Medivir AB announced that it has signed an agreement with Lonza for the manufacture of a new GMP campaign of fostrox drug substance for the planned phase 2b to enable study drug availability end of 2024 and ensure maximum momentum in the fostrox development program. In addition, Lonza, Medivir's partner for process development and manufacture of drug substance, has developed a process suitable for commercial manufacture of fostrox drug substance with plans underway for the final optimization, qualification and validation activities needed to support an accelerated approval after the planned phase 2b study. Lonza will also provide expert regulatory services to Medivir.

Based on promising clinical data for fostrox + Lenvima in the ongoing phase 1b/2a study in second line HCC, together with the lack of approved medical treatments after tumor progression on first line standard of care, the company has communicated the plan to initiate phase 2b study with accelerated approval intent. A GMP campaign of fostrox, produced with an updated process suitable for commercial manufacture, is critical to enable study start of the planned study.