Longeveron Announces Updated Results from ELPIS II Phase 2b Clinical Trial Evaluating Laromestrocel as a Potential Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Key Highlights
- ➤MACE: 8 events in standard care versus 1 with laromestrocel; P=0.043
- ➤ELPIS II missed primary Month 12 RVEF endpoint; p=0.68
- ➤Major cardiac events: 9 infants in standard care versus 3 with laromestrocel
- ➤Laromestrocel had no treatment-related serious adverse events through 12 months
- ➤Longeveron plans FDA meeting to discuss HLHS program next steps
ELPIS II 2 Data in HLHS Selected for Late-Breaking Science Program Podium Presentation in the American Heart Association’s (AHA) 2026 Scientific Sessions * As previously reported, the ELPIS II trial did not meet the primary endpoint of increase in right ventricular ejection fraction (RVEF) at month 12 and the Company planned to continue analysis of additional data * Additional analysis demonstrates an important pre-specified secondary clinical outcome endpoint, major adverse cardiac events (MACE), achieved statistical significance with 8 events in the standard of care arm versus 1 in the laromestrocel treatment arm (P=0.043) * Laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care arm * The Company believes the results suggest that laromestrocel may have the potential to meaningfully improve clinical outcomes of children with HLHS undergoing Stage II surgical palliation MIAMI, Oct. 26, 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 updated results from ELPIS II following planned additional analysis conducted by the Company and the National Institutes of Health (NIH) funded trial investigators. ELPIS II is the Company’s Phase 2b clinical trial evaluating its investigational stem cell therapy laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (HLHS).
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