CLEVELAND – June 15, 2020 – Diasome Pharmaceuticals, Inc., a company developing hepatocyte directed vesicle (HDV) technology that can be added to any commercially available insulin to prevent hypoglycemia for people living with diabetes, recently 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.

“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. Distinguished Service Professor and Division Chief of Endocrinology, Diabetes, and Metabolism in the Department of Medicine at SUNY Upstate Medical University and an investigator in the OPTI-1 clinical trial.“The major reduction in nighttime Level 2 hypoglycemic events, defined as longer than 15 minutes of continuous glucose monitor readings below 54 mg/dL,also seen during the treatment period is especially notable since overnight hypoglycemia risk in patients with type 1 diabetes is significant.”

Over the 90-day run in period 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-day period 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. Notably, the Level 2 hypoglycemic event reductions during treatment with HDV added to lispro were achieved despite a modest overall increase in mealtime insulin and total insulin dosing and without a negative impact on overall glucose control.  

Diasome’s chief scientific officer, W. Blair Geho, M.D., Ph.D., added, “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. We look forward to beginning Phase 3 trials in 2021 to evaluate HDV as an additive to insulin that physiologically prevents hypoglycemia.”

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.

About Hepatocyte Directed Vesicle (HDV) Technology

HDV is the most advanced technology 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.

About Type 1 Diabetes (T1D)

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.

Insulin-induced hypoglycemia is recognized as one of the most significant barriers to maintaining normal blood glucose control in patients on insulin therapy, and there are no currently approved mealtime insulin therapies that have been shown to prevent hypoglycemia. On average, about 20% of people with type 1 diabetes in the U.S. experience one or more severe hypoglycemic events per year. The average treatment cost of a single severe hypoglycemic event is estimated at more than $16,000, which translates into more than $5 billion in hypoglycemia treatment costs per year in the U.S., alone.*

About OPTI-1

The 24-week, open-label, multiple dose trial was 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.

About Diasome Pharmaceuticals, Inc.

Diasome’s hepatocyte directed vesicle (HDV)technology is the only pharmaceutical insulin additive being developed to prevent hypoglycemia by restoring normal liver physiology in patients with diabetes. HDV technology can be added to all forms of insulin to improve their safety and efficacy. For more information, visit www.diasome.com or follow us on Twitter.

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*“Modeling the Total Economic Value of Novel Type 1 Diabetes (T1D) Therapeutic Concepts,” a recent white paper by the JDRF