(HIP2B, Human proIslet Peptide)
BTI-410 is a non-insulin, human peptide therapeutic that stimulates the pathway that leads to the development of new insulin producing cells in the pancreas. The peptide is derived from the protein trigger that populates the pancreas with islet structures that contain insulin producing beta cells. The peptide has been shown to be well-tolerated with no adverse effects in type 2 diabetes patients and has been studied in two human clinical trials. In type 2 diabetes patients, mean fasting insulin levels increased in the treatment group instead of decreasing over the course of the study period as seen in the placebo group. A significant change in pre-hepatic insulin secretion rate was observed, as well as improvements in mean insulin concentrations as measured by GGI and IVGTT, including some that seemed to persist during the post- treatment period. Improvements in insulin secretion levels and improvements in control of insulin secretion under glucose challenge, which persist after treatment phase is complete, are key benefits of islet neogenesis as a mechanism.
Two 90-day clinical trials are being planned for the study of BTI-410: one 36 patient study in type 1 patients who area immunosuppressed after kidney transplant, and another 120 patient study in otherwise healthy type 2 diabetes patients. The endpoints will include measures of glucose control that include restoration of first phase insulin release, increased fasting insulin levels and significant lowering of HbA1c that persists long after the treatment phase is complete.
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