Clinical TrialMay 11, 2026, 09:12 AM
Longeveron's ELPIS II trial for HLHS cleared final safety review
AI Summary
Longeveron Inc. announced that the independent Data Monitoring Committee (DMC) completed its final prespecified data review for the fully enrolled Phase 2b clinical trial (ELPIS II) evaluating laromestrocel for hypoplastic left heart syndrome (HLHS). The DMC performed a risk-benefit assessment, identified no new safety concerns, and recommended the study continue as designed to completion. Top-line trial results are anticipated in August 2026.
Key Highlights
- DMC completed final prespecified data review for ELPIS II trial.
- DMC identified no new safety concerns for laromestrocel in HLHS.
- DMC recommended continuation of the ELPIS II study as designed.
- ELPIS II top-line trial results are anticipated in August 2026.
- ELPIS II enrolled 40 pediatric patients across 12 centers.
- Laromestrocel has Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS.
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