PolTREG moves forward with the European registration process for TREG therapy in type 1 diabetes
- The European Medicines Agency (EMA) has officially qualified PolTREG to submit an application for marketing authorization in the European Union for the PolTREG-T1D cell preparation.
GDAŃSK, Poland, March 10, 2026 (GLOBE NEWSWIRE) -- PolTREG SA (WSE: PTG), a pioneer and global leader in the development of therapies using T-regulatory lymphocytes (TREGs), announces that a significant milestone has been achieved in the process of registration of cell therapy for the treatment of symptomatic type 1 diabetes in the European Union.
The European Medicines Agency (EMA) has officially confirmed that the Committee for Medicinal Products for Human Use (CHMP), based on the studies and documentation presented by the Company, has qualified the TREGs cells preparation product – PolTREG-T1D (PTG-007) for submission of an application for marketing authorization under the centralized procedure in the European Union.
The Committee for Medicinal Products for Human Use (CHMP) made the decision after analyzing the clinical trial results presented by PolTREG to date. The Committee highly valued the substantive content of the documentation, which allows the Company to apply for marketing authorization for a pediatric indication. This is important because type 1 diabetes (T1D) most often begins in childhood. The autoimmune process is most aggressive in young children, and as a result, the pancreatic beta-cells responsible for insulin secretion are completely destroyed, and the patient is subjected to a lifelong regimen of daily glucose monitoring and insulin supplementation.
PolTREG submitted globally unique data from 7–12 years of patient follow-up (clinical trials conducted by PolTREG) in support of the application for registration. These data confirmed that TREG therapy not only has an unprecedented safety profile but, above all, inhibits disease progression and maintains long-term endogenous insulin secretion. The EMA initially expected 5-year data, but PolTREG provided scientific evidence spanning over a decade, placing the PTG-007 project in a "best-in-class" position.
"The EMA's decision confirms the superior quality of our therapy and is a huge step towards commercialization. The fact that the CHMP has qualified our therapy for the central procedure means that our clinical data – including the unique 12-year follow-up results – have been recognized as a solid foundation for registering the therapy on the European market. We are the first company in the world to provide such long-term evidence of the effectiveness and safety of TREGs. We see that regulators appreciate our contribution to the development of targeted medicine, which, unlike insulin therapy, addresses the cause of the disease, not just its symptoms. The EMA registration process concerns the treatment of type 1 diabetes in the early symptomatic phase (stage 3). In the pre-symptomatic phase of type 1 diabetes (stages 1 and 2), we are currently conducting clinical trials in children in Poland and are also planning them in the US."– says Prof. Piotr Trzonkowski, Ph.D., MD, PhD, co-founder and President of the Management Board of PolTREG SA
The EMA's positive assessment of PolTREG's application places the company at the center of attention in the global pharmaceutical industry. The history of the biotechnology market shows that the registration of an innovative therapy for type 1 diabetes is a direct factor in concluding multi-billion dollar deals.
The next steps at the EMA. Confirmation of eligibility triggers the formal registration timeline:
- designation at the EMA, at the Company’s request, of a dedicated administrative and substantive team dealing with the registration process;
- Submission of the full Dossier (MAA): The Company is finalizing the preparation of the full technical and clinical documentation;
- After submitting the application, there is a substantive assessment phase (usually lasting approximately 210 days of pure assessment time, not including the so-called clock-stops for agency questions);
- After obtaining a positive opinion from the CHMP, the European Commission issues a central marketing authorization valid in all EU and EEA countries.
PolTREG estimates that the full schedule of meetings and assessments (the so-called EMA calendar) will be finalised within the next two months.
PolTREG is a biotechnology company focused on developing innovative therapies using T-regulatory lymphocytes (TREGs), as well as developing combination therapies combining TREGs with antibodies. The company is a global leader in cell therapies based on polyclonal TREG cells. The company's scientists and co-founders conducted the world's first human administration of a TREG preparation. Therapeutic areas in which PolTREG therapies are being developed include various autoimmune diseases such as type 1 diabetes, multiple sclerosis, and amyotrophic lateral sclerosis.
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