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Results From a Phase-I Clinical Trial of IMCY-0098

Discussion in 'Research' started by joshualevy, Mar 9, 2020.

  1. joshualevy

    joshualevy Approved members

    Dec 30, 2008
    IMCY-0098 is an immune therapy designed to cure/prevent type-1 diabetes by teaching the immune system not to attack beta cells. The treatment is being developed by the Imcyse company, but this clinical trial is run by academic researchers in Europe as part of a European Union research project which targets T1D.

    This trial is the first test in people. It enrolled 41 honeymooners into four groups, a control group and three different dose groups. No safety issues were found, but the people who were treated did not see any improvement to their T1D. There was no improvement in C-Peptide generation (meaning no improvement in beta cells) and the people used about the same levels of insulin.

    The results of this study have been reported as a poster at a conference and the company has issued a press release, but there has not been a journal article.


    The results from this study reminded me that companies that sponsor research are almost always very positive about the outcomes of that research, even when (objectively) those outcomes are disappointing. If you read the press releases for clinical studies put out by the sponsoring companies, they often work very hard to find even a tiny silver lining in a study that has failed. This is why I look at the data from the study and decide if it is a failure or not, and do not pay much attention to the researcher's opinions.

    It is important to remember that even in a total disaster, you can always be positive about some small detail, or weaken the definition of success to the point were mediocre news suddenly becomes a success. Take a look at this:

    No statistically significant differences could be observed in the different dose cohorts, but trends towards better outcomes in higher dose cohorts were [observed]. ​

    "Statistically significant differences" is the standard for determining if a clinical trial is successful or not, so this trial was not successful. "Trends towards better outcomes" is a lower standard, which the company is talking about specifically because it has failed in the normal definition of success.

    In the press release, the company (via its Chief Medical Officer) is very positive about future clinical trials. If there are future clinical trials, then I'll certainly cover them. However, I'll wait for better results before getting excited about this research. So far, it has one unsuccessful clinical trial, and no successful ones.

    Results Poster: http://www.arianapharma.com/wp-content/uploads/2019/10/Poster-T1D-EASD-Final-PDF.pdf
    Interim Results: https://www.easd.org/virtualmeeting...diabetes-e381b2d6-766b-4c4d-acc7-27337bb80b32
    Clinical Trial Registry: https://www.clinicaltrials.gov/ct2/show/NCT03272269
    Clinical Trial Registry for extension: https://clinicaltrials.gov/ct2/show/NCT04190693
    Press Release: https://www.biospace.com/article/imcyse-reports-successful-first-in-human-phase-1b-study-in-type-1-diabetes-with-imcy-0098/
    Project summary: https://cordis.europa.eu/project/rcn/110445/reporting/en?rcn=3862

    Joshua Levy
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

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