Sernova Corp. provided a progress update on its Phase 1/2 T1D clinical trial in conjunction with Dr. Piotr Witkowski, the clinical trial's Principal Investigator at the University of Chicago. Dr. Witkowski was originally scheduled to provide a clinical trial update at the 2022 American Society of Transplant Surgeons (ASTS) Winter Symposium; however, the conference is now postponed until August 2022 as a result of the ongoing COVID-19 pandemic.

The objective of the company's Phase 1/2 clinical trial is to assess the safety, tolerability and efficacy of its proprietary Cell PouchTM transplanted with insulin-producing islets in patients with T1D complicated by hypoglycemia unawareness and a history of severe hypoglycemic events. Study patients must meet stringent eligibility criteria including, but not limited to, long-standing T1D, recent episodes of hypoglycemic unawareness and an absence of glucose-stimulated C-peptide detectable in their bloodstream. Study patients are eligible to receive up to three islet cell transplants throughout the study, including two marginal dose transplants into the Cell Pouch and a single, marginal islet supplement transplanted via the portal vein.

The company would like to highlight some updated study findings and key points from the ongoing trial: the ongoing safety and tolerability of Cell Pouch has been maintained in all study patients; Islet transplantation to the Cell Pouch resulted in the establishment of new, measurable islet function documented by detectable levels of stimulated C-peptide in the first three patients, who completed the protocol-defined course of transplants; a supplemental, single intraportal islet transplant was sufficient for the first two patients to achieve and maintain sustained ongoing insulin independence and freedom from severe hypoglycemic events for over 21 and 2 months, respectively; the third transplanted patient recently completed their course of Cell Pouch transplants and a supplemental intraportal islet infusion, with favorable improvements in glucose control, near-normal levels of C-peptide, an absence of severe hypoglycemic events and reductions in daily insulin use; the other three enrolled study patients are progressing through the study protocol, as planned. All have received Cell Pouch implants and are at various stages of protocol-defined islet transplants and follow-up; and a 7th study patient has been identified.