Longeveron announces publication of final data from ELPIS I trial

Longeveron announced the publication of the full results from the Company’s ELPIS I trial of Lomecel-BTM for hypoplastic left heart syndrome in the European Heart Journal Open. In the uncontrolled open-label Phase 1b study entitled "Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial," patients underwent the Glenn Procedure at approximately 4-5 months old, and received intracardiac injections of Lomecel-BTM. The ELPIS I study was conducted by a consortium of leading pediatric cardiac surgeons led by Sunjay Kaushal, M.D., Ph.D., currently Division Head of Cardiovascular-Thoracic Surgery at Lurie Children’s and principal investigator of the ELPIS I study. The findings of the study included: None of the children experienced the prespecified safety endpoint over one year of follow-up. The procedure was generally well-tolerated in all ten study participants. The babies maintained their weight-for-age z-score after the surgery, and all were alive and transplant-free one year following the procedure. Several indices of right ventricular function, notably the tricuspid regurgitation fraction, showed suggestions of either improvement or prevention of deterioration over one-year following the surgery. In a sub-study of 6 babies, a blood test showed evidence of the persistence and activity of Lomecel-BTM one week after injection. Longeveron is currently enrolling patients in the ELPIS II trial, a 38-patient, randomized, blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-BTM in infants with HLHS who are undergoing the Glenn Procedure. This ongoing trial is funded by a grant from the National Heart, Lung, and Blood Institute. Lomecel-BTM for HLHS has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration.