PolTREG and Immuthera Advance TREG Cell Therapy for Type 1 Diabetes with Positive FDA Feedback

WARSAW, POLAND — PolTREG S.A. and its U.S. subsidiary, Immuthera, announced that the U.S. Food and Drug Administration (FDA) has provided a positive opinion, confirming that the company’s clinical data appears sufficient to support an Investigational New Drug (IND) application for PTG-007. The therapy, an autologous TREG cell therapy, is being developed for presymptomatic Type 1 diabetes (T1D). The FDA’s feedback paves the way for a registrational adaptive Phase 2/3 trial.

Key Takeaways from FDA Feedback

The formal protocol from the recent pre-IND meeting outlines several points that could significantly accelerate the development of PTG-007:

• Potential for Expedited Approval: The FDA indicated that the proposed adaptive Phase 2/3 study may be considered a registrational trial, which could expedite the U.S. approval process.
• Study Design: The FDA agreed that the planned double-blind study design, which includes four treatment groups and stratification by age, is reasonable and that the potential benefits of the treatment appear to outweigh the risks.
• Inclusion of Polish Patients: The agency is receptive to including Stage 1 Polish patients in the trial’s statistical analysis, which could help lower costs and speed up the timeline for initial data.
• Expedited Pathways: The company plans to apply for Fast Track, Breakthrough, or Regenerative Medicine Advanced Therapy (RMAT) designation, any of which could substantially streamline the regulatory process.

Professor Piotr Trzonkowski, CEO of both Immuthera and PolTREG, stated that the FDA’s feedback is “exceptionally encouraging.” He highlighted the company’s focus on intervening at the earliest stage of the disease, particularly in young children, with the goal of halting progression before clinical symptoms appear.

Broader Strategy and U.S. Presence

PolTREG’s strategy is to intervene early in the disease using its PTG-007 autologous TREG cell therapy. Trzonkowski described this as the “optimal” approach for presymptomatic pediatric patients due to its safety and efficacy profile demonstrated in later-stage patients.

In a move to strengthen its U.S. presence, the company has recently established its subsidiary Immuthera, appointed key diabetes and neuroimmunology experts to its Scientific Advisory Board, and partnered with Noble Capital Markets and Kinexum Services to support its U.S. registration efforts. The company plans to file its formal IND request with the FDA in the coming weeks.