PolTREG S.A. announced data demonstrating that its Treg cell therapy, PTG-007, led to clinical remission for up to 12 years in type-1 diabetes (T1D) patients. The data, presented at the INNODIA EASD symposium in Madrid, also showed that a subset of patients remained insulin-independent for up to 24 months post-treatment. These findings pave the way for a pivotal Phase II/III study of PTG-007.
The clinical study followed 54 patients with early-onset T1D who participated in Phase I and Phase II trials of PTG-007, monitoring them over a period of 7 to 12 years. The study defined clinical remission as a reduced need for external insulin while maintaining proper metabolic control.
Key Findings from the Study
- A proportion of patients treated with PTG-007 maintained insulin independence for 18-24 months.
- A subset of patients experienced clinical remission 7-12 years post-treatment.
- The most favorable outcomes were observed in patients receiving Treg therapy combined with rituximab, an anti-CD20 treatment, as indicated by their own insulin levels after consuming a standardized liquid meal.
- Analysis of over 700 variables related to heart function, microcirculation, kidney, liver, endocrine system, and fertility revealed no inferiority in patients treated with Treg cells compared to standard-of-care.
- The treatment showed no severe adverse effects.
PTG-007 and PolTREG's Pipeline
PTG-007, an autologous polyclonal Treg treatment, is currently in mid-stage clinical studies for T1D and multiple sclerosis (MS). PolTREG plans to launch a Phase 2 study in pre-symptomatic T1D patients later this year and expects to begin a first-in-human trial of its engineered CAR-Treg, utilizing the PTG-007 platform, for treating MS and amyotrophic lateral sclerosis (ALS) next year.
"People with type-1 diabetes understand the life-long commitment needed for their care. This is why the results of treating patients over such a long period with our cellular therapy PTG-007 is so important," said Prof Piotr Trzonkowski, CEO of PolTREG. "Today’s results are extremely encouraging, and show that some patients remain in clinical remission for up to 12 years after initial treatment."
Future Directions
PolTREG is working towards publishing the study in a peer-reviewed scientific journal. The company is also seeking partnership funding to launch a pivotal Phase 2/3 study of PTG-007 for T1D. The company also plans to start first-in-human trials evaluating the Treg therapy as a treatment for multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS).
With one of the largest and most advanced pipelines for Treg therapies, PolTREG is also developing both polyclonal and engineered therapies. The company's GMP-certified manufacturing facility allows for the production and distribution of its cell therapies across Europe.
