Diasome Pharmaceuticals announced positive results from its Phase 2 OPTI-1 study of injectable hepatocyte directed vesicle (HDV) added to mealtime insulin in people with type 1 diabetes (T1D).

"The OPTI-1 study may be the first clinical trial to demonstrate the impact of the combined effects of liver targeted insulin and physiologically driven changes in the ratio of mealtime to long-acting insulin regimens," trial investigator, Bruce Bode, M.D., a diabetes specialist with Atlanta Diabetes Associates and clinical associate professor in the Department of Medicine at Emory University, said. "These results provide additional evidence that targeting insulin to the liver induces a more physiological response. When added to insulin, HDV may allow patients to optimize the amount of short-acting and long-acting insulin they need to reduce the incidence of hypoglycemia while still achieving positive long-term health outcomes."

This open-label, multicenter study was designed to evaluate the effect of HDV added to rapid-acting mealtime insulin on A1C, hypoglycemia, and bolus and basal insulin dosing in adult T1D patients with baseline A1C levels between 6.5% and 8.5%. Patients underwent a three-month run-in period on standard-of-care therapy followed by three months of treatment with HDV added to mealtime insulin in conjunction with optimized basal insulin doses. A total of 61 T1D patients were enrolled at eight United States trial sites. After patients were treated with standard-of-care Lispro or Degludec during the run-in period, they were randomized into one of two groups: HDV-Lispro (HDV-L) in conjunction with a 10% reduction in Degludec or HDV-L in conjunction with a 40% reduction in Degludec.

"The completion of this clinical trial marks an important milestone for the continued development of HDV," said Robert Geho, chief executive officer of Diasome. "Results from this study, which we plan to present at upcoming conferences, continue to support the hypothesis that improved mealtime insulin delivery to the liver should have an important and positive effect on overall glycemic control. We are excited about these results and look forward to sharing additional details soon."

HDVs are designed to restore normal physiology and potentially offer protection against hypoglycemia for patients with diabetes. Only 20-50 nanometers in size, these two-layered microscopic discs are designed to bring insulin to receptors highly expressed by liver cells. Liquid HDV can be mixed with any commercially available insulin prior to administration and is compatible with any insulin delivery system.

T1D is a chronic, auto-immune disease characterized by the inability of the pancreas to produce insulin, which leads to elevated blood sugar levels. Diabetes costs represent a large burden to both patients and the healthcare system. More than 1.25 million Americans are living with T1D and there is no cure.

The 24-week, open-label, multiple dose trial is designed to assess the safety, tolerability and efficacy of hepatocyte directed vesicle (HDV) technology when added to rapid-acting mealtime insulin. All patients received insulin Lispro and Degludec during a 12-week run-in period. After completing the run-in period, patients were randomized to a treatment group of either HDV added to Lispro (HDV-L) while continuing Degludec at a dose reduced by 40% or HDV-L while continuing Degludec at a dose reduced by 10% for 12 weeks of treatment.

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