We are pleased to announce that the first patient has received therapy as part of the Phase II PreTreg clinical trial targeting pre-symptomatic type 1 diabetes. The study will enroll 150 children aged 3–18 who, due to genetic predisposition, are at high risk of developing type 1 diabetes but have not yet shown any symptoms.

PolTREG has the potential to develop and register the first therapy in the world that prevents the onset of clinical symptoms of type 1 diabetes. This innovative approach has also been recognized by the U.S. FDA, which acknowledged the study as potentially registrational. It may allow for inclusion of Polish patients in statistical analyses of U.S.-based trials.

“Long-term study results in symptomatic type 1 diabetes confirm the efficacy and safety of the therapy developed by PolTREG. Globally, medicine is increasingly focused on interventions that begin before the first symptoms of disease appear — and our therapy fits seamlessly into this trend. By applying it at the earliest stage of disease development, we expect very promising outcomes — potentially even halting the disease before clinical symptoms emerge. If the trial confirms the therapy’s efficacy, we may be able to develop and register the world’s first drug that prevents the onset of type 1 diabetes symptoms. We believe this therapy has strong market and partnering potential.” – said Prof. Piotr Trzonkowski, CEO and Co-founder of PolTREG.

The PreTreg trial is being conducted with support from the Polish Medical Research Agency (grant no 2022/ABM/05/00001 – 00), which awarded a grant of PLN 31.7 million. Recruitment is already underway at university hospitals in Białystok, Gdańsk and Łódź, and will expand to six additional clinical centers across Poland.

Our goal is to intervene before autoimmune destruction of insulin-producing cells progresses, offering patients a chance to remain symptom-free — and clinically healthy — despite their high genetic risk.

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