U.S. FDA Lifts Clinical Hold On Viking Therapeutics' Initial-Stage Genetic Disorder Study

Viking Therapeutics VKTX announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD).

The agency lifted the clinical hold following its review of results from an in vivo genotoxicity study that it had requested due to the study being conducted with multiple doses in patients.

The company expects to resume study enrollment in the coming weeks.

The Phase 1b study of VK0214 is designed to enroll patients with the adrenomyeloneuropathy (AMN) form of X-ALD. AMN is the most common form of X-ALD.

Brian Lian, Chief executive officer, commented : ”We look forward to resuming study activities and working to complete patient enrollment as quickly as possible. We are confident in the overall safety and potential efficacy profile of VK0214 to date, and are eager to continue its advancement as a potential disease modifying treatment for patients with X-ALD."

Price Action : Viking Therapeutics shares are trading around 2 percent higher at $3.54 on Tuesday during pre-market session.