Workflow
Sernova Biotherapeutics Provides Positive Interim Data from Ongoing Phase 1/2 Clinical Trial of Cell Pouch Bio-hybrid Organ in Patients Living with Type 1 Diabetes

Core Insights - Sernova Biotherapeutics announced positive interim data from its Phase 1/2 clinical trial for its Cell Pouch Bio-hybrid Organ aimed at treating type 1 diabetes (T1D) [1][2] Group 1: Clinical Trial Results - Interim data from 12 patients show that 8 achieved insulin independence, with islet cell engraftment and improved glycemic control [2][3] - 7 out of 12 patients demonstrated C-peptide levels of 0.3 ng/mL or greater, indicating successful islet cell engraftment [4] - 9 of 12 patients had HbA1c levels below the ADA recommended threshold of <7.0%, with one patient showing a 24% reduction in HbA1c from 10.3% to 7.8% [5] Group 2: Patient Quality of Life Improvements - 11 of 12 patients reported improved awareness of hypoglycemia and increased sensitivity to severe hypoglycemic symptoms [7] - 10 of 12 patients showed a reduction in fear of hypoglycemia as measured by the Hypoglycemia Fear Survey-II [8] - 10 of 12 patients experienced a decrease in diabetes distress, indicating improved emotional well-being related to managing T1D [9] Group 3: Future Developments - Clinical trials with iPSC islet-like clusters from Evotec are expected to begin in 2026 after the completion of Cohort C [3] - The study is on track to meet its primary and secondary endpoints, with Cohort C anticipated to initiate in the second half of 2025 [2][10] - The Cell Pouch Bio-hybrid Organ is positioned as a potential functional cure for T1D, combining human donor cells or stem-cell derived islet-like clusters [11]