MTXReF: An innovative, modified release methotrexate tablet with superior treatment advantages.

We intend to develop a modified release tablet formulation of methotrexate, MTXReF, with significantly improved bioavailability compared with state-of-the art. In this project, we will conduct pharmacokinetic studies with alternative formulations and strengths in adult patients with rheumatoid arthritis and in pediatric patients with juvenile idiopathic arthritis. Overall, the work packages include: 1. Overall project/consortium management 2. GMP Manufacturing – small scale 3. Bioanalysis of methotrexate – incl method development 4. Pivotal clinical study in adult RA patients 5. Pivotal clinical study in juvenile idiopathic arthritis patients (children) 6. Regulatory Affairs