Reformulated Retigabine (Trobalt): BHV-7000, a Kv7.2 Modulator by Biohaven (Pfizer)

Discussion in 'Research News' started by InNeedOfHelp, Nov 14, 2022.

    1. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      In the last Xenon Pharmaceuticals conference call they named BHV-7000 a direct competitor for XEN1101.

      BHV-7000 is a reformulated, more potent version of Trobalt/Retigabine.

      Pfizer acquired Biohaven which brings big pharma to this development space.

      BHV-7000 is currently in Phase 1 but is expecting to launch a Phase 2 and Phase 3 in parallel next year to launch simultaneously with Xenon Pharmaceuticals' XEN1101. Seems like a first to market competition. Xenon Pharmaceuticals mentioned in their call last week that the Phase 3 will be hopefully shorter than the Phase 2 trial that lasted 2.5 years.

      Biohaven actually has a compassionate use program which Xenon Pharmaceuticals does not have.

      Biohaven Sets New Course Following Pfizer Acquisition:
      Vlad Coric charts course for new Biohaven with neuroscience push and Big Pharma vets on board:
       
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    2. CRGC
      No Mood

      CRGC Member

      Location:
      Montreal
      Tinnitus Since:
      06/2022
      Cause of Tinnitus:
      SNRI/Noise
      Very interesting and exciting news, thanks for this!

      The press release states that "Biohaven’s primary focus will be developing treatments for neurological and rare disorders including epilepsy, pain and mood disorders, obsessive-compulsive disorder, spinocerebellar ataxia and spinal muscular atrophy."

      I wonder if tinnitus is on their radar?
       
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    3. Nick47

      Nick47 Member Benefactor Hall of Fame

      Location:
      UK
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      2015
      Cause of Tinnitus:
      Viral/noise
      I wonder if an email to the CEO highlighting the success of Trobalt on tinnitus would increase the likelihood of them conducting a small trial for tinnitus alongside their other indications.
       
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    4. AnthonyMcDonald
      Confused

      AnthonyMcDonald Member Hall of Fame

      Location:
      USA
      Tinnitus Since:
      06/2021
      Cause of Tinnitus:
      Noise induced
      Good. One thing I was afraid of was Xenon Pharmaceuticals jacking up their prices due to having total market domination. This is the biggest, in my opinion, most scientifically-backed "cure" that we have coming our way.

      They definitely know about tinnitus. Pfizer loves profits. We are definitely on their radar.
       
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    5. Hottopic29

      Hottopic29 Member Benefactor

      Location:
      Niagara falls
      Tinnitus Since:
      11/2013
      Cause of Tinnitus:
      Zithromycin acoustic trauma 2022
      They have a compassionate use program for BHV-7000. They are studying it for pain. I think a lot of people with noxacusis might be able to access it through the compassionate use program.
       
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    6. AUTHOR
      AUTHOR
      InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Before it was transformed into BHV-7000 by Biohaven, it was named KB-3061 from Knopp Biosciences: Knopp’s preclinical Kv7 platform is directed to small molecule treatments for neonatal epileptic encephalopathy, other rare epilepsies, tinnitus, and neuropathic pain

      They are well aware of the tinnitus potential. They are all awaiting an objective tinnitus test in my opinion before trialing.
       
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    7. Nick47

      Nick47 Member Benefactor Hall of Fame

      Location:
      UK
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      2015
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      Bigger and more scientifically backed than Dr. Susan Shore and colleagues?
       
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    8. Stayinghopeful
      Procrastinating

      Stayinghopeful Member Benefactor

      Location:
      NSW, Australia
      Tinnitus Since:
      06/2022
      Cause of Tinnitus:
      Worsened with COVID-19 / Anesthesia
      I read they are starting with 250 million, so I'd wager so.
       
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    9. Ela Stefan

      Ela Stefan Member

      Tinnitus Since:
      11/2018
      Cause of Tinnitus:
      Ear Infection
      So BHV-7000 is in pre-clinical stage? When are the human clinical trials expected to start?
       
    10. Nick47

      Nick47 Member Benefactor Hall of Fame

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      I don't mean how much money they have, just that they have shown no interest in tinnitus. No study, no findings and no trials.

