Diasome Pharmaceuticals Prepares HDV-Insulin Lispro Phase 3 Program in Type 1 Diabetes; New CMO Sangeeta Sawhney MD Following Phase 2b OPTI-2 25% Level 2 Hypoglycemia Reduction
Diasome Pharmaceuticals announced Tuesday September 15, 2026 the appointment of Sangeeta Sawhney MD as Chief Medical Officer to lead clinical development as the company advances HDV-Insulin (hepatocyte-directed vesicle-formulated insulin lispro) toward Phase 3 in type 1 diabetes. HDV-Insulin uses a proprietary phospholipid matrix that binds short-acting insulin (lispro) and preferentially directs it to the liver rather than the systemic circulation, more closely approximating the liver-first insulin delivery pattern in people without diabetes. The Phase 2b OPTI-2 trial (topline reported June 2026) documented HbA1c non-inferiority to standard lispro mealtime dosing plus a 25% reduction in Level 2 hypoglycemia (serious low blood sugar) and no severe hypoglycemia events over six months of mealtime dosing. The Phase 3 program is designed to prospectively confirm the hypoglycemia-reduction benefit alongside glycemic control non-inferiority in adults with type 1 diabetes on multiple daily injections or pump therapy. Insulin is a peptide hormone; HDV-Insulin is one of several liver-targeted insulin approaches in development to address the fundamental peripheral-versus-hepatic delivery mismatch that has driven hypoglycemia risk since injectable insulin's 1922 introduction. Trial design detail plus regulatory-pathway alignment with FDA are expected first half of 2027.