PolTREG’s type-1 diabetes Treg cell therapy PTG-007 demonstrates long-term safety and efficacy

PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced 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.

The results come from 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 seven to 12 years.

The main findings were that patients who received PTG-007 continued to secrete insulin, while untreated patients in the control group did not, and that 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 three and four years, though that number still needs to be confirmed in final results.

Piotr Trzonkowski, chief executive of PolTREG, said: "This long-term study is a confirmation that the significant efficacy we found in our Phase I/II 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."