Otonomy OTO-413 — Treatment of Hidden Hearing Loss

Discussion in 'Research News' started by Michael Larsen, Jan 9, 2018.

    1. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      Nothing to worry about. Tax-related.
       
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    2. dd314

      dd314 Member

      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Acoustic Trauma + stress?
      That's assuming it isn't excitation of the nerve fiber, which comprises a nontrivial subset of tinnitus cases (e.g., inflammation, hydrops) and it's a way easier problem to fix. I have some cautious optimism about OTO-313 and I don't believe most cases of tinnitus are a matter of centralization. Remember this, brain scans are correlates and nothing else. Doesn't matter if it's EEG, fMRI, fNIRS etc. Don't get me wrong, I believe certain etiologies are a matter of centralization, but technically they can't prove it without ablation of the fiber.
       
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    3. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
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      Clubbing
      Dang. I can't help it, I'm getting as excited for the results as I was last year for FX-322.
       
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    4. ThomasF
      Creative

      ThomasF Member

      Location:
      Florida
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Probably loud music
      That's a good thing. Hope is important for finding a treatment or cure.
       
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    5. Bambam0
      Cool

      Bambam0 Member Podcast Patron Benefactor

      Tinnitus Since:
      2/2018
      Cause of Tinnitus:
      Drums
      When does "early" Q2 become "mid"?

      Asking for a friend...
       
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    6. Geatly

      Geatly Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Noise induced, by jackhammering into concrete on constructio
      Early Q2 can be until end of April, so it's still early Q2.
       
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    7. Exit

      Exit Member Benefactor Hall of Fame

      Tinnitus Since:
      01/2020
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      Noise
      Mid-May is my hope at the latest for any information worth reading.
       
    8. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      I was so happy to read about the positive results. Then I woke up.
       
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    9. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
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      Unknown/Stress
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    10. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      • 40% (8 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 20% (2 out of 10) for placebo.

      • 15% (3 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement by two or more different SIN tests at both Days 57 and 85 versus 0% (0 of 10) for placebo.

      • For the Words-in-Noise test that has been well-established and validated in hearing loss patients, 40% (6 of 15 with evaluable tests) OTO-413 subjects demonstrated a clinically-meaningful improvement at both Days 57 and 85 versus 0% (0 of 9 with evaluable tests) for placebo.

      • Most of the patients enrolled in this trial also had moderate-to-severe high-frequency hearing loss measured with standard audiometric testing. The responder rate for OTO-413 was favorable in this subset as well with 41% (7 of 17) OTO-413 subjects demonstrating a clinically-meaningful improvement in at least one SIN test at both Days 57 and 85 compared to 13% (1 of 8) placebo subjects.

      • The PGIC demonstrated a treatment benefit with 50% (10 of 20) OTO-413 subjects reporting an improvement from baseline at both Days 57 and 85 compared to only 10% (1 of 10) for placebo.

      • Treatment with OTO-413 was well tolerated. There were no serious adverse events and no discontinued patients due to an adverse event (AE). 32% of OTO-413 and 46% of placebo subjects reported an AE, most of which were mild.
      Based on these positive results, Otonomy intends to initiate a full dose-ranging Phase 2 trial in hearing loss patients by the end of 2022. This trial will also incorporate learnings from the ongoing higher dose evaluations that are assessing the tolerability and treatment activity of two higher doses of OTO-413: 0.75 mg and 1.50 mg, which is five times the dose evaluated in the Phase 2a trial. Results from the higher dose evaluation are expected in the second half of 2022.
       
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    11. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
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      Clubbing
      YEAAAAAAAAH. Next up: OTO-313 :cool:
       
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    12. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
    13. Geatly

      Geatly Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Noise induced, by jackhammering into concrete on constructio
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    14. dbeats

      dbeats Member

      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Loud noise
      Fantastic news!
       
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    15. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Don't expect miracles from first generation hearing loss therapies.
       
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    16. dbeats

      dbeats Member

      Tinnitus Since:
      2020
      Cause of Tinnitus:
      Loud noise
      For any illness or disorder, there will always be heterogeneities in what's causing it.
       
    17. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      Indeed and remember: even a subset of hearing loss sufferers translates to millions of people that can be helped worldwide!
       
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    18. LAnative
      Fine

      LAnative Member Benefactor

      Location:
      California
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      06/2018
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      Gunshot
      IT'S WORKING, PEOPLE!

      ALL ABOARD THE HYPE TRAIN!

