An innovative, modified release methotrexate tablet for children with juvenile idiopathic arthritis

ROS Theraputics ApS has developed a modified release tablet formulation of methotrexate (Trexior) for the treatment of juvenile idiopathic arthritis (JIA). Under this grant, the partners (ROS Therapeutics (ROS) – Denmark, CTC Clinical Trial Consultants (CTC) – Sweden, and Smerud Medical Research Norway (SMRNOR) – Norway) intend to conduct pharmacokinetic studies to demonstrate bioequivalence and bioavailability compared with state-of-the art for the treatment of JIA. In addition, we will prepare and submit a paediatric investigation plan (PIP), prepare other documentation in order to facilitate the submission of the common technical document for MAA in the six months post-grant, and secure the business and IPR plans for commercialisation of Trexior.