PolTREG, a clinical-stage biotechnology company developing autoimmune disease therapies, has seen its lead asset — polyclonal Treg cell therapy PTG-007 — demonstrate significant insulin secretion restoration in patients with early-onset type 1 diabetes.
The clinical-stage Treg therapy has also exhibited a longer period of disease remission in patients compared to a standard of care control in a long-term clinical study evaluating the drug’s efficacy and safety.
The study was performed in paediatric patients, who were provided the Treg therapeutic for 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 didn’t
- 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 (disease period with low insulin requirement/insulin independence) was significantly longer in patients who received PTG-007 — with a preliminary estimate at three to four years of remission seen in patients.
“This study is a confirmation that the efficacy we observed in the 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, as well as the serious long-term complications of the disease,” said CEO of PolTREG, Prof. Piotr Trzonkowski.
With this study, PolTREG has fulfilled a requirement by the European Medicines Agency to confirm the safety of Treg therapy for a minimum of five years after administration.
