An independent Data Monitoring Committee (DMC) has cleared the ELPIS II trial of laromestrocel (Lomecel-B) to proceed to completion without modification, following a final prespecified safety review that identified no new safety concerns in the fully enrolled Phase IIb study in hypoplastic left heart syndrome (HLHS).
Longeveron (Nasdaq: LGVN), a Miami-based clinical-stage biotechnology company, announced that the DMC conducted a risk-benefit assessment across all enrolled patients and recommended the study continue as designed. Top-line results are anticipated in August 2026, the company said.
The ELPIS II trial enrolled 40 pediatric patients across 12 pediatric cardiac centers in the US. The DMC review, described as the final planned independent safety assessment prior to trial completion, was based on available data for all participating patients. The committee indicated no safety concerns and approved continuation of the study. No efficacy data were reported at this stage, and the company did not disclose the trial's primary endpoint, dosing regimen, or blinding status in the announcement.
ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute through NIH grants. The trial builds on ELPIS I, an earlier study in which, according to Longeveron, treated children demonstrated 100% transplant-free survival up to five years of age. That figure applies to the predecessor study and should not be interpreted as an outcome from ELPIS II. The data from ELPIS II remain unreported, and the current update reflects a monitoring milestone rather than a clinical readout. Study design details, including whether the trial is randomized or controlled, were not specified in the announcement.