PolTREG S.A. , a clinical-stage biotechnology company focused on developing cellular therapies for autoimmune diseases, announced promising long-term data from its Treg cell therapy, PTG-007, for patients with type-1 diabetes (T1D). Results showed that some patients achieved clinical remission for up to 12 years, with a subset remaining insulin-independent for 18 to 24 months post-treatment. The data will be presented at the INNODIA EASD symposium in Madrid.
“Type-1 diabetes requires a life-long commitment to care. Our results show that PTG-007 offers a path to long-term clinical remission, freeing some patients from the daily burden of insulin injections,” said Prof Piotr Trzonkowski, CEO of PolTREG.
The study followed 54 patients from Phase I and II trials, monitoring their outcomes over a period of 7 to 12 years. Key findings included sustained insulin independence for some patients and clinical remission defined as minimal insulin requirements with effective metabolic control. Patients who received Treg therapy combined with anti-CD20 treatment (rituximab) showed the best results.
The study analyzed over 700 variables across multiple organ systems and found no significant differences compared to standard-of-care, with no severe adverse effects reported. PolTREG plans to publish these findings in a peer-reviewed journal.
PolTREG’s Treg therapy pipeline is one of the largest for autoimmune diseases. PTG-007 is currently in mid-stage clinical trials for T1D and multiple sclerosis, with upcoming studies planned for presymptomatic T1D and engineered CAR-Treg therapies for multiple sclerosis and amyotrophic lateral sclerosis.