Accepted IND application allows for development program to move directly to a Phase 2 pivotal registration clinical trial
Phase 2 clinical trial initiation anticipated in first half of 2026
Pediatric cardiomyopathies affect at least 100,000 children worldwide
Effective treatment options are limited, with nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM). The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial.
"We are gratified to advance laromestrocel into clinical development for pediatric dilated cardiomyopathy, a rare, progressive, life-threatening disease with no current effective treatment,” said Nataliya Agafonova, M.D., Chief Medical Officer of Longeveron. "With nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis, there is a tremendous need for novel approaches to treat this pediatric cardiovascular disease. Our development program in DCM reinforces Longeveron’s commitment to developing innovative stem cell therapies for rare diseases, particularly for cardiovascular conditions, where we believe laromestrocel may have significant potential to improve patients’ lives.”
Laromestrocel is a proprietary, scalable, allogeneic, investigational cellular therapy derived from mesenchymal stem cells (MSCs) with multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.
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