Longeveron’s phase 2b clinical trial evaluating its mesenchymal stem cell therapy, laromestrocel, as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (HLHS), failed to meet its primary endpoint.
HLHS, rare congenital heart defect, are born with an underdeveloped left ventricle, which creates a life-threatening condition due to the heart’s inability to pump adequate amounts of blood throughout the body.
The ELPIS II trial did not meet its primary endpoint of improvement in right ventricular ejection fraction (RVEF) at month 12. According to the company, there were exploratory clinical endpoints that Longeveron is continuing to analyze and plans to discuss with the FDA to determine a potential path forward in HLHS. Laromestrocel has maintained what Longeveron believes is a favorable safety and tolerability profile consistent with prior clinical trials, now with 644 patients treated across Longeveron's multiple clinical programs.
The company is looking at all of its options to increase value for shareholders. It plans to hire an investment bank to advise it on what to do next. In the meantime, it plans to cut or control spending to preserve cash. For laromestrocel, the company is looking for investors, funding, or other ways to generate revenue so it can continue developing the drug for longevity and age-related frailty.
Laromestrocel is an allogeneic mesenchymal stem cell therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular and regenerative responses, and therefore broad potential applications across a spectrum of disease areas.
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