Efficacy and Safety of BGG492 (Selurampanel) in Patients with Chronic Tinnitus

Discussion in 'Research News' started by Tigo, Mar 3, 2021.

    1. Tigo

      Tigo Member

      Tinnitus Since:
      2 years
      Cause of Tinnitus:
      genetic hearing loss
      Efficacy and safety of single and repeated selurampanel dosing for 2 weeks in patients with chronic subjective tinnitus

      Abstract

      To evaluate efficacy and safety of BGG492 (selurampanel; an orally active, competitive AMPA glutamate receptor antagonist) in patients with moderate-to-catastrophic chronic subjective tinnitus.

      Study enrolled patients with subjective tinnitus based on THI severity grade 3, 4 or 5 (moderate, severe or catastrophic), and those with chronic (>6 and <36 months) tinnitus.

      Primary endpoints were clinical status of tinnitus using TBF-12 and tinnitus loudness using VAS after multiple dose 2-week BGG492 treatment.

      Safety was assessed by recording all adverse events (AEs).

      After a single dose of BGG492 VAS scores for tinnitus loudness (P=0.012) and tinnitus annoyance (P=0.004) were significantly reduced vs placebo. After 2 weeks treatment a significantly greater proportion of patients showed improvement of ≥4 points from baseline in TBF-12 (stringent responder definition) with BGG492 vs placebo (26.7% [n=23] vs 14% [n=12], respectively; odds ratio [OR] (90% CI):2.30 (1.10, 4.83); P=0.064), fulfilling proof-of-concept achievement criteria. No notable difference in proportion of responders to BGG492 vs placebo was observed as assessed using VAS (26.7% [n=23] vs 27.6% [n=24], respectively; OR (90% CI):0.94 (0.52, 1.67); P=0.848). Dizziness was the most frequently reported AE in 50% [n=21] and 31.5% [n=17] patients on BGG492 100 and 50mg TID, respectively vs 9.6% [n=9] on placebo.

      In conclusion, BGG492 showed reduction of both tinnitus loudness and annoyance after a single dose and reduction of tinnitus handicap after 2 weeks of treatment in patients with chronic subjective tinnitus, thereby supporting further clinical investigation of AMPA receptor antagonists with an improved benefit/risk ratio. A dose of 100mg TID BGG492 showed higher efficacy but somewhat lower tolerability compared to 50mg TID.

      Source:
      https://pubmed.ncbi.nlm.nih.gov/33637230/
       
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    2. 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
      Interesting stuff. Would like to take a closer look at the research, but top-line significant values look good.
       
    3. GBB

      GBB Member Hall of Fame

      Location:
      NYC
      Tinnitus Since:
      2016-2019 (Mild, Cured) 8/2020 (Severe)
      Cause of Tinnitus:
      Virus / Microsuction / Acoustic Trauma
      Where can I go to become BGG492 foie gras? I want this saturating all of my tissues ASAP.
       
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    4. ThomasC
      Lonely

      ThomasC Member Benefactor

      Location:
      France
      Tinnitus Since:
      2012
      Cause of Tinnitus:
      hearing loss
      I read this drug's development was discontinued in 2017. It was first designed for migraine and the drug reached Phase II but it didn't show positive results.
       
    5. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      That's how science works, sometimes hypertension medicine ends up becoming viagra.
       
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    6. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Looks like they are looking to redevelop it for a different indication (tinnitus). It has a similar mechanism of action as OTO-313 so the fact that they are using it on chronic patients is pretty exciting.
       
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    7. 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
      This was sort of my thinking for publishing in 2021 after a 4-year gap from the study. Don't know if its normal to be honest.
       
    8. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
      Well,
      Study start date: January 2011
      Actual study completion date: January 2012

      Only Novartis as contact (no indication of researchers like Mr. Langguth)
      + weird reply from Novartis to me 7 years ago.

      And then only "2 weeks after treatment" (overall duration of the follow up?)
       
    9. BuzzyBee
      Bookworm

      BuzzyBee Member Benefactor

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Not Sure
      I'm happy for those chronic patients who were lucky enough to get to try it. It seems like whenever I ask a health provider about some new tinnitus treatment they are either totally unfamiliar with it or negative towards it.
       
    10. ThomasC
      Lonely

      ThomasC Member Benefactor

      Location:
      France
      Tinnitus Since:
      2012
      Cause of Tinnitus:
      hearing loss
      Do they have to start from scratch? If the drug is safe and if they reached Phase II for the migraine trial, I guess they can skip Phase I?
       
    11. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      There are some pretty bad side effects for systemic Glutamate receptor antagonists. I think the bigger take away would be that this might have a lot of potential for sparing use but more importantly that chronic tinnitus might be addressed this way with local drugs (e.g., OTO-313 or a similar compound).
       
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    12. MadsWithT
      No Mood

      MadsWithT Member Podcast Patron Benefactor

      Location:
      Norway
      Tinnitus Since:
      1997
      Cause of Tinnitus:
      See bio
    13. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Location:
      Mexico
      Tinnitus Since:
      June 2020
      Cause of Tinnitus:
      NIHL
      Does that mean that this drug is not a feasible treatment? Short term or long term?
       
    14. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      I don't think it's a feasible long term treatment. It could be safe briefly/sparingly though not sure.
       
    15. GBB

      GBB Member Hall of Fame

      Location:
      NYC
      Tinnitus Since:
      2016-2019 (Mild, Cured) 8/2020 (Severe)
      Cause of Tinnitus:
      Virus / Microsuction / Acoustic Trauma
      My hope/assumption is if they revisit this it would be a localized solution as you say.
       
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