Otonomy Q1 2019 Financial Results & Business Update

So OTO-313 has to be administered over and over again?

 

After reading this, I'm confused why Otonomy is using BDNF instead of NT-3. Anyone have thoughts on this?


https://www.termedia.pl/Hearing-reg...esent-and-future-approaches,19,36991,1,1.html

 

Super quick read... and I consider you the genius. I will read again. After a super quick scan, because I need to get my kids from school, sounds like BDNF is crucial in the embriotic stage and early development. NT-3 sounds like the shit we need. Again, 5 minute scan from a certified lunatic, but that was my impression.

What do you think FGG, you're easily one of the brightest scientific minds on this forum.

What are your thoughts?

Daniel

 

My impression is exactly yours. The paper seems to imply that BDNF helps hair cells early in development but NT-3 is used (the crucial, limiting substance) to regenerate them in the adult. I wasn't aware that there was even limited regeneration ability in the adult that reduces with age but seems implied if I'm understanding the paper correctly.

My hope is that the researchers at Otonomy knew this about BDNF but maybe a high enough concentration of it can induce synaptic proliferation regardless of age. I was trying to figure out when this information about BDNF in development was obtained because if it was *after* Otonomy started their pre-clinical trials, I would be worried they bet on the wrong horse.

I might be reading too much into this, though, because my anxiety is through the roof lately.

 

Okay, found the reference to a study from 2014 about BDNF and NT-3. Looks like Liberman was one of the authors.

I had written to him (Liberman) months ago and explained I had widespread synapathy and inner hair cell damage (and outer hair damage at higher frequencies) with resultant tinnitus and marked hearing distortion.

I asked him (Liberman) if he could give me any kind of hopeful statement since I was devastated about losing my career, marriage and music. He told me that he can't obviously guarentee anything but that Frequency, Otonomy and Decibel all had good ideas about hearing loss, hidden hearing loss and tinnitus and he felt optimistic at least one of them would have a positive trial within 5 years.

FWIW, I wrote to about 10 researchers and he was the only one who responded. He didn't say much (as expected, he must be extraordinarily busy) but he seemed genuine and empathetic by his tone.

I now see an otologist the Hough Ear Institute since my vestibular case is so complex and asked him if he shares Dr. Liberman's optimism for hearing regeneration and he said that he did.

I miss music so much. My favorite band was Magnolia Electric Company and they had a song called "Hope Dies Last". That's where i am right now but I am holding on to these studies.

 

So sorry for your losses but you still have hope! I've been hanging on through many spikes. You have a family on Tinnitus Talk and your contributions are enormous. Research is light years beyond 10 years ago. I hope for a cure for hearing loss but I'd forgo getting my hearing back just to lower or stop the tinnitus.

@FGG you are a shining star with me

 

We should all regard that timeframe as unacceptable.

 

Thanks for your feedback, very enlightening. And hats off to Liberman for getting back to you, Steven Heller at Stanford took some time out to write to me as well. These guys are scientists, tend to be pretty cool, and caring people. 5 years is awesome for my own optimistic projections.

We have to accept we won’t be cured, but our pain and quality of life may improve. Thanks for getting back FGG, you're awesome. Stay strong, eat well, do saunas and relaxation stuff and know you're a star.

See you around the block, take good care,

Daniel

 

Are you saying you don't think our tinnitus would be cured only reduced? Or that our hearing loss would only reverse so much or both?

My tinnitus is only moderate (most of the time) so I would settle for enough hearing improvement to hear music again even if I was saddled with ringing my whole life. Music is so tied to how I experience life and remember things that I can't imagine spending the next 40 years on this blue dot without it.

I just wish there was any kind of concrete answer we could get even if it was with a nebulous timeline.

 

Thanks @FGG. I’m concerned about the OTO-313, the thi reduction of 10 points. I’m going through a horrible phase and that drug is my only hope to be fully functional again. What are your views?

 

The big question for me on Oto-313 is if it is useful for chronic tinnitus. I think Oto-413 will probably be more useful. All speculation though.

 

Let’s hope... Seriously all we need is one measly treatment to give a slight improvement.

 

If it works, well then yeah. It looks to me like you'd have to go get a new shot of this stuff every few weeks.

 

Otonomy has increased their clinical trial locations and are still recruiting. A good sign for efficacy? Check out the newly added centers, there might be one in your area if you are interested.


