Otonomy Q1 2019 Financial Results & Business Update

Discussion in 'Research News' started by attheedgeofscience, May 6, 2019.

    1. JohnAdams
      Greedy

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      So OTO-313 has to be administered over and over again?
       
    2. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      • Good Question Good Question x 2
    3. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      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
       
      • Good Question Good Question x 1
    4. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
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    5. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
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    6. Ken219
      Frustrated

      Ken219 Member

      Location:
      New York Area
      Tinnitus Since:
      Summer of 1990
      Cause of Tinnitus:
      Noise exposure?
      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 :huganimation:
       
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    7. JohnAdams
      Greedy

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      We should all regard that timeframe as unacceptable.
       
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    8. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      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
       
      • Agree Agree x 1
    9. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
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    10. Candy

      Candy Member Benefactor Advocate

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Unidentified
      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?
       
    11. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      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.
       
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    12. Candy

      Candy Member Benefactor Advocate

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Unidentified
      Let’s hope... Seriously all we need is one measly treatment to give a slight improvement.
       
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    13. JohnAdams
      Greedy

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Vatican
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      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.
       
    14. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      CA
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      U.S. Army/Field Artillery Veteran
      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

       
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    15. AVIYT
      Wishful

      AVIYT Member Benefactor

      Tinnitus Since:
      January 2019
      Cause of Tinnitus:
      Pregabalin
      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.
       
    16. HootOwl

      HootOwl Member Benefactor

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      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.
       
    17. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      You have to have Tinnitus for less than 6 months for this trial.
       
    18. HootOwl

      HootOwl Member Benefactor

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      Did one of the trial operators tell you this? I don’t see duration of tinnitus mentioned in the exclusion criteria.
       
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    19. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      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.
       
    20. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      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.
       
    21. HootOwl

      HootOwl Member Benefactor

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      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.
       
    22. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      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.
       
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    23. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      CA
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      U.S. Army/Field Artillery Veteran
      So they only want acute cases? Or are they inducing tinnitus on people without it to test the drug?

      The latter sounds like madness.
       
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    24. HootOwl

      HootOwl Member Benefactor

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      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).
       
    25. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      CA
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      U.S. Army/Field Artillery Veteran
      Haha okay. Well I would give it a shot except I'm also in California.
       
    26. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      CA
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      U.S. Army/Field Artillery Veteran
      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.
       
    27. HootOwl

      HootOwl Member Benefactor

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      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.
       
    28. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      CA
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      U.S. Army/Field Artillery Veteran
      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.
       
    29. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      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.
       
    30. HootOwl

      HootOwl Member Benefactor

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      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.
       
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