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Longeveron reports laromestrocel reduced MACE by 87% in HLHS Phase 2b trial, plans FDA meeting
LGVNLongeveron Inc.
Longeveron announced updated results from its ELPIS II Phase 2b clinical trial of laromestrocel for hypoplastic left heart syndrome (HLHS). While the primary endpoint was not met, a pre-specified secondary analysis showed statistical significance in major adverse cardiac events (MACE), with one event in the treatment arm versus eight in the standard of care arm (P=0.043). The company intends to request an FDA meeting to discuss next steps for its HLHS development program. Longeveron is a clinical-stage biotechnology company developing cellular therapies for rare pediatric and chronic aging-related conditions.