Diasome Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing hepatocyte directed vesicle (HDV) nanotechnology as an insulin additive to substantially improve blood glucose control for people living with diabetes, today issued a company update for the 16-month period ending December 2018.

The company has completed three human clinical studies of its HDV nanotechnology in patients with type 1 diabetes, including two Phase 2 studies and one Phase 2b study.

• Its Phase 2 “Good to Great” double-blinded, multi-center study compared injected HDV added to rapid acting insulin (lispro) versus lispro alone in 42 patients with baseline HbA1C levels between 6.9% and 7.9% over six weeks of dosing.
• Its Phase 2 "Insulin Pump” double-blinded crossover study compared injected HDV added to lispro versus lispro alone in seven subjects on continuous subcutaneous insulin infusion over three weeks of dosing per treatment.
• Its Phase 2b “InSulin Liver Effect” (ISLE-1) double-blinded, multicenter study included 176 patients and compared injected HDV added to lispro versus lispro alone over six months of dosing.

Detailed results from these studies are being prepared for peer review and will be issued in the coming months.

Robert Geho, chief executive officer of Diasome, commented, “Currently available insulins address how quickly insulin takes effect and for how long, but they fail to account for where the insulin is actually working, which is a key factor in normal glucose metabolism. We are the first to provide a mealtime insulin strategy that enables a more physiological response by delivering necessary amounts of insulin to the liver at the right time. Since the liver has the only cells capable of both storing and releasing glucose, delivering insulin there should allow people with diabetes to achieve stabilization of target glucose levels and avoid dangerously low blood glucose levels.”

Additionally, pursuant to its earlier announcement of funding in mid-2017, the company has received additional funding from both current and new investors. Proceeds are being used to continue the clinical development of HDV, including the initiation of a new Phase 2 dose optimization study called the OPTI-1 Study in subjects with type 1 diabetes. This study is scheduled to begin dosing patients during the first half of 2019.

Diasome’s HDV nanotechnology was the subject of five issued patents in 2018, including two in the United States, two in the European Union and one in India. These patents cover both composition of matter and use claims for HDV in both injectable and oral formulations, as well as the use of HDV as a stand-alone therapy for obesity.

Mr. Geho continued, “We are pleased to share this update on the development of our HDV nanotechnology, and our recent accomplishments highlight our commitment to dramatically reducing the burden of hypoglycemia in people using insulin. We look forward to sharing the results of the completed studies and to the initiation of the OPTI-1 Study in H1 2019 as we continue our work to provide better outcomes for people living with diabetes.”