Longeveron presents Lomecel-B long-term transplant-free survival data in HLHS

Longeveron (LGVN) announced that its positive long-term transplant-free survival data from a multi-year follow-on study to the ELPIS I Phase 1 clinical trial were featured in an oral presentation at the Congenital Heart Surgeons’ Society 51st Annual Meeting taking place October 27-28, 2024 in Chicago, Illinois. ELPIS I was an open-label, Phase 1 clinical trial designed to evaluate the safety of Lomecel-BTM in patients with HLHS. Patients underwent the Glenn Procedure at approximately 4-5 months of age. The results from the ELPIS I trial, which were previously reported, and published in the European Heart Journal Open in 2023, showed that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected rate of growth one year after treatment. To assess long-term survival benefits, all ELPIS I patients were followed for five years post-Glenn surgery and treatment with Lomecel-BTM to evaluate overall survival and transplant-free survival. Outcomes were compared with long-term historical data from patients in the Single Ventricle Reconstruction Trial receiving the same shunt type at Stage I operation and underwent Glenn procedures. Key findings include: 5-year post-Glenn procedure Kaplan-Meier survival was 100% in patients treated with Lomecel-B in ELPIS I, with none requiring heart transplant. This compared to 83% transplant-free survival in the SVR trial through 5 years post-Glenn surgery, and a 5.2% heart transplantation rate. No Major Adverse Cardiovascular Events were reported during the study. No Lomecel-BTM related safety issues were reported. These findings support the use of Lomecel-BTM as a potential adjunct to HLHS reconstruction surgery to improve transplant-free survival. ELPIS II is a Phase 2b randomized clinical trial further evaluating Lomecel-BTM, compared to standard of care, as a potential adjunct therapy for HLHS. ELPIS II is on-going and enrolling 38 pediatric patients at twelve premiere infant and children’s treatment institutions across the country. The clinical trial is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institutes of Health. ELPIS II builds on the positive clinical results of ELPIS I.