Nuevocor doses first patient in NVC-001 gene therapy trial for LMNA cardiomyopathy
Published in Biology, Drugs development & discovery.
October 8, 2026 — Nuevocor announced the first patient dosing in SUNBEAM-LMNA, a phase 1/2 study of NVC-001 in adults with LMNA-related dilated cardiomyopathy. The company also reported FDA Fast Track designation for the experimental treatment.
NVC-001 uses an AAV9 vector to deliver a dominant-negative SUN1 protein. It is designed to reduce mechanical forces transmitted to heart-cell nuclei, addressing nuclear instability associated with LMNA mutations.
The multicenter, open-label trial will evaluate a one-time intravenous infusion at three dose levels. Its primary objectives are safety and tolerability; additional measures include heart structure and function, arrhythmia burden and quality of life. The registry identifier is NCT07606274.
First dosing marks the start of human evaluation, rather than evidence of clinical benefit. The announcement provides no patient outcome results. Fast Track supports development and regulatory interactions but does not establish efficacy or grant marketing approval.
Source: Nuevocor announcement distributed by PR Newswire, October 8, 2026.