Otonomy Q1 2019 Financial Results & Business Update

[attheedgeofscience]

It's been a while since I have shared any pharma news here on the forum, but today, Otonomy held its Q1 2019 conference call on the results for the period while providing a business update at the same time. The update was designed so as to have a special focus on OTO-313 (a treatment for tinnitus). For the first time, hereby a meaningful update on the programme and news not shared before:

• OTO-313 is a superior formulation of OTO-311 where both the potency of the drug and the exposure to the drug is increased through a single intratympanic injection (as much as a month worth of exposure is provided due to the slow-release formulation; in comparison, AM-101 provides just about a day's worth of exposure)
• Inclusion criteria for the patient profile are not revealed due to the huge unmet need for the patient population (i.e. patients might try to falsify their patient history/symptoms to enter the trial was the implication, I guess...). A certain minimum TFI score is required to enter the trial as are more "recent cases of peripheral tinnitus" (implying: not patients with 5-10 years worth of chronic tinnitus). But again, no exact criteria are publicly disclosed.
• Superior pharmacokinetic properties compared to Esketamine (AM-101).
• Preclinical (and a small bit of clinical) evidence from NeuroSystec provide evidence of efficacy.
• The 2nd half of the phase-I/II trial is about to commence.

The results of the combined phase I/II study are expected in the first half of 2020.

Presentation attached.

Disclaimer: the information above is provided from memory of the webcast (but should still be "99% accurate"...)

 

[Jack Straw]

Good to hear!

 

[annV]

Inclusion criteria for the patient profile are not revealed due to the huge unmet need for the patient population (i.e. patients might try to falsify their patient history/symptoms to enter the trial was the implication, I guess...).

Does this follow Auris Medical's AM-101 trial where patients lied about how long they had had tinnitus just to get accepted into the trial?

 

[just1morething]

Otonomy's stock is doing

so investors' confidence must be low.

 

[urgentresearch]

OTO-313 is a superior formulation of OTO-311 where both the potency of the drug and the exposure to the drug is increased through a single intratympanic injection (as much as a month worth of exposure is provided due to the slow-release formulation; in comparison, AM-101 provides just about a day's worth of exposure)

• Inclusion criteria for the patient profile are not revealed due to the huge unmet need for the patient population (i.e. patients might try to falsify their patient history/symptoms to enter the trial was the implication, I guess...). A certain minimum TFI score is required to enter the trial as are more "recent cases of peripheral tinnitus" (implying: not patients with 5-10 years worth of chronic tinnitus). But again, no exact criteria are publicly disclosed.

Here is the inclusion criteria from the OTO-313 study page, if anyone is curious:

Inclusion Criteria:

• Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
• Subject is able to use the electronic diary to complete their daily tinnitus ratings
• Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
• Subject is willing to comply with the protocol and attend all study visits.

Exclusion Criteria:

• Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
• Subject is pregnant or lactating.
• Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

 

[attheedgeofscience]

Does this follow Auris Medical's AM-101 trial where patients lied about how long they had had tinnitus just to get accepted into the trial?

The Otonomy team themselves experienced the difficulties related to conducting a clinical trial based on subjective assessments (as was the case with OTIVIDEX). I covered it here.

Bringing tinnitus treatments to the market is a problem due to the inability to define a standardized patient profile that might reflect what the drug/therapy/intervention is aiming to treat. Until resolved, it could mean that many more treatments might fail (not because they don't work, but because they cannot be proven to work...).

Indeed, a number of patients who entered the clinical trials of AM-101 lied about their exact condition in order to not become rejected. This has consequences. In the end, the inability to prove a treatment works could lead investors to spend their money on more safe investment opportunities. So... this is not a unique problem for Auris Medical. Actually: it is a problem for all treatment providers (and therefore also very much for the patient population, in the end...).

Incidentally, hoping a treatment works (while experiencing the effects of severe tinnitus) can lead a significant proportion of people to "I want to believe" in it. Hope and despair, with no treatment options available, have a unique effect on individuals. Just search this forum for all the members who claim to be successfully habituated...

 

[attheedgeofscience]

Here is the inclusion criteria from the OTO-313 study page, if anyone is curious:

Inclusion Criteria:

• Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
• Subject is able to use the electronic diary to complete their daily tinnitus ratings
• Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
• Subject is willing to comply with the protocol and attend all study visits.

