PolTREG S.A., a pioneering biotechnology firm specializing in cellular therapies for autoimmune disorders, has announced groundbreaking findings from its long-term clinical study on PTG-007, a polyclonal Treg cell therapy for early-onset type-1 diabetes (T1D). Over a span of 7 to 12 years, pediatric patients treated with PTG-007 demonstrated sustained insulin secretion, contrasting starkly with a control group receiving standard care.
The study, aimed at assessing both safety and efficacy, revealed that PTG-007 not only preserved insulin production but also extended periods of disease remission significantly beyond conventional treatments. According to initial estimates, patients experienced between 3 to 4 years longer in remission compared to those in the control cohort. Importantly, no significant health disparities were noted between the treated and untreated groups, underscoring the therapy’s safety profile over the long term.
Professor Piotr Trzonkowski, CEO of PolTREG, emphasized the study’s implications: “This long-term data reinforces our confidence in PTG-007’s efficacy, potentially alleviating the lifelong burden of type-1 diabetes management, including frequent insulin injections and associated complications.”
The study fulfills rigorous safety criteria set by the European Medicines Agency, positioning PolTREG ahead in demonstrating prolonged safety of Treg therapies post-administration. This achievement not only marks a significant competitive edge but also sets the stage for PolTREG’s forthcoming pivotal Phase 2/3 trial aimed at regulatory approval.
Looking forward, PolTREG plans to initiate Phase 2 trials later this year for presymptomatic patients, aiming to intervene early in the progression of T1D. Beyond diabetes, PolTREG’s robust pipeline includes advancing PTG-007 for multiple sclerosis (MS) and developing engineered Treg therapies for neurodegenerative diseases like MS and amyotrophic lateral sclerosis (ALS).
With a state-of-the-art GMP-certified manufacturing facility and a commitment to innovation, PolTREG continues to lead in the field of T-regulatory cell therapies globally. For more details on PolTREG and its transformative therapies, visit www.poltreg.com.
