Curatis to Apply for Biologic License for C-PTBE-01 in the USA

Curatis Holding AG has announced plans to seek a Biologic License Application (BLA) in the USA for its main project, C-PTBE-01. This decision follows comprehensive evaluations done with a prominent US law firm. If approved, C-PTBE-01 will gain a market protection of 12 years, significantly longer than the 7 years offered under Orphan Drug Status.

C-PTBE-01 is a molecule consisting of 41 amino acids, meeting US Public Health Service Act criteria for a "Biologic" status. Curatis continues its pursuit of Orphan Drug Designation alongside this application.

The development of C-PTBE-01 focuses on treating Diffuse Midline Glioma (DMG), a rare and aggressive brain tumor mostly affecting children. Current treatments involve corticosteroids, which have severe side effects. C-PTBE-01 has shown promising results in reducing steroid use and side effects during clinical trials.