Discussion
T1D
DISEASE PROGRESSION, DISEASE, COMPLICATIONS
Since the discovery of insulin therapy over 100 years ago, there have been no major changes in the clinical management of T1D apart from technical improvements in, for example, insulin variants, continuous glucose monitoring, and insulin pumps. These technologies clearly facilitate the daily control of blood glucose for patients but have had no impact on the underlying cause of the disease nor on the prevention of further disease progression. To date, there is still an important unmet need for disease-modifying therapies that would help patients with T1D achieve optimal glycemic targets, halt disease progression, and prevent β-cell loss. In this report, we have presented the first-in-human study of Imotope™ technology previously shown to eliminate pathogenic autoreactive T cells in an antigen- and disease-specific manner while preserving general immune system function in animal models.The main focus of the study was safety. As T1D can be effectively controlled with insulin, clinical development of any novel treatments, including disease-modifying therapies, has to include a broad assessment of safety parameters to meet very stringent criteria before the treatment can enter clinical practice [Overall, the lack of differences observed in different clinical parameters was expected due to the small sample size and short duration of follow-up among an adult population, who are known to show slower disease progression [Insulin therapy transformed the treatment of T1D, however, it does not modify the underlying cause of the disease or prevent complications [This study has demonstrated an encouraging safety profile of IMCY-0098 for three dosages and with a dosing scheme including four administrations. Patients treated with IMCY-0098 dose C showed no deterioration and a tendency for a slight improvement in clinical parameters compared with the expected natural history of the disease, but the results from a larger, ongoing phase 2 study are needed to explore dosing regimens and make the final dosing decision. Future studies are also needed to fully elucidate the immune response and level of β-cell protection following treatment with IMCY-0098. As IMCY-0098 targets both DR3 and DR4, these HLA haplotypes being represented in 95% of the T1D population [Autoantibody levels have been discussed in the context of assessing disease severity in T1D [Limitations of this study include the small sample size and short duration of the study. There were also imbalances in cohort composition in regards to DR3