Biomarkers are indispensable tools for the diagnosis of diseases, confirmation of the mechanism of action of pharmaceutical products and responses to therapeutic interventions, and evaluation of drug safety/toxicity. They have been used to provide information on proof of mechanism of compounds in drug development process and as surrogate markers for drug efficacy evaluation in clinical studies.
Shionogi has been conducting biomarker research and establishing new biomarkers with the aim of improving drug development efficiency and clinical predictability in drug discovery research. Furthermore, we aim to maximize the value of our pharmaceutical products and promote their appropriate use by developing and launching useful biomarkers as in vitro diagnostics (IVD).
The brain natriuretic peptide (BNP) test developed by Shionogi is the first IVD in the world and is widely used in daily medical practice as the most useful clinical test essential for the diagnosis, severity assessment, and prognosis prediction of heart failure. It is listed as a biomarker with a high level of evidence in the Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure (Revised in 2017: Joint Guidelines by the Japanese Circulation Society and the Japanese Heart Failure Society). In October 2019, we launched 'BNP Control Shionogi' a reference standard material for the BNP test, for precision control in the determination of BNP. 'BNP Control Shionogi’ can contribute to improve the reliability of clinical diagnoses with the aim of maintaining test precision in institutions and reducing differences in measured values among institutions.

Biomarkers are utilized in all stages of drug development

Shionogi’s biomarker research focuses on two technologies: imaging marker research and molecular biomarker research. In the future, we will promote clinical research to utilize biomarkers as tools to evaluate the validity of drug targets and identify the right patients to deliver the drugs.

Imaging Biomarker

Imaging techniques enable highly sensitive and quantitative analysis of morphology and function in the living tissues, such as brain, heart and kidneys. As imaging can also provide useful insights for translational research from non-clinical to clinical study, it is noticed as an innovative technology that increases the success rate of drug development. To determine the optimal dosage of new drugs and assess drug efficacy, we are studying on the measurement of receptor occupancy by Positron Emission Tomography (PET, upper right figure) and evaluation of brain neural network by Magnetic Resonance Imaging (MRI, lower right figure). In addition, imaging technique is useful tools to evaluate the validity of drug discovery targets and identify the right patients, because it can be performed on living humans.

Molecular Biomarker

Molecular biomarkers are extremely useful in facilitating development and research of new pharmaceutical drugs. Molecular biomarkers, such as proteins, genes, and metabolites, help in understanding the changes in a living body caused by pharmaceutical drug administration and pathological conditions. Therefore, molecular biomarkers can promote the appropriate use of pharmaceutical drugs. We are conducting research to explore new biomarker molecules and validate known molecules. We aim to (1) select patients appropriately to maximize the value of pharmaceutical drugs and (2) improve the efficiency and success probability of clinical development (clinical trials). For example, we are conducting research on biomarkers for efficacy prediction based on the mechanism of action as a life cycle management (LCM: Initiatives for long-term effective use of launched drugs) study of Pirespa® (generic name: pirfenidone), a therapeutic drug for idiopathic pulmonary fibrosis (IPF).