Otonomy Q1 2019 Financial Results & Business Update

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"...)

 

Good to hear!

 

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?

 

Otonomy's stock is doing



so investors' confidence must be low.

 

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.

 

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...

 

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!

 

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?

 

Wohoooo OTO-413 should fix me then

 

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.

 

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.

 

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!