Alnylam Pharmaceuticals announced Wednesday night it would end its development program for revusiran over startling data that indicated patients taking this drug had a higher chance of dying versus those being treated with a placebo.
Study safety monitors recommended the company suspend its Phase 3 trial when patients from a previous study developed nerve pain, reported Reuters.
An additional set of unblended data later demonstrated there was an imbalance of mortality in the revusiran arm of the study compared with the placebo group.
Alnylam, located in Cambridge, Massachusetts, specializes in RNA interference technology, which focuses on designing therapies that block genes from developing their designated proteins.
Revusiran’s purpose is to target a gene that produces an abnormal protein that induces amyloidosis. It’s a condition where amyloid plaques build up in organs like the heart leading to heart failure.
“Patient safety comes first. We have stopped all dosing and are actively monitoring patients across revusiran studies to ensure their safety. We will also continue to evaluate ENDEAVOUR data to understand the potential cause of these findings,” said John Maraganore, Ph.D., and Alnylam CEO in a statement.
About 206 people were enrolled in this study in which 18 died due to heart-related issues. Analysts believed the drug was slated to be a blockbuster within the next decade, explained FierceBiotech.
Other development programs under Alnylam’s umbrella are continuing without issue, but the company’s stock still plummeted more than 40 percent in after-hours trading.
Filed Under: Drug Discovery