Otonomy OTO-311 Phase II Clinical Trial for Tinnitus

[Markku]

Later in 2017, Otonomy will proceed to phase II with their product candidate OTO-311.

We just finished a conference call with them; the trials will occur in the US and in the UK.

We are also going to arrange a Q&A where members can post questions about the trial and Otonomy answers what they can. More information about this when we're a little closer to the trial.

 

[acufenero]

Are they targeting both acute and chronic tinnitus or just acute tinnitus (like Auris Medical)?

 

[Markku]

Are they targeting both acute and chronic tinnitus or just acute tinnitus (like Auris Medical)?

Otonomy has made no decision on that as of now, more details will likely be available in September/October.

Likewise they haven't yet decided if people living outside the US or UK could regardless apply to be enrolled in the trials (should the participant be willing to travel).

 

[Kekistan]

How exactly will this trial help us with tinnitus?

 

[grate_biff]

How exactly will this trial help us with tinnitus?

 

[cviechec]

Seems interesting, as someone who is unfamiliar with this - is it an injection or what? Are the results promising?

 

[NatureHiker]

Seems interesting, as someone who is unfamiliar with this - is it an injection or what? Are the results promising?

Injection into the middle ear. This has only passed phase 1 clinical trials, so we can assume from this point just that it's safe to use. Phase 2 will test efficacy and we'll see then if this has a significant difference than a placebo and can actually treat Tinnitus.

 

[DoNotGoGentle]

Thank you for your inquiry regarding Otonomy's clinical trials for our tinnitus product candidate, OTO-311. The FDA has cleared the company's Investigational New Drug application (IND) for OTO-311. The IND clearance enables Otonomy to initiate a Phase 1 dose escalation clinical safety trial of OTO-311 in a small number of volunteers who do not have tinnitus. Timing for initiating a Phase 2 trial for OTO-311 in patients with tinnitus is scheduled for the end of this year. I am not able to address your other questions as the protocol has not been completed.

If you are interested, you can add your name to a database to receive future communications from the company related to clinical trials and program updates by registering here.

If you would like to receive alerts of news announcements from the company, you can register for alerts on the Otonomy website.

For information about other trials available for tinnitus patients, you can periodically check the clinicaltrials.gov website, searching for "tinnitus" to identify trials that are enrolling.

Regards,
Dean Hakanson MD
Chief Medical Officer​

Emailed them and that is what they said.

 

[Paulmanlike]

I speculate that is for acute tinnitus only. As of the Auris medical website in the Q and A one parts states

"More recent theories assume that, while it starts in the ear, the tinnitus becomes "centralised" in the brain over time, where it can persist even if the original damage is no longer present in the inner ear. Since the chances of a cure for this type of permanent tinnitus are very low, attempts are being made to treat the tinnitus at an early stage, focusing on the inner ear."

Also, ATEOS states that also AM-102 will again be for acute. I also read that OTO-311 will again be for acute. (From rnid)

 

[Paulmanlike]

"Another biotech company, Otonomy, has begun testing its new drug, OTO-311, for early stage tinnitus. "

https://www.actiononhearingloss.org...-guest-blog/research-to-silence-tinnitus.aspx

For early stage tinnitus....

 

[Phendran]

"Another biotech company, Otonomy, has begun testing its new drug, OTO-311, for early stage tinnitus. "

https://www.actiononhearingloss.org...-guest-blog/research-to-silence-tinnitus.aspx

For early stage tinnitus....

This here is concerning.

It's super-important that people who've had T for many many years also can get treated.

 

[Paulmanlike]

This here is concerning.

It's super-important that people who've had T for many many years also can get treated.

It is, but reading between the lines it looks like neither Auris nor Oto are targeting chronic tinnitus. Reading the science behind it, it looks as if to stop the tinnitus setting in and most of us here are far beyond that stage. AM-102 is also for acute tinnitus. I hope Markku can confirm this on the Q&A with them with OTO-311.

 

[walkthroughwalls]

This here is concerning.

It's super-important that people who've had T for many many years also can get treated.

Concerning, really?
Sure, everyone should have a cure, but you'd have to start somewhere...

 

[flobo]

This make me want to keep taking benzos a few times a month.

