New Immune Therapies Show Promise in Early Type 1 Diabetes Trials

Two experimental treatments are being tested to slow or prevent beta cell damage in people with newly diagnosed Type 1 diabetes. Early results suggest these approaches may be safer and better tolerated than previously available options.

Video report, corroborated with 2 indexed studies

Evidence label explains the kind of source behind this article (for example peer-reviewed literature vs community video). It is not medical advice.

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Key takeaways

AG019, an oral therapy made from modified bacteria that express insulin, is being tested alone and combined with teplizumab in people aged 12–42 with recent-onset Type 1 diabetes.
CNP-103, an intravenous immune therapy from COUR Pharma, is also in early-stage human trials for Type 1 diabetes.
These trials focus on safety, tolerability, and whether the treatments can preserve remaining beta cell function in the first months after diagnosis.
Type 1 diabetes develops differently in different people depending on genetics, immune system activity, and other factors—research is increasingly focused on matching treatments to individual disease patterns.

Understanding Two New Experimental Approaches

Two new immune therapies are entering human trials to test whether they can protect insulin-producing beta cells early in Type 1 diabetes. AG019, developed as an oral medication, uses food-grade bacteria that have been genetically modified to produce human proinsulin and a tolerizing immune signaling molecule called IL-10. The theory is that delivering insulin antigen through the gut—where the immune system is naturally more tolerant—could teach the body to stop attacking its own beta cells.

A second approach, CNP-103, takes a different route: it is delivered intravenously and represents another type of immune modulation strategy. Both are being tested in recent-onset Type 1 diabetes, when there may be the best opportunity to slow or halt beta cell loss.

What the AG019 Trials Are Testing

Researchers enrolled 42 people aged 12 to 42 years who had been diagnosed with Type 1 diabetes within 150 days. Half received AG019 alone in an open-label Phase 1b trial, meaning everyone knew they were receiving the treatment. The other half participated in a double-blind Phase 2a trial in which AG019 was given alongside teplizumab, an established immune therapy that delays diabetes onset.

The primary goal was to confirm that the treatment is safe and well tolerated over at least six months. Secondary goals included measuring whether AG019 could be detected in the bloodstream and stool, and whether it had any effect on immune markers or remaining beta cell function measured by C-peptide levels, blood sugar control, and insulin requirements.

Why Type 1 Diabetes Is Not One-Size-Fits-All

A major theme in recent Type 1 diabetes research is recognizing that the disease does not develop the same way in every person. Genetic susceptibility, immune system characteristics, and metabolic patterns vary widely. Some people with high genetic risk never develop diabetes, while others progress rapidly. This variation has important implications for treatment.

An international expert forum in 2024 highlighted that understanding this heterogeneity could enable personalized medicine approaches—matching specific immune therapies to the particular immune and genetic profile of each person. Researchers are also investigating disease-modifying immunotherapies and, in some cases, islet cell replacement as potential interventions tailored to individual disease patterns.

What These Trials Mean for the Type 1 Diabetes Community

These early trials are investigating whether newer immune strategies can preserve beta cell function in the critical window after diagnosis. Safety and tolerability are being prioritized; the focus is on confirming these treatments do not cause unintended harm and that people can tolerate them without stopping.

It is important to note that these are Phase 1b and Phase 2a trials—early-stage research. Results will need to be confirmed in larger Phase 3 trials before any therapy becomes available to patients. For people and families dealing with recent-onset Type 1 diabetes, these studies represent ongoing scientific effort to develop treatments that could eventually reduce the burden of managing the disease.

Evidence label

Origin: T1D Pulse (Video report). Evidence: Video report, corroborated with 2 indexed studies. Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.

Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.

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