Update on AM-101 (aka Keyzilen)

Discussion in 'Research News' started by Aaron123, Jun 15, 2016.

tinnitus forum
    1. I've attached the presentation from Auris Medical's "Key Opinion Leader" meeting held today (June 14). They seem pretty confident (though they were talking to investors....) and have officially named AM-101 as "Keyzilen".

      There are four parts to the presentation. The first is an introduction; the second is a detailed discussion of the TACTT trials including endpoints required for regulatory approval; the third is a discussion by Hinrich Staecker about inner ear tinnitus; and the last is a market analysis.

      The discussion of requirements for regulatory approval are interesting. They will need to show significant and clinically meaningful improvement over placebo in tinnitus loudness and the TFI for TACTT2. Also of note: the randomization was 3 to treatment for each 2 to placebo.

      More comments later...

      Attached Files:

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    2. Ian Mac

      Ian Mac Member

      Tinnitus Since:
      Cause of Tinnitus:
      Vestibular Nueritis, loud music (dubstep)
      Sweet. Sound good keep us updated.
    3. bellringer

      bellringer Member

      Tinnitus Since:
      Cause of Tinnitus:
      Based on the numbers in the powerpoint, Auris expects to generate drug revenues in the amount of $3000 an ear, not including ENT injection costs.
    4. Jean-Philippe

      Jean-Philippe Member

      Tinnitus Since:
      Cause of Tinnitus:
      ear infection
      Does this means am101 works?
      • Good Question Good Question x 2
    5. Paromita

      Paromita Member Benefactor

      Tinnitus Since:
      April 2016
      Cause of Tinnitus:
      Not sure, maybe dental and facial nerve
      Interesting presentation, so why they don't have any data on how many people got cured ?
      • Good Question Good Question x 1
    6. whale
      No Mood

      whale Member Benefactor

      Tinnitus Since:
      Cause of Tinnitus:
      Myofascial crap Bruxism, a jackhammer, stress who knows
      This 2015 article say:

      "Auris is in late-stage trials of AM-101, a derivative of the anesthetic ketamine, which it hopes will dampen the aberrant signaling in the auditory nerve that is perceived as tinnitus. In a midstage trial, the drug, injected into the middle ear, was not more effective overall than a placebo. But a subset of patients whose tinnitus was caused by trauma or infection said the drug made the sound in their ears softer, less annoying and less disruptive of sleep."

      Investors appear to be cautious given the challenges. Auris went public on Nasdaq in August at $6 a share, using the trading symbol EARS. The stock is now trading at about $4.

      Keep an eye on that stock. I think its at 4.75 ,if its gets about 7 people are starting to believe, but they also have a hearing loss drug. I heard the Department of Defense is a big investor, so thats hopeful.

    7. Paul Fisher

      Paul Fisher Member

      Tinnitus Since:
    8. Ian Mac

      Ian Mac Member

      Tinnitus Since:
      Cause of Tinnitus:
      Vestibular Nueritis, loud music (dubstep)

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