Exclusion Criteria:

• Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
• Subject is pregnant or lactating.
• Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Noted. But those criteria above, do not relate to chronicity or severity (which was what I was addressing; I guess, I could have been more clear about that, sorry).

 

[urgentresearch]

Noted. But those criteria above, do not relate to chronicity or severity (which was what I was addressing; I guess, I could have been more clear about that, sorry).

Not a problem - I should have clarified that my post wasn't to contradict or update what you reported regarding them not revealing inclusion criteria - just wanted to add context!

 

[Clint Azzopardi]

Is OTO-413 and FX-322 trying to do the same thing?

 

[FGG]

Is OTO-413 and FX-322 trying to do the same thing?

No. Fx-322 regrow hair cells and Oto-413 is attempting to repair synapse connection in "hidden hearing loss" which may actually be the source of tinnitus and hyperacusis is "normal hearing" ears.

Any theories on prospects for Oto-413 and whether BDNF application can actually repair these synapses?

 

[Clint Azzopardi]

Wohoooo OTO-413 should fix me then

 

[Paulmanlike]

I follow the Otonomy stock price and just read they reported a loss and missed revenue targets. I wouldn't buy this stock at this point.

Cheers for the update @attheedgeofscience. I will take a proper look at the info you provided later.

 

[Paulmanlike]

Just wondering... Is Otonomy targeting chronic tinnitus? Or just acute? I'm a bit baffled why they would think it would work for chronic tinnitus due to the central gain theory, like the brain turning up the volume.

 

[FGG]

Just wondering... Is Otonomy targeting chronic tinnitus? Or just acute? I'm a bit baffled why they would think it would work for chronic tinnitus due to the central gain theory, like the brain turning up the volume.

I think Oto-313 is for acute. Oto-413 would help "hidden hearing loss" which might help tinnitus in these cases once hearing is improved.

 

[Paulmanlike]

I think Oto-313 is for acute. Oto-413 would help "hidden hearing loss" which might help tinnitus in these cases once hearing is improved.

There are 2 reasons why I am doubting it is only for acute tinnitus:

- The proposed market figures would indicate they are targeting both
- No mention of a timeframe to how long you've had tinnitus in the inclusion criteria

That's pure speculation though, Tinnitus Talk needs a Q&A with Otonomy and their pipeline at some point!

 

[Frédéric]

I chose the most recent thread about Otonomy to post this link. It is written by two full-time employees of Otonomy. This article is quite interesting since it recalls a lot of clinical trials and their results.

Local Drug Delivery for the Treatment of Neurotology Disorders
Fabrice Piu and Kathie M. Bishop
Otonomy Inc., San Diego, CA, United States

https://www.frontiersin.org/articles/10.3389/fncel.2019.00238/full

 

[JohnAdams]

Why does all this stuff take so long?

 

[JohnAdams]

There are multiple members on this site that have had this BDNF treatment but they are keeping quiet about it.

 

[JohnAdams]

Is OTO-413 and FX-322 trying to do the same thing?

No.

 

[FGG]

There are multiple members on this site that have had this BDNF treatment but they are keeping quiet about it.

Really? Where did they get it? This is the one I'm most holding out hope for to hear music again. If anyone could message me with even vague hopeful information I'd be forever grateful.

 

[JohnAdams]

Really? Where did they get it? This is the one I'm most holding out hope for to hear music again. If anyone could message me with even vague hopeful information I'd be forever grateful.

All I can say is that there are multiple treatments sitting on shelves out there that can be helping us but the system is moving too slow.

None of this stuff is overly complicated. Another substance is NT-3. Some of us have actually done research and sought out physicians willing to experiment on us in the pursuit of healing. I'm not afraid to say this. People are doing stuff. The mainstream paradigm is slow and stupid.

 

[Daniel Lion]

Really? Where did they get it? This is the one I'm most holding out hope for to hear music again. If anyone could message me with even vague hopeful information I'd be forever grateful.

Same...

How you keeping FGG? Hope you're well.

 

[FGG]

Same...

How you keeping FGG? Hope you're well.

