Characterizing pharmacokinetic (PK) and pharmacodynamic (PD) parameters of recently approved drugs is important to further understand or identify biomarkers in a real-world patient population.
During development, drugs are studies in a select group of disease-specific patients thereby limiting the understanding in a broader more complex patient population. Our mission at Alimentiv is to transform human health and our Precision Medicine team is committed to defining optimal dosing strategies and identifying biomarkers that can be used to personalize therapy in clinical practice.
Currently, we are using a population PK approach to characterize the drug concentration-time profiles of an approved IBD biologic therapy in patients with severe-acute ulcerative colitis. The objective of this study is to define covariates that explain the interindividual variability in PK parameters to enable optimal dosing.
Additionally, we are conducting an open-label, prospective cohort study of a recently approved small molecule to identify and characterize PK and PD biomarkers in patients with ulcerative colitis. The identification of predictive biomarkers will enable the right patients to be treated with the right dose to maximize efficacy and minimize the risk for adverse events.