Longeveron reports MACE benefit in ELPIS II trial despite missed primary endpoint
Longeveron said a secondary analysis of its Phase 2b HLHS trial found fewer major cardiac events with laromestrocel, though the study still missed its primary heart-function goal.
Longeveron Inc. announced on October 26, 2026 updated results from its ELPIS II Phase 2b trial testing laromestrocel in infants with hypoplastic left heart syndrome (HLHS), following additional analysis conducted with National Institutes of Health-funded investigators. ELPIS II tested laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with HLHS, and the study did not meet its primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12.1
Among a subset of 28 infants with both baseline and Month 12 cardiac MRI data, mean RVEF fell by 2.6 percentage points in the standard-of-care group and 3.3 percentage points in the laromestrocel group, a difference the company said was not statistically significant (p=0.68).1
On a secondary measure, however, the company reported a different picture. A review of the pre-specified secondary endpoint of major adverse cardiac events (MACE) found statistical significance, with 8 events in the standard-of-care arm compared with 1 in the laromestrocel arm (P=0.043).1 The company said laromestrocel was linked to fewer adjudicated clinical and safety events than standard of care, with a favorable safety profile through 12 months and no treatment-related serious adverse events identified.1
Longeveron said it believes these secondary endpoint findings suggest laromestrocel could help improve clinical outcomes for children with HLHS undergoing Stage II surgical palliation.1 The company plans to request a meeting with the FDA to discuss the results and determine next steps for the HLHS program.1
The ELPIS II data have been selected for a Late-Breaking Science Program podium presentation at the American Heart Association's 2026 Scientific Sessions in Chicago, running November 6-9, 2026.1 Longeveron noted that the FDA has previously advised the company that RVEF alone would not be sufficient to demonstrate efficacy for regulatory approval.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.