HDV reduces hypoglycemia in OPTI-1 trial

Diasome reports substantial reductions in Level 2 hypoglycemia events in its Phase 2b OPTI-1 study

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CLEVELANDOver the weekend, Diasome Pharmaceuticals, Inc. presented new positive data from its Phase 2b OPTI-1 clinical trial in people with type 1 diabetes (T1D) at the American Diabetes Association’s 80th Annual Scientific Sessions. Diasome has been developing hepatocyte directed vesicle (HDV) technology, which reportedly can be added to any commercially available insulin to prevent hypoglycemia for people living with diabetes.
“While people with type 1 diabetes may view their rapid-acting insulin as increasing their risk of hypoglycemia, we saw reductions in hypoglycemic events during the 90-day treatment period when patients received HDV added to lispro, supporting the conclusion that liver-targeted mealtime insulin has the potential to decrease time spent in hypoglycemia,” said Ruth Weinstock, M.D., Ph.D., who is Distinguished Service Professor and division chief of Endocrinology, Diabetes and Metabolism in the Department of Medicine at SUNY Upstate Medical University, as well as an investigator in the OPTI-1 clinical trial. “The major reduction in nighttime Level 2 hypoglycemic events … seen during the treatment period is especially notable since overnight hypoglycemia risk in patients with type 1 diabetes is significant.”
Th open-label, multicenter OPTI-1 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.
Over the 90 days when patients were treated with standard-of-care insulin therapy (lispro/degludec), Level 2 hypoglycemic events decreased by 10.8% over a 24-hour period. Daytime events decreased by 10.6% and nighttime events decreased by 20.9%. Mean baseline A1C decreased from 7.3% to 6.9% at the end of the randomization period.
During the second 90 days, when patients were treated with HDV added to lispro, patients experienced an additional 17.1% reduction in 24-hour events, a 6.7% reduction in daytime events and a 25.2% reduction in nighttime events. The Level 2 hypoglycemic event reductions were achieved despite a modest overall increase in mealtime insulin and total insulin dosing, and without a negative impact on overall glucose control. 
“In combination with the substantial Level 2 hypoglycemia reductions demonstrated in Diasome’s Phase 2b ISLE-1 trial, the Level 2 event reductions from the OPTI-1 trial provide further evidence that HDV added to insulin restores the role of the liver and enables it to act how it does in people without diabetes, preventing both hypo- and hyperglycemia by appropriately storing or releasing sugar in response to blood glucose levels. These two trials represent a significant technical achievement in modern insulin development, as they demonstrate that insulin directed to the liver at mealtime actually mitigates hypoglycemia,” added W. Blair Geho, M.D., Ph.D., chief scientific officer of Diasome. “We look forward to beginning Phase 3 trials in 2021 to evaluate HDV as an additive to insulin that physiologically prevents hypoglycemia.”

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