PolTREG and our U.S. subsidiary Immuthera have received a positive formal meeting protocol from the U.S. Food and Drug Administration (FDA). This follows a recent preIND meeting on our adaptive Phase 2/3 trial of PTG007 in children with Stage 1 and Stage 2 presymptomatic Type 1 diabetes.
Key insights from the FDA’s feedback include:
- FDA agreed that PolTREG’s clinical data in Stage 3 Type 1 Diabetes (T1D) appears sufficient to support the Prospect of Direct benefit in an adaptive Phase 2/3 study of PTG-007 in Stage 1 and Stage 2 Presymptomatic T1D patients.
- FDA is receptive to the inclusion of Stage 1 Polish patients in the trial’s statistical analyses
- FDA may consider the adaptive Phase 2/3 study as registrational, potentially expediting U.S. approval for PTG-007 in presymptomatic Type 1 diabetes.
- PolTREG and Immuthera will apply for Fast Track, Breakthrough, or Regenerative Medicine Advanced Therapy (RMAT) designation in the IND filing.
“By intervening at the earliest stage of disease—often in young children—we expect truly transformative outcomes, potentially halting progression before clinical symptoms emerge. In presymptomatic pediatric patients, autologous TREG cells represent the optimal strategy due to the safety profile and demonstrated efficacy in Stage 3 patients. If successful, PTG-007 would become the world’s first therapy registered at this earliest stage of Type 1 diabetes—a milestone critical for securing strategic partnerships.” – said Prof. Piotr Trzonkowski, CEO of PolTREG and Immuthera.
