Diasome to Present Phase 2b Results from OPTI-2 Trial Evaluating HDV-Insulin Lispro in Type 1 Diabetes at ADA 86th Scientific Sessions

Data from randomized, double-blind study in 226 adults to be presented as an oral abstract

CLEVELAND, May 26, 2026 (GLOBE NEWSWIRE) -- Diasome Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing portal-hepatic targeted therapies for metabolic disease, today announced that results from its OPTI-2 Phase 2b clinical trial will be featured as an oral presentation at the American Diabetes Association (ADA) 86th Scientific Sessions, taking place June 5–8, 2026, in New Orleans, Louisiana.

“For more than 30 years, people living with type 1 diabetes and their physicians have faced a fundamental tradeoff between achieving tighter glycemic control and increasing the risk of hypoglycemia,” said Robert Geho, Chief Executive Officer of Diasome. “We believe Diasome’s hepatocyte-directed insulin has the potential to help address that challenge by improving the way insulin is delivered and utilized in the body. We look forward to presenting the OPTI-2 data at ADA and discussing its potential implications for diabetes management.”

The oral presentation will take place during the following session:

Presentation Title: Hepatic-Directed Insulin Lispro (HDV-L) Reduces Hypoglycemia Risk in Adults with Type 1 Diabetes Compared with Insulin Lispro (OPTI-2 Study)
Abstract Number: 1256-OR
Session: Novel Approaches to Glucose Control (With ADA Presidents’ Select Abstract Presentation)
Presenter: Klara Klein, MD, PhD, Principal Investigator, Assistant Professor of Medicine, University of North Carolina School of Medicine UNC Chapel Hill
Date and Time: Sunday, June 7, 2026, 4:00–4:15 PM CT
Location: Ernest N. Morial Convention Center, New Orleans, LA


All data and results will be embargoed until 4:00 PM CT on Sunday, June 7, 2026.

About OPTI-2

OPTI-2 (NCT06238778) was a Phase 2b, double-blind, randomized, parallel-group study conducted at 27 sites in the United States. The trial enrolled 226 adults with type 1 diabetes on multiple daily injection (MDI) therapy and randomized participants 1:1 to bolus insulin with HDV-LIS or standard LIS, both with once-daily insulin degludec as basal insulin and continuous glucose monitoring (Dexcom G7) worn throughout the 25-week treatment period. The study included a 12-week dose optimization period with weekly CGM-guided titration, followed by a 13-week dose maintenance period.

About HDV-Insulin Lispro

HDV (hepatocyte-directed vesicle) is a phospholipid bilayer bicelle that binds standard insulin lispro and preferentially directs it to hepatocyte receptors, restoring a more physiologic pattern of hepatic insulin exposure. By restoring mealtime liver insulinization, HDV-LIS may improve postprandial glucose disposal and hepatic glycogen storage, reducing the frequency and severity of hypoglycemia. HDV-Insulin Lispro is an investigational therapy and has not been approved by the U.S. Food and Drug Administration.

About Diasome Pharmaceuticals

Diasome is a clinical-stage biopharmaceutical company developing therapies designed to act at the source of metabolic regulation. The company’s proprietary Hepatocyte-Directed Vesicle (HDV) platform targets liver hepatocytes and the portal hepatic region, where metabolic control begins, grounded in the principle that therapies working with the body’s natural physiology may produce improved outcomes. HDV is being applied across insulin, GLP-1, and serotonin programs, with its lead insulin program exploring the platform’s potential to improve outcomes without the tradeoffs that have defined insulin therapy for decades.

Contacts

Media & Investors:
Adam Silverstein
adam@scientpr.com


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