Alnylam' Reveals Detailed 18-Month Data From Vutrisiran Trial In Inherited Disease

Alnylam Pharmaceuticals Inc ALNY has announced detailed data from HELIOS-A Phase 3 study of vutrisiran at 18 months in patients with transthyretin-mediated (ATTR) amyloidosis.

  • Transthyretin amyloidosis is characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues. 
  • The details follow topline data announced in October 2021, showing that the Phase 3 trial met all secondary endpoints measured at 18 months. 
  • Vutrisiran treatment (N=122) resulted in a 0.46 point mean decrease (improvement) in the modified Neuropathy Impairment Score compared to a 28.09 point mean increase (worsening) in the placebo group (N=77).
  • Vutrisiran showed a 1.2 point mean decrease (improvement) in quality of life score versus a 19.8 point mean increase (worsening) in the placebo arm.
  • Vutrisiran treatment resulted in 0.024 meters/second mean decrease in 10-MWT compared to a 0.264 in the placebo group.
  • Vutrisiran exhibited a 25.0 point mean increase (improvement) in nutritional status vs. a 115.7 point mean decrease in patients on placebo.
  • The data exhibited statistically significant improvement in clinical endpoints compared to placebo and non-inferiority in serum TTR reduction compared to the within-study Onpattro (patisiran) arm.
  • Vutrisiran is under review by the FDA (action date April 14, 2022), the European Medicines Agency, Brazilian & Japanese regulatory authorities.
  • Price Action: ALNY shares are up 0.16% at $138.53 during the premarket session on the last check Friday.
Loading...
Loading...
ALNY Logo
ALNYAlnylam Pharmaceuticals Inc
$284.44-1.58%

Stock Score Locked: Want to See it?

Benzinga Rankings give you vital metrics on any stock – anytime.

Reveal Full Score
Edge Rankings
Momentum
94.88
Growth
Not Available
Quality
Not Available
Value
2.21
Price Trend
Short
Medium
Long
Market News and Data brought to you by Benzinga APIs

Posted In:
Comments
Loading...