Maybe it's absolutely stupid, but I think if my brain has days without tinnitus a few time a month with benzos, then maybe tinnitus can stay acute.

 

[jer]

i would like to add that the acute vs chronic debate has not been settled. They just don't know how long the acute stage is. They don't know if there even is even a difference between the acute and chronic stage, or if it is just all the same. They have done some studies and there are suggestions for certain things, but by know means are the researchers clear on this.

 

[Pleasure_Paulie]

i would like to add that the acute vs chronic debate has not been settled. They just don't know how long the acute stage is. They don't know if there even is even a difference between the acute and chronic stage, or if it is just all the same. They have done some studies and there are suggestions for certain things, but by know means are the researchers clear on this.

Correct. The debate of if a permanent a neuroplastic change occurs in the brain as a result of Tinnitus onset is certainly not fully understood. Unfortunately the heterogeneity of tinnitus is not either.

 

[vermillion]

Today's Otonomy's news.

Additionally, no clinical trials will be initiated during the remainder of this year. Timing for initiation of a Phase 2 clinical trial of OTO-311 (gacyclidine) in tinnitus puatients and a Phase 3 registration trial for OTIPRIO in pediatric patients with acute otitis media with tympanostomy tubes (AOMT) will be evaluated as part of the pipeline review and prioritization effort now underway.

We have a tremendous opportunity to utilize our experience, expertise, and resources to address important unmet medical needs such as hearing loss and tinnitus, and I look forward to outlining our plans in future business updates," added Dr. Weber.

 

[Onsdag]

Today's Otonomy's news.

This is PR lingo so their investors wouldn't all disappear. Do you think Otonomy will go under?

 

[Rubenslash]

This is PR lingo so their investors wouldn't all disappear. Do you think Otonomy will go under?

Of course not, they have cash until 2020.

And this is how biotech works, if one of their products fail it doesn't mean the company will suddenly stop operating...

 

[Paulmanlike]

This is PR lingo so their investors wouldn't all disappear. Do you think Otonomy will go under?

They've got several other medicines in the pipeline and hair cell regeneration in the future, I think investors should hang on for the long term. They're obviously pursuing their strategy!

 

[attheedgeofscience]

This article looks into the effects of the phase-III trial failure of OTO-104 (OTIVIDEX) and how other clinical trial programmes will be delayed in a restructuring exercise initiated to build shareholder value:

www.fiercebiotech.com/biotech/otonomy-axes-staff-hits-brakes-r-d-after-phase-3-flop

OTO-311 is specifically mentioned. Of course, if past events (AM-101/AUT63) are anything to go by, then this piece of news should fit right into the lineup of mishaps. I guess most people here are used to bad news, therefore. And on that note: how many of you have donated to tinnitus research... like... recently? Or... at all? And if not, why not?

 

[Jim51042]

@attheedgeofscience thanks for the article.
what the f**k is Otonomy doing?? Why does their sale team comprise 30% of their staff (40/139)? Are they a bio tech company or a QVC team pitching bs.

On that topic how is it useful to shutdown/delay trials of future product lines? What are they going to sell? If they had something useful for phase 2 trial last month why is it now not worth testing? Who the f**k is running this joke of a company. Sorry but the management of this company is moronic!!

 

[attheedgeofscience]

@attheedgeofscience thanks for the article.
what the f**k is Otonomy doing?? Why does their sale team comprise 30% of their staff (40/139)? Are they a bio tech company or a QVC team pitching bs.

On that topic how is it useful to shutdown/delay trials of future product lines? What are they going to sell? If they had something useful for phase 2 trial last month why is it now not worth testing? Who the f**k is running this joke of a company. Sorry but the management of this company is moronic!!

I have followed Otonomy for quite a while (and participated in a number of their investor conference calls throughout the past 18 months or so). I have for a long while considered them the more seasoned/competent entity out there due to their sustained release formulation pipeline of drugs (which potentially is quite important for effective inner ear treatments - it is not just patient friendly). This thermo-sensitive application has really been something they have spent years and years perfecting (they had to redo the gel for OTO-311 to get the thermo-sensitivity just right and released a separate patent on that).

