Viking Therapeutics' Early Stage Trial On FDA Hold In Rare Metabolic Disorder

The FDA has placed a clinical hold on Viking Therapeutics Inc's VKTX Phase 1b trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). 

• The FDA has requested an additional preclinical study before continuing the Phase 1b study of VK0214 in X-ALD, not due to any findings from ongoing or previously completed studies. 
• The Company expects to provide the information to the FDA in Q2 of FY22.
• Related: Viking Therapeutics' VK0214 Shows Encouraging Safety, Tolerability Profile In Healthy Volunteers.
• The Company was recently informed that the FDA considers the ongoing trial a Phase 2 trial rather than a Phase 1b. 
• As a Phase 2 trial, a rodent genotoxicity study is required before continuation. 
• The Company had planned to conduct this study before Phase 2 and will now accelerate its execution. While a short-term delay is anticipated, the Company does not expect the long-term development timeline for VK0214 to be significantly impacted.
• Related content: Benzinga's Full FDA Calendar.
• X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells, a process known as demyelination. 
• Price Action: VKTX shares are down 6.82% at $3.55 during the premarket session on the last check Monday.