News and Press
Diasome Announces First Patient Enrolled in Phase 2 Study of Hepatocyte Directed Vesicle Nanotechnology for People with Type 1 Diabetes
CLEVELAND, March 28, 2019 (GLOBE NEWSWIRE) — Diasome Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing hepatocyte directed vesicle (HDV) nanotechnology that can be added to any insulin to substantially improve blood glucose control for people living with diabetes, today announced that the first subject has been enrolled in its Phase 2 “OPTI-1” study of injectable HDV plus insulin for the treatment of type 1 diabetes. This study is designed to optimize the ratio of long-acting to short-acting insulin therapies when using HDV.
“We are excited to announce enrollment in our OPTI-1 Phase 2 study, which is designed to provide additional dosing guidance based on recently analyzed Phase 2 and Phase 2b clinical data. This achievement highlights our commitment to significantly improving disease management and quality of life for people living with type 1 diabetes by the focused development our HDV nanotechnology,” said W. Blair Geho, M.D., Ph.D., chief scientific officer of Diasome.
Douglas Muchmore, M.D., chief technology officer of Diasome, said, “The OPTI-1 study has been designed in conjunction with recognized thought leaders, and we believe that its key features will provide us with further refinements toward optimal dosing of mealtime insulin when HDV is added. As the most clinically advanced developer of liver-targeted insulin in the industry, we continue to address where insulin goes after it is injected because of the critical importance of the liver in glucose metabolism.”
This open-label, multicenter study will evaluate the effect of HDV added to insulin on a variety of standard diabetes outcomes including HbA1c, hypoglycemia, and bolus and basal insulin dosing in adult type 1 diabetes subjects whose starting HbA1c levels are between 6.5% and 8.5%. Diasome intends to enroll approximately sixty participants who will undergo a three-month run-in period on standard of care therapy followed by three months of treatment with HDV plus insulin along with different long-acting insulin dosing rates.
About Diasome
Diasome Pharmaceuticals, Inc. is developing hepatocyte directed vesicle (HDV) nanotechnology as an insulin additive to substantially improve glucose control and reduce the burden of life-threatening hypoglycemia for people living with diabetes. Our HDV nanotechnology has the potential to improve the safety and efficacy of all insulins by restoring the liver’s natural role in glucose control. For more information, visit www.diasome.com.
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