PolTREG (WSE:PTG) has launched a Phase 2 clinical trial of PTG-007, a polyclonal autologous Treg cellular therapy, in children with presymptomatic Type-1 diabetes (T1D), following approval from the European Medicines Agency (EMA).
The study will assess the safety and efficacy of PTG-007 in 150 patients, aged 6 to 16, who are at high genetic risk of developing T1D but have yet to show symptoms. Clinical sites have begun opening, and patient recruitment and randomization are expected later this year.
“When patients are diagnosed with diabetes, they typically have already lost the vast majority of pancreatic islets producing insulin, and the rest will follow not much later. When administering PTG-007 at an earlier stage of the disease, the number of viable islets is still sufficient to prevent symptoms from occurring. This is why PolTREG believes diabetes can become a preventable disease, with patients never developing symptoms, and remaining clinically healthy,” said Prof. Piotr Trzonkowski, CEO of PolTREG.
PolTREG has received a grant of 31.7 million zloty (€7.3 million) from Poland’s Medical Research Agency to support the study. PolTREG holds up to 12 years of proprietary safety and efficacy data on patients with early-onset T1D treated with PTG-007.
