PolTREG S.A., a biotechnology company specializing in cellular therapies for autoimmune diseases, has commenced a Phase 2 clinical trial of its PTG-007 Treg cell therapy in children with presymptomatic type 1 diabetes (T1D). The trial, initiated after receiving approval from the European Medicines Agency, aims to evaluate the safety and efficacy of PTG-007 in preventing the onset of symptomatic diabetes in high-risk individuals.
The study will enroll 150 patients between the ages of 6 and 16 who have a high genetic predisposition for developing T1D but have not yet exhibited any clinical symptoms of the disease. Clinical sites are being established, with patient recruitment and randomization scheduled to begin later this year. The trial is placebo-controlled.
Potential for Functional Cure
Prof. Piotr Trzonkowski, CEO of PolTREG, stated, "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."
Prior Data and Funding
PolTREG has secured a grant of 31.7 million zloty (€7.3 million) from Poland’s Medical Research Agency to support the trial. The company possesses up to 12 years of proprietary safety and efficacy data for PTG-007 in patients with early-onset T1D. These data indicate that a subset of patients remained insulin-independent for up to 18 to 24 months following treatment, while another group experienced clinical remission, characterized by a reduced need for external insulin, for 7 to 12 years after treatment.
PTG-007: An ATMP Platform
PTG-007, classified as an Advanced Therapy Medicinal Product (ATMP), serves as a platform for developing therapies targeting a range of autoimmune disorders. PolTREG has previously completed five clinical trials involving PTG-007 in T1D, multiple sclerosis (MS), and graft-versus-host disease. The company is also developing CAR-Treg and other engineered Treg cells. PolTREG is planning to launch a pivotal Phase 2/3 trial with PTG-007 in early-onset T1D, for which it is looking for external funding.
