Path Forward For Viridian’s IGF-1R Antibody In Chronic TED Raises Questions

Pivotal Trial Amendment Controversial

 
• By Ayisha Sharma
  
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The US firm’s potential rival to Horizon’s Tepezza, VRDN-001, showed positive signals in a small group of patients with chronic thyroid eye disease in a Phase I/II trial, but its decision to drop one planned dosing regimen from an upcoming pivotal trial has put off some analysts.  

bulging eye
TED Causes Double Vision, Pain And Proptosis (Bulging Eyes) • Source: Shutterstock

Key Takeaways:

  • VRDN-001 was associated with a mean 2.0mm reduction in proptosis as measured by MRI.

Viridian Therapeutics, Inc.’s anti-IGF-1R monoclonal antibody candidate, VRDN-001, has garnered attention after promising proof-of-concept data in chronic thyroid eye disease (TED) but not all of it is positive, with questions raised about a change to the design of its pivotal program.

TED, also known as Graves’ disease, is a debilitating rare disorder characterized by inflammation within the orbit of the eye,...

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