I am also disappointed about the developments (on behalf of those who suffer from inner ear conditions). However, I still consider both Mr. Weber and Mr. Meyer highly competent CEOs who must master a whole variety of topics in their respective capacities as managers of their companies: right from being opportunistic about possible new developments to managing capital (read "financial runway"), to understanding the complex science of inner ear disorders, to running clinical trials, to dealing with conservative doctors who are not especially eager to move on to newer technologies and so forth and so forth.

At the end of the day, companies exist to make a profit. To the extent that we want newer technologies to the market for conditions with unmet needs, it is the responsibility of governments to ensure that early stage research becomes mature enough (viable enough) so that private investors are willing to throw money at it. So the real culprit here continues to be politicians and governments (and ourselves as private donors to tinnitus research organisations like TRI, the ATA, the BTA, and the HHF). Hope that helps...

 

[nills]

This here is concerning.

It's super-important that people who've had T for many many years also can get treated.

You have to apply to test something.. if it works early stage it might work for all, not other way around. It's a bureaucratic thing.

 

[Paulmanlike]

I think there's going to be a long and bumpy road ahead for Otonomy, with potentially many set backs in the future. Whether that be challenges in Science, Investor confidence and all the other obstacles associated with it.

However, I believe that if these guys can steer through it all, they will succeed in a very lucrative market. They have a broad range of developments in the pipeline, I haven't seen anything as broad from anybody else.

Their strategy makes sense and we are all rooting for them; patients, investors etc
I just hope they continue to manage the set backs and pursue the accomplishments.

 

[acufenero]

Otonomy Announces Plan to Focus Resources on Development Programs

Key Elements of Business Plan

[...]

Advance Development of Multiple Programs for Hearing Loss and Tinnitus: Otonomy plans to continue the development of multiple programs for the prevention and treatment of sensorineural hearing loss, and the treatment of tinnitus. The hearing loss programs, currently in preclinical development, involve the anatomical and functional repair of ribbon synapses, protection of hair cells from chemotoxicity, and regeneration of hair cells. Otonomy is also developing gacyclidine, a potent and selective NMDA receptor antagonist, for the treatment of tinnitus. Hearing loss and tinnitus affect large patient populations and are important unmet medical needs because they have a significant burden on patients and lack effective treatments.

 

[vermillion]

The hearing loss programs, currently in preclinical development, involve the anatomical and functional repair of ribbon synapses, protection of hair cells from chemotoxicity, and regeneration of hair cells. Otonomy is also developing gacyclidine, a potent and selective NMDA receptor antagonist, for the treatment of tinnitus. Hearing loss and tinnitus affect large patient populations and are important unmet medical needs because they have a significant burden on patients and lack effective treatments.

Yes please, and if it's possible in this lifetime. In any case, yes please. We are still left hanging by dr. Josef Rauschecker's words of conclusion: "Help is on the way". Let's just hope it's not gonna be like Beckett's Waiting for Godot...
Fingers crossed for Otonomy!

 

[Paulmanlike]

@vermillion just to clarify - Rauschecker didn't actually say "help is on its way" he said something along the lines of "I wish I could reply to emails and say help is on its way" - Sorry, but I just needed to clarify that.

@Markku Is there any date when you are doing a Q&A with Otonomy regarding OTO-311?

I've had this burning question since I found out about OTO-311 - is it aimed at chronic or just acute? @Aaron123, I know you probably do. It doesn't have a definite answer on this but what do you think? (You are highly respected for your knowledge on research in this area by this community and I would appreciate your thoughts)

Hope everyone is well.

 

[just1morething]

I think there's going to be a long and bumpy road ahead for Otonomy, with potentially many set backs in the future.

Seems so when their stock dropped 80% awhile back. Not a good sign and if OTO-311 is a similar formulation as AM-101 as I've heard that doesn't sound good either. They seem to be dragging out the trial later and later.

 

[threefirefour]

Seems so when their stock dropped 80% awhile back. Not a good sign and if OTO-311 is a similar formulation as AM-101 as I've heard that doesn't sound good either. They seem to be dragging out the trial later and later.

Fully agree. I don't think OTO and AM-101 are the answer. Freq. theraputics and Trobalt remake seem like the key areas to be focusing on.