      CHOOO CHOOOO.
       
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    19. patorjk
      No Mood

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      This larger, extended Phase 1 trial (at some point renamed a Phase 2a trial) was just to confirm that the drug works, and from this data it looks like it does. I was starting to get worried but this data - while not as good as the original set - is still good and it bodes well for the 5x dosage trial that's going on right now. I've long felt Otonomy has underdosed their drugs (it's one of the reasons I think Otividex failed - a drug that really should have worked), so the 5x trial should show us what this drug can really do.

      I found this exciting (PGIC = Patients' Global Impression of Change):
      Assuming the 40% who saw an improvement on a test are a subgroup of that group, it means people are really noticing a real world effect from the drug.
       
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    20. Bambam0
      Cool

      Bambam0 Member Podcast Patron Benefactor

      Tinnitus Since:
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      Great news y'all! :beeranimation:

      Very excited for higher dose results!
       
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    21. Eliot Martin

      Eliot Martin Member

      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      Medications
      What if FX-345 shows improvements of at least 20 dB in audiograms?
       
    22. JPGL
      Frustrated

      JPGL Member Benefactor

      Location:
      Spain
      Tinnitus Since:
      10/2015
      Cause of Tinnitus:
      Hearing loss? Noise? Stress? Unknown
      Thank you my God and thank you Otonomy. Keep up the good work.
       
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    23. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      I was wondering why investors don't seem to care about the results. So I compared them with the Phase 1/2 results and this does curb my enthusiasm a bit.

      40% vs 67% OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85.

      15% vs 33% OTO-413 subjects demonstrated a clinically-meaningful improvement by two or more different SIN tests at both Days 57 and 85.

      Still clearly better than the placebo group though.
       
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    24. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Absolutely, but OTO-413 was one of the treatments with most potential. A 40% success rate is great obviously but I guess I was hoping for more. Intratympanic injections caused worsening for some people - I'm not too keen on a 40/60 treatment with possible adverse affects on the tinnitus.

      Too bad there are no anecdotes provided on tinnitus. You'd expect at least some of them have tinnitus.

      Either way let's stay positive, assuming that the high dose will push this well over 50%!
       
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    25. LAnative
      Fine

      LAnative Member Benefactor

      Location:
      California
      Tinnitus Since:
      06/2018
      Cause of Tinnitus:
      Gunshot
      Perhaps there are very subtle differences between the groups of hearing loss. For example hearing loss from a shotgun blast of 180 dB might have different kind of damage compared to a decade of being a musician. This may explain why some respond and others don't. Different kinds of damage.

      Either way, it looks like we have something that works for at least a subset of the population.
       
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    26. patorjk
      No Mood

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      Yep, it seems to have caused some confusion among investors. People expected the results to be more in-line with the previous ones, yet they weren't bad and still showed the drug still worked over a larger sample size. I also think the placebo effect showing its head has spooked some people a little. It seems like a 10-20% response rate for placebo patients is going to be normal for hearing studies (which is what we've seen in the FX-322 trials). However, I think the two time point threshold they've setup is protecting them somewhat. In the previous trial they also had placebo responders, but they only responded at one time point:

      sin_test.png

      This time 2 of 10 placebo patients responded, but only 1 of them reported a positive PGIC, which means they scored higher twice, but didn't believe they got any real improvement from the drug (so maybe their initial test was just low).

      I don't think they reported the PGIC score last time, but the fact that it's 50% for the OTO-413 group is really good. It means patients feel the drug working.
       
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    27. Champ
      Woot

      Champ Member Benefactor

      Location:
      Boston, MA
      Tinnitus Since:
      01/2013
      Cause of Tinnitus:
      Acoustic trauma from headphones
      I suspect these higher dose trials are going to have very good results for both Otonomy and Frequency Therapeutics based on how their original formulations performed. Now that we know they're generally safe, it's time to maximize their effect!
       
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    28. Exit

      Exit Member Benefactor Hall of Fame

      Tinnitus Since:
      01/2020
      Cause of Tinnitus:
      Noise
      Agree! Still a long way to go and investors know that.

      Might be a slow uptick during the next days if the markets are in green.
       
    29. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Stock is up by 11% so investors are happy as they see potential here. If they are happy, we should be too!
       
    30. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      Based on the heterogeneity of hearing loss, 40% to 50% of subjects improving is spectacular considering improving hearing has never been done before and not everyone that has hearing loss is guaranteed to have synaptic damage that can benefit from OTO-413.
       
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