Contacts
Contact: Clinical Study Manager otonomyclinicaltrials@otonomy.com

United States, Colorado
Colorado ENT and Allergy Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Deborah Bothwell 719-867-7810 dbothwell@coloradoent.com

United States, Illinois
ChicagoENT Recruiting
Chicago, Illinois, United States, 60657
Contact: Ninos J Joseph 773-289-1823 njoseph@chicagoent.com

United States, Kentucky
Advanced ENT and Allergy Recruiting
Louisville, Kentucky, United States, 40207
Contact: Ellie Fridell 502-213-3858 ext 1185 Efridell@advancedentandallergy.com

United States, Louisiana
Tandem Clinical Research, LLC Recruiting
Marrero, Louisiana, United States, 70072
Contact: Tammy Johnson 504-934-8424 tjohnson@tandemclinicalresearch.com

United States, New York
Northwell Health at ENT and Allergy Associates Recruiting
White Plains, New York, United States, 10605

United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Sherry Fredenberg 704-295-3389 sfredenberg@ceenta.com
Piedmont Ear, Nose, and Throat Associates Recruiting
Winston-Salem, North Carolina, United States, 27103

United States, Texas
Worldwide Clinical Trials Recruiting
San Antonio, Texas, United States, 78217
Contact: Andrea Velasquez andrea.velasquez@worldwide.com

Sponsors and Collaborators
Otonomy, Inc.

https://clinicaltrials.gov/ct2/show/NCT03918109?type=Intr&cond=Tinnitus&phase=012345&lupd_s=07/06/2019&lupd_d=14

 

Thanks, I've applied to my local one 2 weeks back. No response. I'll send them all a message then, I'm willing to travel. Anything for a slight reduction.

 

Hm, interesting. I live in California but could travel to the Colorado or Texas location. I’m in the process of setting up a stem cell appointment and I wonder if that would exclude me. I’ll call today and see.

 

You have to have Tinnitus for less than 6 months for this trial.

 

Did one of the trial operators tell you this? I don’t see duration of tinnitus mentioned in the exclusion criteria.

 

Susan shore device you have to reside within 100 miles of Ann Arbor Michigan. And then qualify for their criteria. CGF 166 or whatever it’s called is no longer recruiting. I know this from reaching out to all of them.

 

Yes, and If I could figure out how to copy from my email and throw it in hear I would. I’m telling you 100% this is the case of my reaching out. Don’t let it deter you though the more reach out the more they know if it’s interest and maybe things are modified.

 

Yep just got off the phone with Deborah from the Colorado trial. They want people with no prior history of tinnitus, so it looks like another wait and see scenario.

I wonder if their goal is to see if it works in acute cases and then expand the inclusion criteria for chronic during the next phase.

One thing she did note is that you have to be at the location several times over the course of 6 months, so I think they prefer you to at least be within state.

 

They have all these trials, but either the criteria is too strict or you have to quit your job, move, or be retired to be available. I can’t get in one where I can go have it done or take a device home. Not good. Meanwhile if you live in Ireland you got a chance. Us in the U.S. have to sit on our *ss and wait.

 

So they only want acute cases? Or are they inducing tinnitus on people without it to test the drug?

The latter sounds like madness.

 

Lol no my bad. I meant they only want people who have never had tinnitus before and that this is their first time experiencing it - so yeah acute cases only atm. They’re not giving anyone T (well at least not intentionally).

 

Haha okay. Well I would give it a shot except I'm also in California.

 

Oh and in case you are interested, UC Irvine is also doing a clinical trial of electrical stimulation either by needle or cochlear promontory stimulation for people with normal hearing. The eligibility is having tinnitus for at least 6 months and be able to go back for regular visits.

 

Is there a thread on this? I couldn’t fine one. Might make one to track progress. It sounds like a variation of what Neuromod and Susan Shore are doing, but with the focus being on electrical pulses to the cochlea and not the trigeminal nerve.

 

Exactly. From what I was reading, they will be doing acoustics too. I don't think there is one, go ahead if you'd like.

 

Yes I believe they stick an electrode in and see what happens. I’ve mentioned this before, Neuromod, Shore just sends an electrical signal up somewhere. I believe they’re just mimicking an internal CI which is only 70% probable to at least suppress tinnitus. Honestly I don’t think any of them know what’s going on. I really wish somebody could figure out what it is for certain to attack the root of the problem. But I guess it’s good they are at least trying.

 

Well, the researchers at UCI are very transparent about how little they know, and that this is more of an exploratory trial. If you read their brief a lot of verbiage surrounds trying to figure out what will work best. The basis of this trial is a 2003 study quoted from their detail page here:

“Most recently in a preliminary study in 2003, Rubinstein et al, used a needle electrode passed through the ear drum to suppress tinnitus. The authors used a high pulse rate of 4,800 pulse-per- second (pps) for their electrical stimulation. They found that 5 of 11 (45%) subjects with electrical stimulation of the inner ear through the ear drum using a needle electrode showed substantial or complete tinnitus suppression with either no perception or only a transient perception of the stimulus. Three (27%) showed tinnitus suppression with the perception of the stimulus and three showed no suppression of the tinnitus.”

But we can discuss more on the other thread.