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     145  0 Kommentare PolTREG’s type-1 diabetes Treg cell therapy PTG-007 demonstrates long-term safety and efficacy for up to 12 years

                    

    • PTG-007 administration resulted in improved remission and insulin secretion
    • Patients monitored for up to 12 years
    • Planned pivotal Phase 2/3 study is final step for PolTREG to bring PTG-007 to market

    Gdańsk, Poland – 24 June 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care, in a long-term clinical study into the safety and efficacy of lead asset PTG-007. The study monitored pediatric patients who received the autologous treatment over a period of 7 to 12 years.

    The main findings were:

    • Patients who received PTG-007 continued to secrete insulin, while untreated patients in the control group did not,
    • Safety measures showed no significant difference in the health status of patients who received Treg therapy compared to the control group,
    • The duration of disease remission - the period of disease characterized by moderate severity of disease symptoms with low insulin requirement or insulin independence - was significantly longer in patients who received PTG-007 compared to the control group. A preliminary estimate is that the difference was between 3 and 4 years, however, that number still needs to be confirmed in final results.

    “This long-term study is a confirmation that the significant efficacy we found in our Phase 1/2 clinical trial for PTG-007 is sustainable over the long term. At PolTREG, we believe that PTG-007 has the potential to prevent type-1 diabetes, freeing patients of the life-long burden of having to take frequent insulin injections, and the serious long-term complications of the disease. The results of this study are an important step in that direction,” said Prof Piotr Trzonkowski, Chief Executive Officer of PolTREG.

    With the study, PolTREG has fulfilled a requirement by the European Medicines Agency to confirm the safety of Treg therapies at least 5 years after their administration. To the best of PolTREG’s knowledge, no other company currently can show similar long-term safety results of Treg therapy in T1D. This is a significant competitive advantage, and paves the way for the company to launch a pivotal Phase 2/3 study of PTG-007 to treat T1D.

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    PolTREG’s type-1 diabetes Treg cell therapy PTG-007 demonstrates long-term safety and efficacy for up to 12 years                  PTG-007 administration resulted in improved remission and insulin secretion Patients monitored for up to 12 yearsPlanned pivotal Phase 2/3 study is final step for PolTREG to bring PTG-007 to market Gdańsk, Poland – 24 …