Diasome Pharmaceuticals to Present HDV-Insulin Phase 2b Clinical Data at EASD 2026 and Inaugural Breakthrough T1D Clinical & Research Congress
Presentations will highlight Phase 2b OPTI-2 findings demonstrating the potential of HDV-insulin lispro to maintain
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Presentations will highlight Phase 2b OPTI-2 findings demonstrating the potential of HDV-insulin lispro to maintain glycemic control while reducing hypoglycemia in adults with type 1 diabetes
New exposure-adjusted incidence rate (EAIR) analyses from the OPTI-2 study to be featured in an oral presentation at the Breakthrough T1D Clinical & Research Congress
CLEVELAND and BOSTON, Sept. 21, 2026 (GLOBE NEWSWIRE) — Diasome Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing liver-targeted therapies for metabolic disease, today announced upcoming scientific presentations at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD), being held September 28–October 2, 2026, in Milan, Italy, and the inaugural Breakthrough T1D Clinical & Research Congress, being held October 9–11, 2026, in Philadelphia.
The presentations will highlight findings from Diasome’s Phase 2b OPTI-2 (NCT06238778) study evaluating HDV-insulin lispro compared with standard insulin lispro in adults with type 1 diabetes (T1D). The EASD presentation will feature previously reported OPTI-2 findings suggesting that HDV-insulin lispro has the potential to maintain glycemic control while reducing clinically meaningful hypoglycemia. At the Breakthrough T1D Clinical & Research Congress, Diasome will present these findings together with new exposure-adjusted incidence rate (EAIR) analyses from the study.
“OPTI-2 was designed to address one of the fundamental challenges of insulin therapy: achieving effective glucose control without increasing the risk of hypoglycemia,” said Paul Strumph, M.D., Senior Medical Advisor at Diasome Pharmaceuticals. “We are pleased to have the opportunity to share these findings with the international diabetes community at EASD and to build upon them with new analyses at the inaugural Breakthrough T1D Clinical & Research Congress. Together, these data continue to strengthen our understanding of the potential for restoring the liver’s role in insulin action to improve outcomes for people living with type 1 diabetes.”
Details of the presentations are as follows:
62nd Annual Meeting of the European Association for the Study of Diabetes (EASD)
- Title: Hepatic-directed insulin lispro reduces hypoglycaemia risk in adults with type 1 diabetes compared to insulin lispro (OPTI-2 study)
- Presenter: John B. Buse, M.D., Ph.D., Director of the UNC Diabetes Care Center at the University of North Carolina School of Medicine
- Date: Friday, October 2, 2026
- Location: Milan, Italy
Breakthrough T1D Clinical & Research Congress
- Title: Hepatocyte-directed vesicle insulin lispro versus insulin lispro In adults with type 1 diabetes lowers hypoglycemia risk
- Presenter: Paul Strumph, M.D., Senior Medical Advisor at Diasome Pharmaceuticals
- Date: Saturday, October 10, 2026
- Location: Philadelphia, Pennsylvania
About OPTI-2
OPTI-2 (NCT06238778) was a 25-week, multicenter, randomized, double-blind Phase 2b study designed to evaluate whether HDV-insulin lispro could maintain glycemic control while reducing hypoglycemia compared with standard insulin lispro in adults with type 1 diabetes (T1D).
The study enrolled 226 adults using multiple daily injection (MDI) therapy across 27 sites in the United States. Participants were randomized 1:1 to receive mealtime HDV-insulin lispro or standard insulin lispro, both with once-daily insulin degludec as basal insulin. Participants used continuous glucose monitoring (Dexcom G7) throughout the study, which included a 12-week dose-optimization period with weekly CGM-guided titration followed by a 13-week dose-maintenance period.
HDV-insulin lispro is an investigational therapy and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.
About Diasome Pharmaceuticals
Diasome Pharmaceuticals is a clinical-stage biopharmaceutical company developing a pipeline of therapies designed to act in the liver, a central regulator of metabolism. The company’s proprietary hepatocyte-directed vesicle (HDV™) technology is designed to preferentially target medicines to the liver and portal-hepatic region, with the goal of restoring or enhancing important metabolic signaling pathways.
Diasome’s lead program, HDV-Insulin, is designed to restore the liver’s role in mealtime insulin action and improve the balance between glycemic control and hypoglycemia risk for people who require insulin therapy. The company is also applying its liver-targeted approach to additional metabolic pathways, including GLP-1 and serotonin.
For more information, visit Diasome.com and follow Diasome on LinkedIn and X.
Corporate Contact:
Karen Donovan
Diasome Pharmaceuticals
KDonovan@diasome.com
Media Contacts
Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
(646) 942-5604
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of HDV-insulin lispro to maintain glycemic control while reducing hypoglycemia, the therapeutic potential of Diasome’s HDV platform and pipeline programs, plans for future clinical development, and the anticipated presentation of data at scientific conferences. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others: the inherent uncertainty of clinical development, including whether results from earlier clinical studies will be predictive of results from future studies; the risk that ongoing or future clinical trials may not be completed on time or at all; the risk that data from clinical trials may not support regulatory approval or further development; the ability to obtain and maintain regulatory approvals; the availability of funding sufficient to support continued development; and general economic and market conditions. Diasome undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