      Pfizer are even bigger but no use to us currently.
       
    11. Fightthearmy

      Fightthearmy Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      work-related
      The word "compassionate" & the word "tinnitus" = low mutual information value.
       
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    12. StoneInFocus
      Badass

      StoneInFocus Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing damage, ear infections
      Fantastic news. Let's see how its side effects compare to other potassium channel openers such as cannabidiol, XEN1101 and RL-81.
      Kv7.2/7.3 channel openers for the treatment of tinnitus are way, way more scientifically sound than Dr. Shore's Auricle device, which is basically glorified acupuncture from what I read of it (please correct me if I'm wrong). A Kv.7.2/3 channel opener has been proven to help prevent the emergence of tinnitus in mice after noise exposure.

      By the way, in the title it says that BHV-7000 is a Kv7.2 opener, but according to the website, "BHV-7000 is a potent activator of Kv7.2 [and] Kv7.3."
       
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    13. Nobody19

      Nobody19 Member Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      It is common knowledge that CEOs take business decisions based on mails by random people.
       
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    14. Pharz
      Alone

      Pharz Member Benefactor

      Tinnitus Since:
      -
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      How is this beneficial for tinnitus sufferers?

      (Please excuse my lack of knowledge in this field).
       
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    15. AnthonyMcDonald
      Confused

      AnthonyMcDonald Member Hall of Fame

      Location:
      USA
      Tinnitus Since:
      06/2021
      Cause of Tinnitus:
      Noise induced
      Dr. Susan Shore's research supports the fact of the DCN going haywire in tinnitus generation.
       
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    16. Nick47

      Nick47 Member Benefactor Hall of Fame

      Location:
      UK
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      2015
      Cause of Tinnitus:
      Viral/noise
      I think you misunderstood if you think Dr. Shore's device is glorified acupuncture. 20 years of scientific research and successful double-blind, sham-controlled trials doesn't lead to acupuncture. Best thing would be to read the thread. You give some good advice in other threads but I plead you to look into this more.

      There is nothing more than a hypothesis (although a very reasoned one based on Retigabine) that this BVH-7000 would be helpful. The animal studies look like they are tested on 'acute' conditions only.

      Might it work? Look, who knows. Deep down, given the tinnitus market, I always find it difficult to believe - if they thought it would help with tinnitus symptoms - they wouldn't be in trial for that indication.
      Yes, I see your point regarding email. I was 'shooting' from the hip.
       
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    17. StoneInFocus
      Badass

      StoneInFocus Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing damage, ear infections
      20 years of research doesn't change the fact that is is just electrical pulses that stimulate nerves (not unlike acupuncture) combined with sounds. Appears to me like an experimental treatment with little theory to back its efficacy up. Haven''t seen a single paper describing why or how that is supposed to work for tinnitus. But again I haven't really looked into it too deeply. You could be right. It's foolish to argue about this anyway. And if it works for tinnitus sufferers I'm glad for them, I would definitely try it out too but I don't think it is available in my area yet.

      EDIT:

      I want to take this back, I just haven't investigated this subject enough to say anything sensible about it. Dr. Susan Shore's method just sounds an awful lot like that treatment in South Korea, and we all know how that went down. But this thread isn't about that anyway.
       
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    18. CRGC
      No Mood

      CRGC Member

      Location:
      Montreal
      Tinnitus Since:
      06/2022
      Cause of Tinnitus:
      SNRI/Noise
      I haven't really followed the Kv7 modulator threads so apologies if this has been discussed already, but is there any possibility that these classes of drugs could help with hyperacusis?
       
    19. Hottopic29

      Hottopic29 Member Benefactor

      Location:
      Niagara falls
      Tinnitus Since:
      11/2013
      Cause of Tinnitus:
      Zithromycin acoustic trauma 2022
      Yes since it's also used for pain.
       
    20. Travis Henry
      Cynical

      Travis Henry Member

      Location:
      Dallas,TX
      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      1 Moderna Vac, Noise and stress I guess, its killing me
      Is there a chance they would prescribe BHV-7000 for compassionate use? I'd rather do this than Retigabine.
       
