Nuevocor, a clinical-stage biotechnology company pioneering mechanobiology-targeted therapies designed to address the root causes of life-threatening cardiomyopathies, announced that the first patient has been dosed in SUNBEAM-LMNA, its first-in-human Phase 1/2 clinical trial evaluating lead asset NVC-001 in adults with LMNA dilated cardiomyopathy (LMNA DCM). Nuevocor also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NVC-001 for the treatment of LMNA DCM, one of the most aggressive forms of inherited heart disease, for which there are no approved disease-modifying therapies.

"Dosing the first patient in SUNBEAM-LMNA is an important milestone for Nuevocor. It brings us closer to a potentially transformational treatment for patients living with LMNA DCM and marks the first step toward validating mechanobiology as a new therapeutic approach in cardiovascular medicine," said Al Gianchetti, Chief Executive Officer of Nuevocor. "Fast Track designation reflects the seriousness of this disease and the potential for NVC-001 to address the high unmet needs of patients.

"LMNA DCM is a devastating disease with an urgent need for new treatment options. We believe NVC-001 has the potential to alter the course of the disease," said Monica Shah, MD, FACC, Chief Medical Officer of Nuevocor. "We are deeply grateful to the patients, families, investigators and site teams whose commitment and partnership are critical to advancing clinical research in LMNA DCM."

"This milestone represents the culmination of an extensive collaboration and underscores our commitment to bringing innovative therapies to patients facing the most complex and previously untreatable conditions," said Evan Kransdorf, MD, PhD, principal investigator for the trial and Assistant Professor of Cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles.

SUNBEAM-LMNA (NCT07606274) is a multi-center, open-label, single ascending dose Phase 1/2 trial evaluating a one-time intravenous infusion of NVC-001, a novel gene therapy, at three dose levels in adults with LMNA DCM. The primary objective of the trial is to evaluate the safety and tolerability of NVC-001. Secondary objectives include assessment of cardiac structure and function, arrhythmia burden, and quality of life.