Diasome Presents Phase 2b Data Demonstrating HDV™-Insulin Lispro Maintains Glycemic Control While Reducing Hypoglycemia in Adults with Type 1 Diabetes

• HDV-Insulin Lispro (HDV-LIS) met A1C non-inferiority at Weeks 12 and 25, confirming comparable glycemic management to insulin lispro (LIS) with point-estimate variations beneath FDA-required 0.1% threshold
• HDV-LIS achieved statistically important reductions in steady glucose monitoring (CGM)-measured hypoglycemia throughout a number of endpoints throughout the upkeep interval
• Zero Degree 3 (extreme) hypoglycemic occasions with HDV-LIS vs. 5 with LIS
• Outcomes level to the potential of restoring mealtime liver insulin publicity to enhance the steadiness between glycemic management and hypoglycemia threat. Almost 2.1 million Individuals dwell with kind 1 diabetes¹ and annually, roughly 20% will expertise a extreme hypoglycemia occasion.^2,3
• Introduced as an oral presentation on the American Diabetes Affiliation (ADA) 86th Scientific Classes

NEW ORLEANS, June 07, 2026 (GLOBE NEWSWIRE) — Diasome Prescription drugs, Inc., a clinical-stage biopharmaceutical firm growing portal-hepatic focused therapies for metabolic illness, introduced Part 2b outcomes from OPTI-2, a doubtlessly groundbreaking 25-week, double-blind, randomized managed trial evaluating hepatocyte-directed vesicle insulin lispro (HDV-LIS) with commonplace insulin lispro (LIS) in 226 adults with kind 1 diabetes. In an oral presentation at the moment on the American Diabetes Affiliation (ADA) 86th Scientific Classes, Diasome reported that HDV-LIS maintained glycemic management with an A1C non-inferiority margin of <0.1% met at Weeks 12 and 25. CGM-measured hypoglycemia throughout the binary main endpoint interval (weeks 7-12) favored HDV-LIS in 14/15 endpoints however narrowly missed statistical significance. Throughout the subsequent 6 weeks of the research (upkeep interval), CGM-measured hypoglycemia with HDV-LIS reached statistical significance in a number of endpoints, together with >30% reductions in each Degree 2 hypoglycemic occasions (glucose <54 mg/dL for >15 consecutive minutes) and prolonged hypoglycemic occasions (glucose <70 mg/dL for larger than 2 consecutive hours). Total, CGM-measured hypoglycemia favored HDV-LIS in 47/51 endpoints within the trial. Zero HDV-LIS sufferers skilled a Degree 3 (extreme) hypoglycemic occasion, in contrast with 5 such occasions within the LIS group.

“Insulin remedy has all the time had a slender therapeutic index: tighter glycemic management immediately correlates with elevated threat of hypoglycemia. This tradeoff continues to be a significant problem for folks residing with kind 1 diabetes,” stated Klara Klein, MD, PhD, Assistant Professor of Medication, College of North Carolina College of Medication, and principal investigator within the trial. “In OPTI-2, we see potential to decouple glycemic management from hypoglycemia threat. Folks randomized to HDV-LIS met related A1C targets however skilled fewer hypoglycemic occasions and no extreme hypoglycemic occasions. If confirmed in bigger research, this might enable folks residing with T1D to attain glycemic targets with much less concern about clinically significant hypoglycemia.”

Hypoglycemia Threat in Kind 1 Diabetes

Hypoglycemia stays the central dose-limiting barrier in diabetes administration. Almost 2.1 million Individuals dwell with kind 1 diabetes.¹ Annually, about 20% of adults with kind 1 diabetes report not less than one extreme hypoglycemic occasion, a charge that persists even amongst customers of essentially the most superior automated insulin supply programs.^2,3 With commonplace insulin remedy, tighter glycemic management has been persistently related to elevated hypoglycemia threat—a coupling acknowledged for the reason that Diabetes Management and Problems Trial (DCCT) in 1993. OPTI-2 stands out as the first managed rapid-acting insulin trial to indicate A1C non-inferiority whereas concurrently demonstrating statistically important reductions in clinically significant hypoglycemia.

HDV™-Insulin Lispro

HDV (hepatocyte-directed vesicle) is a phospholipid bilayer bicelle that binds commonplace insulin lispro and preferentially directs it to hepatocyte receptors, restoring a extra physiologic sample of hepatic insulin publicity. By restoring mealtime liver insulinization, HDV-LIS could enhance postprandial glucose disposal and hepatic glycogen storage, doubtlessly decreasing the frequency and severity of hypoglycemia.

Examine Design

OPTI-2 enrolled 226 adults with kind 1 diabetes throughout 27 U.S. websites and randomized them 1:1 to HDV-LIS or LIS, with unblinded steady glucose monitoring (Dexcom G7) offered to each teams all through the research. The trial comprised a 12-week dose optimization interval with weekly insulin titration towards intensive glycemic targets, adopted by a 13-week upkeep interval with steady dosing. The prespecified main endpoint was a binary composite assessed throughout dose optimization requiring each A1C non-inferiority and superiority in not less than one in every of three nocturnal CGM-derived hypoglycemia metrics. The design had not been beforehand utilized in a blinded insulin trial. Prespecified secondary endpoints assessed the identical and extra hypoglycemia metrics throughout the first and final six weeks of the upkeep interval.

