Recently, Diasome Pharmaceuticals announced positive results from its Phase 2 OPTI-1 study on the efficacy of its hepatocyte directed vesicle (HDV) technology for preventing low blood sugar in patients with type 1 diabetes. The study results showed that this liver-targeted insulin may allow patients to reduce the amount of time they spend in hypoglycemia by using HDV technology and optimizing their relative basal and mealtime insulin doses.
What is HDV?
HDV, or hepatocyte directed vesicles, are microscopic lipid discs that can be added in liquid form to any currently available insulin and direct that insulin to the liver, where it can help to regulate blood sugar. In healthy individuals, insulin is secreted and delivered first to the liver, which plays a critical role in blood glucose regulation. Without HDV technology, injected insulin rarely reaches the liver, likely resulting in more frequent highs and lows in the user.
Diasome’s hepatocyte directed vesicle (HDV) technology is the only pharmaceutical insulin additive being developed with the intent to prevent hypoglycemia by restoring normal liver physiology in patients with diabetes. HDV technology is a Phase 3-ready asset designed to improve the safety and efficacy of various insulin formulations.
One of the trial’s investigators, Bruce Bode, M.D., a diabetes specialist with Atlanta Diabetes Associates and clinical associate professor in the Department of Medicine at Emory University, said, “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. 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 study was designed to evaluate the effect of HDV added to rapid-acting mealtime insulin on HbA1c, hypoglycemia, and bolus and basal insulin dosing in adult type 1 diabetes patients with baseline hba1cs between 6.5% and 8.5%. Patients underwent a three-month 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 patients with type 1 diabetes were enrolled at eight trial sites across the United States. 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 study saw positive results for preventing low blood sugar in patients with type 1 diabetes. Liver-targeted insulin may allow patients to reduce the amount of time they spend in hypoglycemia by using HDV technology and optimizing their relative basal and mealtime insulin doses.
When Will This Insulin Become Available?
Diasome hopes to begin dosing patients in phase 3 no later than Q1 2021. Assuming the Phase 3 program takes 18-24 months to complete, the company hopes to file for approval in late 2022 or early 2023.
The Importance of This Study
Robert Geho, CEO of Diasome (who lives with type 1 himself), says, “The biggest benefit for patients who use HDV insulin should be that they will finally have an insulin therapy that actually prevents hypoglycemia. In people without diabetes, insulin from the pancreas enables two key things. First, it signals the liver’s hepatocytes to store 30% – 65% of ingested glucose during a meal, thereby preventing peripheral hyperglycemia. Then, the liver is entirely unique in the body because it is the only tissue in the body that can release stored glucose into the blood to prevent hypoglycemia. 100 years after insulin was discovered, all currently prescribed insulins still struggle to reach the liver after injection, and no insulin therapy today can enable this normal storage and release of glucose.”
Diasome’s HDV system is the world’s most advanced clinical stage system for fixing this basic and critically important gap in therapy.
Keep your eyes peeled for this exciting technology that may reach your pharmacy counter in the next few years!