FDA Schedules Type B Meeting for Curatis' Phase 3 Corticorelin Trial

Curatis Holding AG, based in Liestal, Switzerland, has announced that the U.S. Food and Drug Administration (FDA) will conduct a Type B meeting in the third quarter of 2025. This meeting will review the clinical development plan for corticorelin, an investigational biologic targeting Peritumoral Brain Edema (PTBE).

The planned discussion aims to align on the pivotal Phase 3 trial design, slated for 2026, focusing also on critical non-clinical and manufacturing details. CEO Dr. Roland Rutschmann emphasized the importance of this step in reducing steroid use among PTBE patients.

Corticorelin, a 41-amino acid polypeptide, has shown potential in preclinical and clinical studies to enhance quality of life by reducing or replacing steroid usage. This drug remains investigational and is not approved for therapeutic use in any country.