OZ439 or artefenomel, a molecule MMV has progressed right from discovery, is now in phase IIb combination studies with piperaquine (PQP) as a single-exposure cure in partnership with Sanofi. As children are the target population for the medicine, the OZ439-piperaquine phase IIb trial adopts a staggered approach obtaining safety data first in adults before progressing to older, then younger children, expediting the development programme. The trial is progressing well; in March 2015, a third review of the data by an Independent Safety Monitoring Board allowed recruitment to begin of children in the lowest age group (≥6 months to ≤2 years).
Rita Merino, OZ439/ 4-aminoquinoline Project Leader at Sanofi, explains the challenges in the development of this next generation medicine and what it’s like to work with MMV.
1. What are the biggest challenges the team faces in the development of this next generation antimalarial?
Primarily, it’s the time pressure. We are working to get a new antimalarial to patients before drug resistance overwhelms us. Then in terms of the development itself, the biggest challenges relate to the product characteristics. For example, OZ439 has low water solubility and PQP has a bitter taste, yet, we need to develop a formulation that can be easily absorbed and is palatable. Also, a new OZ439/4-aminoquinoline medicine would be a combination drug with at least one new chemical entity (i.e. OZ439+piperaquine, a well-known antimalarial) or two new chemical entities (OZ439+ferroquine). All the ACTs we use today were developed using two established chemical entities.
2. How will you overcome these challenges?
MMV and Sanofi are working together to solve these formulation issues by leveraging Sanofi’s chemistry, manufacturing and control (CMC) expertise and MMV’s experience and knowledge. We had a great meeting in September with specialists and people from five other pharmaceutical companies to seek out the best solutions.
3. What is the value-add of working with MMV as a partner?
MMV provides essential insights and expertise in the field of malaria drug research and development. In addition, it is focused on ensuring its products have the greatest possible public health impact – to save lives. MMV also has an extensive network of research partners and national and international policymakers. I am delighted to say we are already seeing the benefit of these links, insights and expertise in the field of malaria.