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Viridian Therapeutics Announces Positive VRDN-008 Phase 1 Results Supporting Potential Best-in-Class Profile with Every-8-Week Subcutaneous Dosing

  • VRDN-008 demonstrated a 74% peak reduction in IgG levels with sustained effects lasting through 8 weeks in healthy volunteers following subcutaneous dosing
  • The drug features an extended half-life of 15–18 days, which is up to 6 times longer than first-generation Fc fragments
  • VRDN-008 exhibited a favorable safety profile by sparing albumin & LDL levels, with no serious adverse events or dose-limiting toxicities observed
  • Viridian plans to initiate at least one pivotal clinical trial in 2027, starting with a myasthenia gravis (MG) study in mid-2027 pending regulatory feedback
  • The planned MG trial will utilize a placebo-controlled, multi-arm design testing Q4W & Q8W dosing to support a direct path to registration
  • Administration of VRDN-008 is planned via the Enable enFuse® on-body injector to facilitate simple at-home self-injection
  • Viridian intends to develop VRDN-008 across multiple autoantibody-mediated autoimmune diseases beyond its initial MG focus
  • An investor conference call & webcast regarding these results was scheduled for 8:00 am ET on the announcement date