Otonomy Update at JP Morgan Healthcare Conference

[attheedgeofscience]

Today, Otonomy did a live presentation at the JP Morgan Healthcare Conference which served to update the market on what's to come in the year ahead. The presentation deck has received its largest overhaul to date and the slide containing the pipeline now looks like this:

The main points of the presentation were:

• A review of the recent AVERTS-1/2 trials for Ménière's disease (treating vertigo, not tinnitus). The AVERTS-1 trial (which was US-based) failed to meet its primary endpoint (vertigo days) while the EU-trial did not. The cause of the failure was explained during the presentation and also took up most of the Q&A-session. Essentially, the US-trial had a bias introduced due to the earlier phase-II trial also having been conducted in the United States. The consensus (among US doctors) when entering the phase-III trial was that the treatment works and it would appear that they – the physicians – may have prepped the patients in a biased way (i.e. "the treatment works!"). This was not the case for the EU-trial which had a neutral way of enrolling patients (as doctors had no prior experience with the intervention). The above led to a higher placebo-based response (in vertigo days) than should have been seen for the US-trial, and consequently, the difference in vertigo days (between placebo and drug) could not lead to a strong enough statistical outcome. A further phase-III trial is now being planned if it should be necessary to enroll additional patients in order to satisfy the FDA requirements needed to bring OTIVIDEX to market. Being a patient-reported trial, the study was especially susceptible to bias.
• OTIPRIO is scheduled to be divested but is still being sold.
• OTO-311 will be renamed OTO-313 as a new formulation has been discovered. Clinical trials (for patients, not healthy volunteers) expected to commence in 2019.
• The hearing loss programme has now been split into three bits: a treatment for hidden hearing loss (i.e. those who have a normal pure-tone audiogram but cannot hear conversations with background noise present) called OTO-413 (targets ribbon synapses), a treatment for oto-protection (this was previously supported by OTIVIDEX which has several uses but a new superior compound has been found) called OTO-5xx, and a treatment for hair cell regeneration called OTO-6xx. OTO-413 will be the first treatment to hit clinical trials in 2019. The hearing loss trials should not risk the same types of bias (as was seen from the AVERTS-trials) as objective measures will be incorporated for testing outcomes.
• Otonomy has sufficient cash to complete a future OTIVIDEX clinical trial and meet the next inflection points for the rest of the pipeline.

Presentation attached.

 

[Rubenslash]

In 10 years we will be choosing between different hearing regeneration treatments like we are choosing new cars now.

JK but this is definitely good news

I would have bought their shares if this wasn't such a competitive field.

 

[grate_biff]

God bless them. With all these compounds and disorders to work with, I say well done Otonomy!
Some good must come out of this!

 

[Mortzcent]

Woah I knew there are a lot of treatments in progress but that many, holy shit

 

[attheedgeofscience]

The presentation by Otonomy included a mention of two publications concerning global hearing loss rates. The commonly reported figure for disabling hearing loss was in the past reported to be 360 million people (globally). Revised figures from a 2017-review by The Lancet point to around half a billion of the world's population suffering from disabling hearing loss (with huge costs to society). The publication is paywalled and cannot be shared here, but for those interested, this is the abstract:

URL: www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31073-5/fulltext

 

[attheedgeofscience]

Otonomy has quite a line-up of presentations for the upcoming ARO summit this week. Specific topics will include information on OTO-413 (for hidden hearing loss) and OTO-313 (a new formulation of OTO-311 for tinnitus). There is probably no doubt – although others have disagreed with me – that Otonomy is setting "the standards" in the inner ear otology field. They have by far the most robust complete pipeline and a potent balance sheet (read: cash) to carry out their mission. At least, that would be my thoughts...

 

[undecided]

What makes anyone think that any of these treatments are going to be effective?
Especially that dexamethasone thing for menieres... That must have been tried for the first time around the middle ages and about a billion times after that. It's cortisone ffs.
I guess hope is hope - and so is a big fat sum of sponsor money for a company's 'research targets' and supposedly achieved 'milestones'. But money has to move around i guess.

