Nuevocor Doses First Patient in SUNBEAM-LMNA Phase 1/2 Trial and Receives FDA Fast Track Designation for NVC-001 in LMNA Dilated Cardiomyopathy

NVC-001 is designed to target the mechanobiological root cause of LMNA dilated cardiomyopathy and has disease-modifying potential

SINGAPORE, PARIS and PHILADELPHIA, Oct. 8, 2026 /PRNewswire/ -- Nuevocor, a clinical-stage biotechnology company pioneering mechanobiology-targeted therapies designed to address the root causes of life-threatening cardiomyopathies, today 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. More information can be found at www.sunbeamstudy.com.

About LMNA Dilated Cardiomyopathy

LMNA DCM is caused by mutations in the LMNA gene, which encodes lamin A and C, the proteins that give the cell nucleus its structural stability. Without functional lamin, the nucleus cannot withstand the repetitive force of cardiac contraction, driving one of the most aggressive forms of dilated cardiomyopathy, characterized by early conduction disease and arrhythmias, a high risk of sudden cardiac death, and rapid progression to end-stage heart failure. LMNA DCM affects an estimated 100,000 people in the United States and Europe. There are no approved disease-modifying treatments, and heart transplantation remains the only option in advanced disease.

About NVC-001

NVC-001 is a first-in-class, one-time AAV9-based gene therapy encoding a dominant-negative form of the SUN1 protein, designed to reduce the forces transmitted to the cardiomyocyte nucleus and restore nuclear integrity, a hallmark defect in LMNA DCM. In preclinical studies, treatment with NVC-001 demonstrated improvements in survival and cardiac function, as well as a favorable safety profile. NVC-001 has received Fast Track designation from the FDA and is being evaluated in the SUNBEAM-LMNA Phase 1/2 trial.

About Fast Track Designation

Fast Track designation is intended to facilitate the development and expedite the review of investigational therapies for serious conditions that have the potential to address an unmet medical need. Benefits include more frequent interactions with the FDA and eligibility for Rolling Review, which allows completed portions of a Biologics License Application (BLA) to be submitted and reviewed before the entire application is complete. A product granted Fast Track designation may also be eligible for Priority Review and Accelerated Approval if the applicable criteria are met.

About Nuevocor

Nuevocor is a clinical-stage biotechnology company pioneering mechanobiology-targeted therapies designed to address the root causes of life-threatening genetic cardiomyopathies. Leveraging its proprietary PrOSIA platform, the Company is advancing a pipeline of therapies designed to target shared disease-driving pathways across multiple cardiomyopathies with the goal of modifying disease at its source. Nuevocor's lead clinical candidate, NVC-001, is being developed for LMNA-related dilated cardiomyopathy (LMNA DCM), one of the most aggressive forms of dilated cardiomyopathy.

In 2025, Nuevocor closed a US$50 million financing from Kurma Partners, Angelini Ventures, EDBI (an arm of SG Growth Capital, the investment platform of the Singapore Economic Development Board (EDB) and Enterprise Singapore), ClavystBio, Boehringer Ingelheim Venture Fund, Coronet Ventures and Highlight Capital. With operations spanning Singapore, the U.S., and Europe, Nuevocor brings together world-class scientific innovation and experienced drug development leadership working toward changing the trajectory of inherited heart disease for patients around the globe. For more information, visit www.nuevocor.com.

SOURCE Nuevocor