Longeveron ELPIS II trial misses primary efficacy endpoint in HLHS but shows favorable safety

Longeveron/Laromestrocel (Lomecel-B)

The 40-patient Phase 2b ELPIS II trial of laromestrocel as an adjunct to Stage 2 surgery in hypoplastic left heart syndrome did not meet its primary endpoint of improved right ventricular ejection fraction at 12 months. The therapy maintained a favorable safety profile with no deaths in the treatment arm versus one in control over 12 months.

• Primary endpoint missed: right ventricular ejection fraction change differed insignificantly (p=0.83)
• No treatment-related deaths; one control death recorded over 12 months
• Safety profile consistent across 644 patients treated in all Longeveron programs
• Company analyzing exploratory endpoints and evaluating regulatory strategy with FDA