Longeveron Inc. announced the Phase 2 ELPIS II trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) and using the Company?s Lomecel-B? asset in Hypoplastic Left Heart Syndrome (HLHS), has surpassed the 50% enrollment threshold. Additionally, the trial has activated its eighth clinical site location ? one additional site beyond the seven originally planned -- in order to try to expedite the completion of the trial enrollment.

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow (blood circulation throughout the body), which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. While these children can now live into adulthood, early mortality is still extremely high in this population due to right ventricle failure, which is not meant for the increased load demanded by the systemic circulation.

As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes. ELPIS II (NCT04925024) is a 38-participant, randomized (1:1) blinded, controlled Phase 2 clinical trial evaluating the safety and efficacy of intramyocardial injection of Lomecel-B? in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. Lomecel-B? for HLHS has previously received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA).

ELPIS II is being funded by grants from the National Institutes of Health?s National Heart, Lung, and Blood Institute (NHLBI; Grant numbers UG3HL148318, U24HL148316), in collaboration with Longeveron.