Publications

Subcutaneous VRDN-003 vs Veligrotug (VRDN-001), Full Antagonist Monoclonal Antibodies to IGF-1R for Thyroid Eye Disease (TED): Phase 1 Safety/PK/PD Studies in Healthy Volunteers

Annual Meeting of The American Academy of Ophthalmology | October 2024

Introduction (truncated)

  • VRDN-003 is a next-generation monoclonal antibody that has the same binding domain as veligrotug
    (VRDN-001) with half-life extension to optimize SC dosing
  • Prior phase 2 proof-of-concept results showed 2 IV infusions of veligrotug were generally well tolerated with clinical activity in active and chronic TED
  • Recent topline data from THRIVE, a phase 3 study of veligrotug in active TED, showed:- 5 IV infusions of 10 mg/kg veligrotug administered Q3W led to significant and clinically meaningful improvements in TED symptoms at 15 weeks and were generally well tolerated – The primary and all secondary endpoints were statistically significant (p < 0.0001)- Veligrotug was generally well-tolerated, with no treatment-related SAEs and low (5.5%) placeboadjusted rate of hearing impairment AEs
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