Certara Simcyp® Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib

Core Insights - Certara, Inc. announced that its Simcyp Simulator's physiologically-based pharmacokinetic (PBPK) modeling predictions were accepted by the U.S. FDA to support the new drug application (NDA) for asciminib, demonstrating the effectiveness of model-informed drug development approaches in regulatory decision-making [1][2] Group 1: Drug Development and Regulatory Impact - PBPK modeling utilizes virtual biological systems to predict drug absorption, distribution, metabolism, and elimination, increasingly replacing certain clinical studies [1] - The results from the PBPK modeling for asciminib provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA process [2] - The collaboration on asciminib's modeling evolved over a decade, enhancing understanding of its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval [3] Group 2: Asciminib and Chronic Myeloid Leukemia (CML) - Asciminib is a first-in-class allosteric inhibitor targeting the BCR::ABL1 myristoyl pocket, used for treating Chronic Myeloid Leukemia (CML) [2] - The global incidence rate of CML was approximately one case per 100,000 population in 2018, accounting for about 15% of newly diagnosed leukemia cases in adults [2] - PBPK modeling enabled a mechanistic assessment of asciminib's pharmacokinetics across diverse patient populations and dosing regimens [2] Group 3: Company Overview - Certara accelerates medicine development using biosimulation software and services, serving over 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [4]