Modeling strategy enabled sponsor to provide rational basis for Phase III dose selection and avoid additional dose-ranging study, saving 12 Months and $6 Million.
A global pharmaceutical company was seeking to advance its drug candidate, indicated for the treatment of osteoporosis, into pivotal Phase III trials. Data from Phase I and II studies were available on the drug candidate, including a Phase IIB dose-ranging trial currently underway.
As the sponsor prepared for a rigorous internal and external review of its clinical data and requirements for its confirmatory studies, it became critical to establish a comprehensive picture of the drug candidate’s efficacy profile. Specifically, the sponsor sought to establish a quantitative basis for the minimally effective dose to take into Phase III studies.