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Longeveron Announces Independent Data Monitoring Committee Positive Review and Recommendation to Complete Phase 2b Stem Cell Therapy Clinical Trial in Hypoplastic Left Heart Syndrome (HLHS)
Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated
About this update from Longeveron Inc.
[{"type":"text","content":"Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indicationDMC performed a risk-benefit assessment, identified no new safety concerns, and recommended continuation of the study as designed through completionThis review represents the final planned independent safety assessment prior to completion of the trialELPIS II top-line trial results anticipated in August 2026 MIAMI, May 11, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the independent Data Monitoring Committee (DMC) has completed its final prespecified data review for the ongoing, fully enrolled, Phase 2b clinical trial (ELPIS II) evaluating laromestrocel (Lomecel-B®) as a potential adjunct therapy for hypoplastic left heart syndrome (HLHS). The DMC based its review on available data for all participating patients enrolled. The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study to continue as designed to completion. “We are grateful to the members of the DMC for their effort and diligence in this review,” said Nataliya Agafonova, M.D., Chief Medical Officer at Longeveron. “Based on the scientific rationale supporting laromestrocel and the clinical data generated to date, we remain encouraged by the potential of our investigational therapy in HLHS. With our Phase 2b clinical trial for HLHS having achieved full enrollment last June, we continue to anticipate top-line trial results in August 2026 and look forward to sharing the data.” ELPIS II enrolled 40 pediatric patients at 12 leading pediatric cardiac centers across the country. The clinical trial is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH). ELPIS II builds on findings from ELPIS I study, in which treated children demonstrated 100% transplant-free survival up to five years of age. Published historical outcomes in HLHS populations have reported substantial mortality despite surgical palliation. The U.S. Food and Drug Administration (FDA) has granted laromestrocel Orphan Drug designation, Fast Track de...