Dosing Begins in Clinical Study of YOLT-101 for FH Therapy

Dosing Begins in Clinical Study of YOLT-101 for FH Therapy

By, Admin 4 April 2024

Initial Dosing of Patient Commences in Clinical Study Investigating YOLT-101 for FH Therapy

Overview

YolTech Therapeutics has announced a significant milestone in its development of YOLT-101, an in vivo genome editing candidate for treating Familial Hypercholesterolemia (FH). The company has initiated an Investigator-Initiated Trial (IIT) by dosing the first patient with YOLT-101.

FH is a genetic disorder affecting the body's ability to remove low-density lipoprotein (LDL) cholesterol from the bloodstream, leading to an increased risk of early heart disease.

About YOLT-101

  • YOLT-101, developed independently by YolTech, targets specific genetic mutations associated with FH using advanced gene editing technology and lipid nanoparticle (LNP) delivery. 
  • Preclinical studies in non-human primate (NHP) models have shown significant and sustained reduction in LDL-C levels for nearly two years after a single dose.

About Trial

The clinical trial initiated by investigators is a single-arm, open-label, dose-escalation study. Its primary objectives include assessing the safety and tolerability of YOLT-101, determining the Optimal Biologically Active Dose (OBD), and preliminarily evaluating its impact on lipid and lipoprotein levels in FH patients.

YolTech Potential of YOLT-101

  • Dr. Yuxuan Wu, Founder and CEO of YolTech, expressed optimism about the potential of YOLT-101 to revolutionize treatment for FH patients. 
  • YolTech is committed to advancing the clinical development of YOLT-101 and collaborating closely with regulatory authorities, healthcare professionals, and patient advocacy groups.

YOLT-101 & Current Studies

  • YOLT-101 is an in vivo liver-based editing therapy designed to permanently deactivate the PCSK9 gene, thereby reducing disease-driving LDL-C levels. 
  • It is currently undergoing evaluation in the IIT clinical trial for patients with high-risk heterozygous FH, established atherosclerotic cardiovascular disease (ASCVD), and uncontrolled LDL-C levels on standard-of-care therapy.

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