Audion Therapeutics Trial

Discussion in 'Research News' started by Aaron123, May 20, 2017.

    1. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      It looks like the 4/30 date was on their clinical trials page. As I understand this is usually an estimate not a hard and fast rule.
       
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    2. patorjk

      patorjk Member

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      I feel like if they had really good results they'd want to get that info out there quick so that they could start the process of bringing the drug to the market. However, I can only speculate. Frequency releasing a statement on April 30th makes me wonder if they were worried about Audion, or if they had inside info that Audion was about to release something big.

      I emailed Audion's CEO about the study results. If I hear anything back I'll post it here.
       
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    3. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      If anyone is up for it might be best to ring that number on the previous page that I posted rather than email.

      Audion Therapeutics
      Rolf Jan Rutten
      CEO
      +31646767255

      I would do it but can’t tolerate phone calls.
       
    4. Tweedleman
      Depressed

      Tweedleman Member Benefactor

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      I wondered where that date came from. I'm chomping at the bit for ANY positive news about regenerative medicine. Even if it's all still years away, any kind of affirmation that cochlear regeneration is coming gives me so much peace of mind. Bummed these guys have been so quiet, even though their approach isn't the most favorable.
       
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    5. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      Here’s the clinical trials page for Audion Therapeutics:

      http://www.isrctn.com/ISRCTN59733689

      They stated an estimated date of 30th April 2020 for phase 2 results but I guess that didn’t happen lol.

      Maybe they will prove us wrong and release the results soon.
       
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    6. Juan

      Juan Member

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      There is a "contact us" button here as well:

      https://www.regainyourhearing.eu/
       
    7. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      I saw that but it takes ages for them to reply. That’s why I posted the phone number so someone could ring and ask straight away. I think that number is from the Netherlands so maybe someone from there could text or ring.

      @Hazel since you are from there, any chance you could text or ring that number to find out when they are releasing Phase 2 clinical trial results?
       
    8. serendipity1996

      serendipity1996 Member

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      I've just sent them an email as well - not expecting much but maybe we'll hear something soon.
       
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    9. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      I emailed Action on Hearing Loss UK to see if they know anything since they posted a research news article back when Phase 1 results were released and replying to people comments which made me think they were in some partnership with Audion Therapeutics in terms of information but sadly they don’t know anything. They told me to go on Audion Therapeutics website to check out the latest news.
       
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    10. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      I still wonder why Frequency Therapeutics have been more upfront about FX-322 compared to Audion Therapeutics. If they talked more about where they are at in the trials maybe it would have been just as popular as FX-322 and they could have had more funding from other companies unless Audion Therapeutics could only have one company, Eli Lilly, funding them.

      I really hope they contact back and say why it’s taking them so long to release the clinical trial results. They were on Phase 2 and they might not even need Phase 3 to release the drug since there are no alternatives.
       
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    11. FGG
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      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      What is the European process and what constitutes their trial phases?
       
    12. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      1-s2.0-S2452302X16300638-gr1.jpg
      I found this online.
      https://www.sciencedirect.com/science/article/pii/S2452302X16300638

      I’m still not sure what their process is compared to the USA FDA but from the diagram looks similar. Didn’t someone say the clinical trials done in Europe are less strict compared to the USA so the drug can get released faster?

      Looking at the emergency orphan usage it says less than 200,000 suffering from that condition in the US compared to 50,000 in Europe. It might not be possible to get expanded use for tinnitus but for hyperacusis it’s a definite yes.
       
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    13. Mentos

      Mentos Member Benefactor

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      Can you share how did you obtain his phone number? I am willing to call him but I want to be prepared in case he asks me about how I got the number. Is it publicly available?
       
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    14. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      Yes if you go on Audion Therapeutics website and on to the recent news about the clinical trials it has the CEO's name and number at the bottom. That’s how I got that information.

      Here’s the link:
      http://www.audiontherapeutics.com/2...-in-patients-with-sensorineural-hearing-loss/

      I really appreciate you doing this. I really wanted to be the one to do it but I can’t handle phone calls. Thanks man.
       
    15. FGG
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      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      You can get expanded use in drugs that aren't "orphan drugs" I believe so those numbers wouldn't be relevant for non orphan drugs.
       
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    16. Mentos

      Mentos Member Benefactor

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      I couldn't reach him for a whole day, I left a message on his voicemail.
       
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    17. Rubenslash

      Rubenslash Member

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      Let's be patient, 30th of April is an estimated timing. I would be worried if they didn't release it by end of July, not 6 days after an indicative timeline.
       
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    18. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      Initial release date was 30th January 2020 but they changed it to 30th April 2020. Wondering why it would take so long to review the results.
       
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    19. Croaker
      Torn

      Croaker Member

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      because it probably didn't go well.
      The trials didn’t go well, clearly. It’s a shame, I never planned to receive this treatment but it would have shed light on the relationship between cochlear regeneration and tinnitus/hyperacusis.
       
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    20. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      We don’t know if that’s why the results were delayed. I still believe the Audion anecdote about being able to rejoin the band and go on tour due to their tinnitus and hyperacusis reducing.

      They could really have a winner here. Let’s just wait and see. @Mentos has contacted the CEO but it went to voicemail. The CEO may ring or text him back with news.
       
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    21. FGG
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      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      I really doubt Audion would release trial news to a rando before they do a press release but, who knows? Weird things happen sometime.
       
    22. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      I don’t believe they will either because I emailed them earlier this year and they couldn’t tell me anything. But yea weird things happen and maybe @Mentos might actually receive some news or a date when the clinical trial results will actually be released. Who knows but I’m grateful @Mentos decided to call the CEO because it seems like no one else was going to.
       
    23. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      If it turns out Audion Therapeutics are delaying Phase 2 clinical trial results because it didn’t meet the endpoints then I’m guessing Frequency Therapeutics might be the same as well :’(
       
    24. FGG
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      Why? One has nothing to do with the other.

      Are you aware that Audion's and Frequency's methods of regeneration are very different?
       
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    25. FGG
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    26. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      I know that. I just don’t want hope to die if these 2 drugs fail even though they seem to be the most promising drug to work for us.
       
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    27. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

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      But you are making it sound like Audion's success or failure has anything to do with Frequency's potential and it literally has nothing to do with it.
       
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    28. Lucifer

      Lucifer Member Podcast Patron Benefactor

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      For those of you who emailed the CEO weeks ago, have you received a reply yet?

      If not this is pretty poor for a CEO, it should not take months for a small reply stating when they will release clinical trial information or not.

      I understand with coronavirus there will be a delay but the trials have finished in December and they should have had plenty of time to review the results.

      I hope they are still continuing with trials and not sitting at home and watching Netflix and chilling.

      I just really want to know if the results were positive and when a Phase 3 clinical trials will commenced.
       
    29. xyz

      xyz Member

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      Probably no one received a reply so far. I mean at least they could reply with something like "Sorry our results are delayed. We will keep you posted."
       
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    30. patorjk

      patorjk Member

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      If I hear anything back from them I'll post here. My email is now 10 days old and there's been no response. Here's what I wrote:

       
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