Longeveron Announces Topline Results from ELPIS II Phase 2b Clinical Trial Evaluating Laromestrocel as a Potential Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Longeveron's ELPIS II Phase 2b trial of laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome missed its primary endpoint, with a least-squares mean difference in right ventricular ejection fraction change at Month 12 of -0.7 percentage points (95% CI: -7.3 to 5.9; p=0.8336). Exploratory as-treated signals favored the treated arm — zero deaths over 12 months versus one in control and roughly 31% fewer adjudicated MACE (12 vs 19 events) — but these were not statistically significant, and the safety profile was consistent with prior trials with no new signals across 644 patients treated to date.
Key figures
- Drug Name
- laromestrocel
- Phase Of Trial
- Phase 2b
- Teae rate
- 94.1% laromestrocel vs 100% control
- Tesae rate
- 64.7% laromestrocel vs 71.4% control
- Mace events
- 12 treated vs 19 control (~31% fewer, not statistically significant)
- Deaths 12 month
- 0 in laromestrocel arm vs 1 in control (as-treated)
- Patients randomized
- 40
- Xprize grand prize max
- up to $81 million
- Xprize milestone award
- $1,000,000
- Primary endpoint result
- Missed — least-squares mean difference in RVEF change at Month 12 was -0.7 percentage points (95% CI: -7.3 to 5.9; p=0.8336)
- Transplant free survival events
- 1 of 17 laromestrocel vs 2 of 21 standard-of-care
- Patients treated across programs
- 644
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