Xenon Pharmaceuticals' XEN1101 — Kv7 Potassium Channel Modulator

Discussion in 'Research News' started by jer, Mar 3, 2018.

    1. jer

      jer Member

      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      Acoustic trauma
      I am not sure if this is already posted, but anyway.

      http://epilepsy-london.org/clinical-trial-new-anti-epileptic-drug/

      I hope someone on the board is in London and able to get in this trial.

      Key Inclusion Criteria:

      Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.50 and 30.00 kg/m2

      Must agree to use effective methods of contraception, if applicable

      Able to swallow capsules

      Able to provide written, personally signed and dated ICF

      Key Exclusion Criteria:

      Any history of epileptic seizures

      Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study

      Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale

      Mental incapacity or lingual barriers precluding adequate understanding, cooperation, and compliance with the study

      No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end

      No smoking 60 days prior to dosing to study end

      No soft drugs 3 months prior to Screening and hard drugs 2 years prior to Screening
       
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    2. Danny Boy
      Cheerful

      Danny Boy Member Benefactor Hall of Fame

      Location:
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      Tinnitus Since:
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      Cause of Tinnitus:
      Ear infection
      Interesting, so there's no exclusion criteria if you have tinnitus?
       
    3. Localboy

      Localboy Member Benefactor

      Tinnitus Since:
      2010
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      hearing loss from concerts, hunting, tools, and accident
      It's epilepsy trial so no tinnitus as exclusion criteria. Phase 1 with healthy (no epilepsy or other major diseases the investigator can disqualify you at will) volunteers. You also get paid £1300 if you take part.
       
    4. AUTHOR
      AUTHOR
      jer

      jer Member

      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      Acoustic trauma
      I think it might be an excellent trial for people to partake in if they are in/near London, or are willing to travel there.

      This is what it said on the link. I am not sure if it’s not a criteria. But maybe check to see if it is or not.
       
    5. Danny Boy
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      Danny Boy Member Benefactor Hall of Fame

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      Yes, I understand that... However, I would be willing to do the trial, but honestly, it'll be beneficial if they knew the medication has potential for tinnitus. But with how scattergun trobalt was, I guess it makes it harder to tell which channel worked better for tinnitus.

      This medication it not working on (KCNQ) both KV7.2/3 , it might not work for tinnitus. I can't say for sure though. In research, the most important channels for epilepsy and tinnitus was KV7.2/3.

      Knopp biosciences are making a medication on the same target for epilepsy, KCNQ2 and said this about tinnitus "In tinnitus, we are developing potent channel-subtype activators for proof-of-concept studies in animal models."
       
    6. Tezcatlipoca
      Question it

      Tezcatlipoca Member

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    7. Kleiner

      Kleiner Member

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    8. Matchbox
      Wishful

      Matchbox Member

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    9. Gb3

      Gb3 Member

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      Which drug are we going to be interested in?
       
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    10. Matchbox
      Wishful

      Matchbox Member

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      Take your pick, there are a few K channel modulators in the pipeline from Xenon.

      There was only one (Trobalt/Retigabine), and it's a niche market which worked for a lot of tinnitus sufferers but it was super dangerous & too broad acting.

      Xenon's act on a similar mechanism with stronger binding.
       
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    11. Matchbox
      Wishful

      Matchbox Member

      Location:
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      Cause of Tinnitus:
      Noise Induced, Prednisone (drones), Barotrauma (distortions)
      Yes. Lower dosings and stronger bonds where they believe it is most likely to react means less side effects or deposition in other non target tissues.

      If it's safe for developing babies, it's safe for you.
       
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    12. Gb3

      Gb3 Member

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      When are these expected on the market?
       
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    13. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      2023 at the latest. Could be sooner if the FDA takes interest.
      It's also going to be tested for MDD, which I think means it is safe to take long term. Let's hope it doesn't give visual snow like Trobalt used to.
       
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    14. Matchbox
      Wishful

      Matchbox Member

      Location:
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      Tinnitus Since:
      08/2020
      Cause of Tinnitus:
      Noise Induced, Prednisone (drones), Barotrauma (distortions)
      Well, that might have to be a tradeoff, depends how much visual snow. Babies don't know if they get visual snow.
       
    15. Kleiner

      Kleiner Member

      Tinnitus Since:
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      XEN1101 seems to be an even better reformulation than XEN496. It targets KV7.2/3 channels and is much more selective.

      In addition, it's tested on 300 adults, it will provide more information on side effects.

      In the Phase 2 trial, subjects take one dose per day for 8 weeks. I don't know if this treatment is designed to be used for a long time.

      The drug has not yet shown its effectiveness, but it's interesting.
       
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    16. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      And Quralis's QRA-244 is even more specific and potent than XEN1101, but they're only in pre-clinical stage.
       
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    17. Lucifer

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    18. Paulmanlike

      Paulmanlike Member Benefactor Hall of Fame

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      There won't be any tinnitus data though?
       
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    19. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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    20. Alan P
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      Alan P Member

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      Can someone help break the significance down a little for a dullard over here... Trying to follow along. Seems like this is good news but can't tell.
       
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    21. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

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      The big one. Best potential in short to medium term for relief along with Dr. Shore's device. Both focus on calming over excitable potassium channel cells, which cause tinnitus in a particular area of the auditory network.
       
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    22. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor Hall of Fame

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      So Phase 2b results, if they are magically awesome, can they move to market or do we need to wait 1-2 years for a Phase 3 to complete?
       
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    23. r34d1ng

      r34d1ng Member

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    24. Stacken77
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      Stacken77 Member Benefactor Hall of Fame

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      I'm kinda hopeful, this could be big. But it'll most likely take some time before we know if it can benefit tinnitus for sure.
       
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    25. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

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      This will be big for tinnitus. Very big. Excellent results from the initial readout and the stock price tells the story.
       
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    26. Joeseph Stope
      Innocent

      Joeseph Stope Member

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      We'll all have a big party to celebrate at Pádraigh's house. I'll be taking my tent and pitching it in your front garden. Uncork the wine glasses and the Champagne.

      Oh then there was FX-322. Hey! Wait a minute...
       
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    27. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

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      You are more than welcome. Loving the fada in the spelling too.

      Honestly though. Trobalt showed efficacy for tinnitus for many. This is more potent, without the significant side effects. Dosage for focal epilepsy is 20-25 mg, but I'd say 10 mg off label might give a tinnitus effect. All speculation, but is it really when Retigibaine was efficacious. This only focuses on the Potassium channels that are needed.

      Dr. Shore and many other reckon if we can put the brakes on these overactive cells, then tinnitus will improve. This drug will do that.

      Let's wait and see but I have great hope for this.

      FX-322 is incomparable as it was never proven for tinnitus in any shape or form. Anecdotal isn't solid proof as we were shown.
       
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    28. Matchbox
      Wishful

      Matchbox Member

      Location:
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      Cause of Tinnitus:
      Noise Induced, Prednisone (drones), Barotrauma (distortions)
      To be fair these forums would be considered case studies which is arguably not much better.

      I think the stock is being overly optimistic. Phase 3 is the big hurdle to clear.
       
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    29. Gb3

      Gb3 Member

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      12/19
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      Don’t they have fast track status from the FDA? Do they have to have a Phase 3?
       
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    30. r34d1ng

      r34d1ng Member

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      I believe they said during the call that this trial was not enough for the FDA to go straight to market and that they would need to do another one.
       
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