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Biotech / Medical : Immunomedics (IMMU) - moderated
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From: scorman111/26/2024 1:11:43 PM
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Down history lane:
Back in March 2019, Biogen terminated it's (2) phase 3 trials:

Aduhelm, an Alzheimer's drug developed by Biogen, failed its Phase 3 clinical trials, meaning it did not demonstrate significant efficacy in treating the disease despite showing a reduction in amyloid plaques in the brain; this led to the companies involved stopping the trials early due to a futility analysis indicating unlikely success in achieving the primary endpoint of cognitive improvement.

Key points about Aduhelm's Phase 3 failure:

Lack of clinical benefit:

Although the drug effectively reduced amyloid plaques, the clinical trials did not show a significant improvement in cognitive function in patients, leading to concerns about its real-world effectiveness
  • Early termination of trials:
    Based on the futility analysis, Biogen and Eisai decided to stop the Phase 3 trials (ENGAGE and EMERGE) early as it was unlikely to demonstrate a positive outcome.
    Controversial FDA approval:
    Despite the failed Phase 3 trials, the FDA granted accelerated approval to Aduhelm in 2021, which was met with criticism due to concerns about the drug's efficacy and potential side effects.


    the published trial results were posted here:
  • Aduhelm trial


    • slide 7 shows baseline with key MMSE of 26
    " The top score for the MMSE is 30. A score of 25 or higher is said to be normal. A score of below 24 could mean cognitive impairment."....so at best the patients were very early onset

    slide 9 shows results at 78 week with a corresponding minimal placebo decline as expected

    Rick Barry claimed that patients responded positively to treatment.
    But TLR does NOT address specific cohorts.
    They will do some data mining to discover the super responders which are many.
    Unblinding the second phase 3 will allow 18mo placebo data to enter the equation, as well as cohorts with much more aggressive disease that "early".
    The 12month data pool will be doubled.
    Extensions from OL and continuation trials should all be tabulated going out as much as 4 years.
    It took 7 weeks from trial end to TLR, which puts us at the end of January.

    I am cautiously optomistic that if Biogen did data mining, we will have better numbers. It ain't over till it's over.
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