 

[Paulmanlike]

Thank you @attheedgeofscience for your great input to this forum. I love your posts.

I wonder if this new information regarding oto-313 (as it's called now) we will finally get an answer if it's intended for both acute and chronic, long term tinnitus. I've had this burning question since I've heard about Otonomy and also am-102.

I also wonder what information they will give regarding things that may know that other people don't know about tinnitus, you know, I assume in a biotech/pharm company like this that they would not really share their own research in order to protect their 'product'? Would I be right in assuming that? Or give the full reasons why they think their product could work to tackle tinnitus and hidden hearing loss?

Regarding potentially buying shares in this company, would you invest in them ATEOS at this point or at any point?

 

[attheedgeofscience]

I wonder if this new information regarding oto-313 (as it's called now) we will finally get an answer if it's intended for both acute and chronic, long term tinnitus. I've had this burning question since I've heard about Otonomy and also am-102.

Well, we shall see. I would prefer not to speculate, but for what it is worth, I would not anticipate that the NMDA-receptor approach to treating tinnitus (through intratympanic injection) would yield potential for reducing/eliminating tinnitus of a chronic nature. The Wenzel study – which I have referenced before (like here) – considered patient case studies where high doses of gacyclidine where delivered under ideal conditions and did not result in a meaningful relief for those who participated (except one patient, if I recall correctly). But you also have to consider the patient profiles (etiology) as well in this instance. Still, I believe that the NMDA-receptor approach would yield a clinically meaningful result when considering:

• time of intervention (i.e. in the first few weeks after an auditory insult)
• repeated/long-term exposure (of the drug)

As an example, those who completed all open-label rounds of injections with AM-101 saw a statistically meaningful result (vs. those who just did the placebo-based trial). So all-in-all, there is evidence that the approach works – it's just a matter of fine-tuning when and how to treat...

I've had this burning question since I've heard about Otonomy and also am-102.

Well, AM-102 was after a long period of time finally revealed to be indicated for treating acute tinnitus (as well). This was actually something I brought to the surface a while back and would not have been publically available otherwise:

www.tinnitustalk.com/threads/auris-medical-am-102.7183/page-3#post-239074

Polo North Securities did do a review of Auris Medical some two years ago – surprisingly no one from the entire forum picked up on it (not then, and not during the entire time span since). Having said that, the review did have its flaws, but at the time, it did catch my attention for sure (and something that was the substance of conversation for several months in my personal group).

I also wonder what information they will give regarding things that may know that other people don't know about tinnitus, you know, I assume in a biotech/pharm company like this that they would not really share their own research in order to protect their 'product'? Would I be right in assuming that?

Well, both OTO-313 and OTO-413 are now "known". The technology behind Otonomy is of course the sustained exposure formulation of each of the product candidates and this is what Otonomy is "famous" for (because of the single intratympanic procedure and the potential this has for achieving therapeutic concentrations inside the cochlea for drug compound x, y, z...).

 

[Contrast]

I wonder if correcting hidden hearing loss will reduce the volume of tinnitus?
Dr Roland Schaette mentioned it being possible.

OTO-413 might be able to kill two birds in one stone.

 

[Paulmanlike]

I wonder if correcting hidden hearing loss will reduce the volume of tinnitus?
Dr Roland Schaette mentioned it being possible.

OTO-413 might be able to kill two birds in one stone.

Never thought of that, and it's probably the cause even for those with normal audiograms who have had noise exposure. (Like myself)

 

[VRZ78]

I wonder if correcting hidden hearing loss will reduce the volume of tinnitus?
Dr Roland Schaette mentioned it being possible.

OTO-413 might be able to kill two birds in one stone.

According to Charles Liberman it will also help for hyperacusis

 

[Autumnly]

 

[Paulmanlike]

View attachment 44461

This isn't new news. Just wondering if anything has changed however with Auris Medical's recent failure.