad tricky right now. Also the ClinicalTrials.gov site lists the current recruitment status as "completed".

 

You're probably looking at the previous trial, which is completed, not the current one, which is just starting up and might not be posted yet.

 

There's a couple of ways to approach this. One is to contact the company and ask them for information about joining the trial, and they should point you in the right direction.

The other is companies like this typically partner with doctors and medical facilities, and if you connect with one of those, they too can start the process. The company, in fact, might just point you to one of those facilities.

I don't see the new study posted yet on the gov't website, but if you look at the study they just completed, and scroll down, there's a section called "Contacts and Locations." I wouldn't be surprised if this information will be similar or the same:

https://clinicaltrials.gov/ct2/show/NCT03918109

 

Thank you for the help.

 

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Otonomy's stock is up 11% since yesterday afternoon. It is unusual for them to jump like this. Someone on Twitter was saying a bunch of $5 call options were purchased for January - which I believe gives someone the right to purchase the stock at $5 at a future date. Not sure if other people know something we don't or if people are just getting excited for the results. However, the unusual activity may mean that OTO-413 results are imminent.

 

They planned for OTO-413 results in December. Most likely will come before Christmas. Probably people buying in on speculation.

 

That'll make a hell of a Christmas present.

 

Late to the party on this one so I apologize if I'm asking a redundant question on this thread, but considering OTIVIDEX is in the Phase 3 trials and has a potentially better prospect of being released sooner than other drugs such as FX-322, any idea if this drug may prove useful for people suffering from tinnitus without Meniere's?

 

I suspect it would be useful for people with auto immune ear disease as well.

 

But no dice for plain old NIHL?

 

I think it will be more useful acutely. But there are always a few people who respond to steroids more chronically and this one has a lot more potential in that regard.

 

So as I read it, and please correct me if I'm wrong, the focus at this time is unilateral tinnitus? This interests me as that is what my tinnitus is... in right ear.

 

For OTO-413, the clinical trial is only testing one ear for the purposes of the trial but that's a standard design. It can be used on both.

 

Do you guys think the results will be out this week?

 

One would think... this is the last real week of the year for PR to have any impact until Q1, 2021.

 

I'm hoping so, however, they last updated their study on September 14th saying they were no longer recruiting:

https://clinicaltrials.gov/ct2/show/NCT04129775

My guess is they wouldn't do this until the last person they recruited started the trial. The trial is 12 weeks, so that would mean they got the data last Monday. When they got the OTO-313, they processed it for 3 weeks before releasing it, however, I don't think they'll take as long with OTO-413 (otherwise they'd be releasing it on the 28th).

If you search Twitter for their ticker symbol ($OTIC), you'll see some interesting chatter about peculiar option and stock buys [1, 2]. It looks like traders believe the results will be very soon [3]. Maybe this is fueled by people just being optimistic, or maybe it's a mix of that and some people knowing something.

 

It will be a shame if the results come out next year instead of this month.

 

Their latest corporate presentation - as of December 2020, states that they will be releasing OTO-413 results in 4Q 2020. So I assume they are still on track for this.

https://investors.otonomy.com/presentations

 

Early Christmas present.

 

Results for the Phase I/II trial of OTO-413 are in, they saw positive results:

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413 in Patients with Hearing Loss

Presentation:
https://investors.otonomy.com/static-files/b9c45563-9e81-423d-8eb9-c12f103c56ac

 

That's great that it works. I imagine it will work even better if both ears are treated because in general you need both for speech in noise.