miRStra® is a saliva-based diagnostic kit designed to measure miR-485-3p, our first AD biomarker. The expression of this particular miRNA is abnormally increased in the brains of AD patients and is associated with multiple hallmarks of AD such as amyloid plaque deposition, phospho-tau aggregation, neuroinflammation and others.

miRStra® was shown to have a high prediction power for the amyloid PET results among MCI patients, and thus can be used as a non-invasive, cost-efficient initial AD screening kit prior to the amyloid PET scan. miRStra® will be used as a companion diagnostic kit for selecting patients and monitoring treatment effect during BMD-001’s clinical trial.

Clinical approaches: Biomarker-driven Clinical Trials

Biomarker-driven clinical trials have been attempted with findings on the pathophysiologically relevant biomarkers and with advances on the technologies to screen the suggested biomarkers. We are taking the advantages of miRStra® to adopt this strategy for the treatment of the AD in the following points:

  • Target Validation

    The newly developed biomarker (miR-485-3p) for AD can be easily screened with miRStra® using saliva and plasma samples of the patients in a non-invasive, cost-efficient way and can predict amyloid burden with high accuracy.

  • Patient screening

    Among the patients diagnosed for AD, biomarker-driven clinical trial for our candidate AD drug will be conducted based on individual’s microRNA expression level measured with miRStra®.

  • Monitoring treatment effect

    Throughout clinical trials, patients will be monitored closely with biomarker analysis to monitor treatment efficacy.