Longeveron announces NHLBI funded phase 2 ELPIS II trial of Lomecel-B in hypoplastic left heart syndrome surpasses 50% enrollment threshold

Longeveron Inc., a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, 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.

“Surpassing the 50% enrollment threshold is a significant milestone for the trial and more importantly for HLHS patients who are in such critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication,” said Wa’el Hashad, chief executive officer of Longeveron. “We look forward to continuing to execute on our clinical program for Lomecel-B and to do all possible to expedite completing enrollment in the ELPIS II trial.”

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 Paediatric Disease, and Orphan Drug Designations from the US 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.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The company’s lead investigational product is Lomecel-B an allogeneic medicinal signalling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors.

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