Modeling and Simulation Supports Competitive Dose

Assessment and go/no go decision in Alzheimer’s Disease modeling strategy provided sponsor with rational basis for product profile evaluation to avoid placing non-competitive dose into Phase 3, saving $85 Million and redirecting resources towards other programs.

A global pharmaceutical company was seeking to advance its drug candidate, indicated for symptomatic treatment for Alzheimer’s Disease (AD), into pivotal Phase 3 trials. Data from Phase 1 and 2 studies were available on the drug candidate, including Phase 2a and 2b safety and efficacy studies in AD patients.

As the sponsor prepared its pivotal trial strategy, it became critical to provide a rational basis for Phase 3 dose selection and to establish a comprehensive picture of the drug candidate’s efficacy profile versus Aricept® (donepezil), the “gold standard” treatment for AD.