Longeveron Announces Updated Results from ELPIS II Phase 2b Clinical Trial Evaluating Laromestrocel as a Potential Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Longeveron announced updated Phase 2b ELPIS II results for laromestrocel in hypoplastic left heart syndrome: the trial missed its primary endpoint of right ventricular ejection fraction improvement at 12 months (p=0.68). However, the pre-specified secondary endpoint of major adverse cardiac events achieved statistical significance, with 8 events in the standard-of-care arm versus 1 in the laromestrocel arm (P=0.043), and no treatment-related serious adverse events were identified.
Key figures
- Drug Name
- laromestrocel (Lomecel-B)
- Phase Of Trial
- Phase 2b
- Deaths soc
- 1
- Mace p value
- 0.043
- Mace events soc
- 8
- Deaths treatment
- 0
- Trial enrollment
- 40
- Mace events treatment
- 1
- Primary endpoint p value
- 0.68
- Total major cardiac events soc
- 22
- Total major cardiac events treatment
- 3
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