FluoGuide reaches milestone with FG001 for phase III clinical supply

Copenhagen, Denmark, 8 November 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to inform that the first large scale batch for its lead product FG001 has been successfully manufactured in preparation for phase III clinical development. 

FluoGuide has successfully collaborated with its supplier PolyPeptide since the very first synthesis of the FG001 API (Active Pharmaceutical Ingredient). FG001 is a clinical development project that was started in 2020 for the novel treatment of aggressive brain cancer. A first large scale batch has now been successfully manufactured by PolyPeptide in preparation for phase III clinical development.

For the pivotal phase III clinical trials, FluoGuide with the support of PolyPeptide has scaled up the manufacturing of FG001 to commercial scale. As part of the clinical process, FluoGuide now plans for three validation batches in commercial scale to be documented and included in the registration package for commercial approval.

Obtaining success with the first Phase III batch is therefore an important milestone for the preparation of any phase III trials and commercialization of FG001.

Morten Albrechtsen, CEO FluoGuide says “The completion of the first large scale GMP batch is a milestone for our lead product FG001, as it paves the way towards the next clinical steps and bringing us closer to commercialization”.

Neil Thompson, Director Global Sales and Marketing, Polypeptide says: “We are thankful for the opportunity to work with FluoGuide on the highly innovative FG001 project and congratulate the whole team for reaching this milestone."