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    21. AnthonyMcDonald
      Confused

      AnthonyMcDonald Member Hall of Fame

      Location:
      USA
      Tinnitus Since:
      06/2021
      Cause of Tinnitus:
      Noise induced
      There have been numerous, although anecdotal reports, of complete suppression of noxacusis/loudness hyperacusis with Retigabine, which doesn't target the exact potassium channels we need and is less potent than both of these medications. I'd say there's a very good chance they will help.
      @Nick47, most people who were massively helped by Retigabine (@Danny Boy, etc) have had tinnitus for months/years before trying it. Albeit the side effects were disastrous. Based on the results of the XEN1101's side effects after the trials, I can say that the side effects aren't bad at all/minimal.
       
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    22. Ela Stefan

      Ela Stefan Member

      Tinnitus Since:
      11/2018
      Cause of Tinnitus:
      Ear Infection
      If XEN1101 and BHV-7000 are targeting Kv 7.2 and 7.3, how much of use will they be? There was a map of the auditory network posted here by you, which states that Kv3.1 channels are much more important to modulate at the inferior colliculus (IC) level.
       
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    23. Sugar_Boy
      Balanced

      Sugar_Boy Member

      Tinnitus Since:
      03-12-2020
      Cause of Tinnitus:
      neurasthenia
      When will the first phase of the clinical trial be published?
       
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    24. Christiaan
      Inspired

      Christiaan Member Podcast Patron Benefactor Hall of Fame

      Location:
      The Hague, the Netherlands
      Tinnitus Since:
      2016
      Cause of Tinnitus:
      2016: headphones, 2020: worsened thanks to Rammstein
      I've asked Biohaven if it is considering a BHV-7000 trial for people with tinnitus. This is the company's answer:
       
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    25. AnthonyMcDonald
      Confused

      AnthonyMcDonald Member Hall of Fame

      Location:
      USA
      Tinnitus Since:
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      Cause of Tinnitus:
      Noise induced
      The IC is insignificant/superficial in the generation of tinnitus compared to the DCN, at least in the research papers I have reviewed.
       
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    26. Travis Henry
      Cynical

      Travis Henry Member

      Location:
      Dallas,TX
      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      1 Moderna Vac, Noise and stress I guess, its killing me
      Is this a no? I can't get an answer from them. I need it now.

      EDIT:

      I spoke to the VP, Investor Relations at Biohaven Pharmaceuticals today. Very nice lady. I told her how much the tinnitus community is interested in BHV-7000. I'm hoping she speaks to the higher ups about trialing it for tinnitus. She said she would. I hope it at least gets out there for compassionate use for epilepsy or something. I told her I'd invest $115k just to try it now.
       
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    27. Nobody19

      Nobody19 Member Benefactor

      Tinnitus Since:
      2012
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      Clubbing
      Invest that in fundamental research instead, like Hyperacusis Research.
       
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    28. Travis Henry
      Cynical

      Travis Henry Member

      Location:
      Dallas,TX
      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      1 Moderna Vac, Noise and stress I guess, its killing me
      I've already donated to Hyperacusis Research.

      I was making up that I had $115k. I'd sell my house to get better though.

      Do you think they would already offer compassionate use for BHV-7000 for epilepsy? Or any other condition? Or is it still in the developmental phase? I wish I had asked her that.
       
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    29. StoneInFocus
      Badass

      StoneInFocus Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing damage, ear infections
      If you're that desperate, why not just give cannabidiol isolate a shot?

      For less than a hundred bucks you can get very pure powder.

      It acts on the same potassium channels and the risks are relatively well known. Just make sure to actually get CBD isolate powder, not any full spectrum oil.

      MOD EDIT: Further discussion on cannabidiol isolate should be placed in the thread @StoneInFocus linked above, thanks!
       
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    30. AUTHOR
      AUTHOR
      InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      There was a publication today about BHV-7000 on Seeking Alpha (an investor platform). They are expecting a pivotal trial (Phase 3 or Phase 2/3) to take place in H2 2023. Seems a very aggressive approach. Maybe we are lucky and their patient recruitment is also very aggressive and fast. Did anyone reach out on the compassionate use program yet? If so, I'd recommend pain with tinnitus as the reason, not tinnitus alone.
       
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