Outcomes

A1C non-inferiority was confirmed at Week 12 (HDV-LIS: -0.34% vs. LIS: -0.42%; estimated distinction 0.08%; [95% CI: -0.06, 0.21]; p=0.26) and Week 25 (HDV-LIS: -0.31% vs. LIS: -0.38%; estimated distinction 0.07%; [95% CI: -0.10, 0.25]; p=0.40), assembly the FDA’s required <0.1% A1C point-estimate distinction at each timepoints.

At Week 12, 14/15 prespecified CGM hypoglycemia level estimates favored HDV-LIS and met non-inferiority; nonetheless, statistically important superiority was narrowly missed throughout the 12-week window of energetic titration. Throughout the upkeep interval, the FDA’s most well-liked time for assessing hypoglycemia information, the HDV-LIS hypoglycemia threat discount sign strengthened significantly. HDV-LIS produced statistically important reductions throughout a number of prespecified secondary endpoints all through this era:

• 24-hour Degree 2 occasions: 28% discount (charge ratio 0.72; p=0.014)
• Daytime Degree 2 hypoglycemic occasions: 33% discount (charge ratio 0.67; p=0.009)
• 24-hour % time beneath 54 mg/dL: 28% discount (charge ratio 0.72; p=0.017)
• Daytime % time beneath 54 mg/dL: 32% discount (charge ratio 0.68; p=0.010)
• 24-hour prolonged hypoglycemia occasions: 36% discount (charge ratio 0.64; p=0.029)

Throughout the total research, the exposure-adjusted incidence charge of Degree 2 hypoglycemia was 25% decrease with HDV-LIS than with LIS, and nil HDV-LIS-treated members skilled a Degree 3 extreme hypoglycemic occasion, in contrast with 5 within the LIS group (p=0.0598).

Therapy-emergent opposed occasions had been comparable between teams (53.6% HDV-LIS vs. 50.0% LIS). Critical treatment-emergent opposed occasions occurred in a single HDV-LIS participant (0.9%) and eight LIS members (7.0%). No deaths, diabetic ketoacidosis occasions, or clinically significant hepatic security alerts had been noticed in both group.

“OPTI-2 demonstrated that HDV-LIS can doubtlessly break the tradeoff between tight glycemic management and hypoglycemia threat, with no extreme hypoglycemic occasions in six months of mealtime dosing and a 25% discount in Degree 2 hypoglycemia throughout the total research. These outcomes, mixed with A1C non-inferiority – the FDA’s most well-liked endpoint – now demonstrated in two consecutive blinded trials, give us clear assist to advance this system into Part 3,” stated Robert Geho, Chief Government Officer of Diasome. “We additionally imagine the HDV platform has broader potential, with the identical liver-targeting method being explored in metabolic illness and weight problems, the place focused hepatic supply could meaningfully enhance medical outcomes.”

About OPTI-2

OPTI-2 (NCT06238778) was a Part 2b, double-blind, randomized, parallel-group research performed at 27 websites in america. The trial enrolled 226 adults with kind 1 diabetes on a number of day by day injection (MDI) remedy and randomized members 1:1 to bolus insulin with HDV-LIS or commonplace LIS, each with once-daily insulin degludec as basal insulin and steady glucose monitoring (Dexcom G7) worn all through the 25-week therapy interval. The research included a 12-week dose optimization interval with weekly CGM-guided titration, adopted by a 13-week dose upkeep interval.

About Diasome Prescription drugs

Diasome is a clinical-stage biopharmaceutical firm growing therapies to behave within the portal-hepatic area, the middle of metabolic regulation. The corporate’s proprietary HDV™ platform delivers therapeutics preferentially to the liver and portal vein.  Diasome is making use of HDV throughout insulin, GLP-1, and serotonin packages. Diasome’s lead program, HDV-Insulin, is designed to decouple improved glycemic management from the elevated hypoglycemia threat that usually accompanies this important medication for tens of millions of sufferers globally. For extra details about Diasome, go to Diasome.com or observe us on LinkedIn or X. 

Contacts

Media & Buyers:
Adam Silverstein
adam@scientpr.com

¹ Facilities for Illness Management and Prevention. Nationwide Diabetes Statistics Report web site. https://www.cdc.gov/diabetes/php/data-research/index.html.
² Sherr JL, et al. Extreme hypoglycemia and impaired consciousness of hypoglycemia persist in folks with kind 1 diabetes regardless of use of diabetes expertise: outcomes from a cross-sectional survey. Diabetes Care. 2024;47(6):941–947. doi:10.2337/dc23-1765.
³ Sherr JL, et al. Persistent burden of extreme hypoglycemia and impaired consciousness of hypoglycemia amongst folks with kind 1 diabetes regardless of expertise use: a follow-up survey. Diabetes Care. 2026 Feb 26:dc25-2345. doi:10.2337/dc25-2345.

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