FDA Pauses PTC Therapeutics’ Trial for Huntington’s
The FDA has paused PTC Therapeutics’ U.S. enrollment for a phase 2 clinical trial of PTC518 in the treatment of patients with Huntington’s disease, a disorder in which nerve cells in the brain progressively break down.
The company said the FDA has requested additional data before it will allow the study to proceed in the U.S. but trial enrollment is ongoing in several European countries and in Australia.
The company plans on sharing data from the 12-week portion of the study in the first half of 2023. No treatment-related adverse events have been reported, the company said.