Nuevocor Receives FDA Clearance for IND Application of NVC-001 for dialted cardiomyopathy

Nuevocor Receives FDA Clearance for IND Application of NVC-001 for dialted cardiomyopathy

By, Admin 12 June 2025

Overview

Nuevocor has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for NVC-001.

About NVC-001

  • NVC-001 is an adeno-associated virus (AAV)-based gene therapy and is the first treatment of its kind aimed at addressing the root mechanobiological cause of LMNA DCM. 
  • The company plans to start a Phase 1/2 clinical trial, which will be an open-label, dose-escalation study involving adult patients with the condition.

About the condition: LMNA DCM

  • LMNA DCM is caused by mutations in the LMNA gene, which encodes the lamin A/C protein. 
  • This protein plays a crucial role in maintaining the nuclear envelope and regulating gene activity in heart cells. 
  • Damage caused by these mutations can lead to weakening of the heart, irregular heartbeats, and eventual heart failure. 
  • The condition affects around 100,000 people across the United States and Europe.

The therapy target- The therapy is designed to treat LMNA-related dilated cardiomyopathy (LMNA DCM), a rare genetic condition that affects the heart muscle.

NVC-001 efficacy

  • NVC-001 has been developed to reduce mechanical stress on the cell nucleus and restore nuclear envelope stability, which is often disrupted in individuals with LMNA DCM. 
  • In preclinical studies, the treatment showed positive results, including improved heart function and survival.
  • NVC-001 will be delivered as a single intravenous infusion across different dosage groups.

The upcoming trial

The upcoming 52-week clinical trial will be conducted at multiple centres and will assess the safety, tolerability, and early effectiveness of the therapy.

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