Case Study: DNDi achieves EMA positive scientific opinion for acoziborole with Certara

DNDi helps secure EMA positive scientific opinion for acoziborole with Certara

The Drugs for Neglected Diseases initiative (DNDi) needed to support the approval of acoziborole, a new treatment for sleeping sickness. The challenge was to assess the drug's potential for interactions and its metabolism in different age groups, complicated by its long half-life. Certara was engaged to provide its expertise and use its Simcyp Simulator for physiologically-based pharmacokinetic (PBPK) modeling.

Certara applied model-informed drug development strategies to minimize the number of clinical studies required. This efficient approach provided the necessary evidence for the regulatory submission. As a result, acoziborole received a positive scientific opinion from the EMA via an accelerated pathway, a critical step towards making this single-dose oral treatment available to patients and supporting the disease's elimination.

DNDi