Not well honestly. In addition to hearing loss, tinnitus (started Feb 1st) and vestibular hypofunction (started last fall) my husband is initiating divorce because I'm a "dependent and not a wife anymore" .

He says I'm narcissistic because it's all about me and my suffering now so I'm profoundly lonely and my coping mechanism (music) is out if my reach. This probably belongs more on the support forum than research but I'm here all day every day hoping for miracles like many of you.

Thanks for asking. Sorry for that depressing vent.

 

[d'Wooluf]

my coping mechanism (music) is out if my reach.

Hey @FGG. I don't know anything about what specific issues are keeping you from enjoying music. In my case, I have a standard ski-slope loss that is pretty severe and pretty much killed my enjoyment of music.

I recently bought a set of Nuraphone headphones. They personalise your hearing experience by testing otoacoustic emissions from your cochlea. Four of us at the hearing loss forum I visit have tried them. Three of us love them, one not.

Having said that, they are not actually designed for people with hearing loss. They are not cheap, but there is a 30 day trial and a subscription option. If you choose to buy there are 20% off referral codes available. I have no connection with the company.

Your husband sounds like a pos, btw. Best wishes.

 

[FGG]

Hey @FGG. I don't know anything about what specific issues are keeping you from enjoying music. In my case, I have a standard ski-slope loss that is pretty severe and pretty much killed my enjoyment of music.

I recently bought a set of Nuraphone headphones. They personalise your hearing experience by testing otoacoustic emissions from your cochlea. Four of us at the hearing loss forum I visit have tried them. Three of us love them, one not.

Having said that, they are not actually designed for people with hearing loss. They are not cheap, but there is a 30 day trial and a subscription option. If you choose to buy there are 20% off referral codes available. I have no connection with the company.

Your husband sounds like a pos, btw. Best wishes.

I will look into these, thank you! I have no idea if they could help but it's worth a try. If I get them I will definitely report back!

On audiogram, I have mild low frequency hearing loss (250 Hz and lower) and moderate to severe high frequency hearing loss starting around 11000 Hz but all frequencies are severely distorted and I have difficulty hearing in noise.

My hearing loss seems to be a combined hair cell death *and* diffuse severe bilateral synaptopathy, the latter being what has destroyed music for me.

Mine is a weird case, I have secondary hydrops (like Meniere's but with a known cause) from late stage Lyme disease (causing the dizziness/vertigo) but the high dose antibiotics I was on were severely ototoxic. My doctor put me on 1000mg of Azithromycin every other day for 6 weeks. On my final week, I suddenly instantaneously and dramatically lost my normal hearing in both ears to the point that all sounds are very distorted now.

Azithromycin ototoxicity is rare and usually reversible but no subsequent doctor anywhere could find anywhere in the literature where anyone ever had been given a dose as high as i was on (I wish I hadn't so blindly trusted that doctor, especially because I know better). I may be an n=1 case .

It's now been over 4 months with *zero* improvement. Per the specialist, mine is extraordinarily unlikely to improve at this point.

A year ago, I was healthy, worked full time as a veterinarian and was planning to have a family with my husband. People have no idea how much your inner ears can ruin your life.

 

[attheedgeofscience]

People have no idea how much your inner ears can ruin your life.

Indeed.

 

[FGG]

Off of their website, here is the pdf of the presentation Otonomy have at a biotech conference yesterday:

http://investors.otonomy.com/static-files/edcfad7b-22eb-4572-9223-d0960dd7a434

 

[Clint Azzopardi]

So OTO-313 reduces THI by only 10 points? What the heck!

My THI goes down by more than 10 points after I go for a run and a good night sleep!!!! Not to mention that Lenire reduces THI more, from what I can vaguely remember.

 

[FGG]

So OTO-313 reduces THI by only 10 points? What the heck!

My THI goes down by more than 10 points after I go for a run and a good night sleep!!!! Not to mention that Lenire reduces THI more, from what I can vaguely remember.

The pilot study only had 50 people, though. The larger study is underway now.

OTO-413 has way more potential anyway imo.

 

[patorjk]

There are multiple members on this site that have had this BDNF treatment but they are keeping quiet about it.

Are these people who did it through one of Otonomy's internal trials? Or something else?