Drugs

Clinical Hold Lifted on Viking X-ALD Trial

FDA has lifted a clinical hold against Viking Therapeutics’ VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD), and the company says it will resume study enrollment in the coming weeks.

The agency action followed its review of results from an in vivo genotoxicity study that it had requested due to the study being conducted using multiple doses, the company says. “Viking had planned to conduct this study prior to Phase 2 but accelerated its execution based on FDA’s request,” it says. “The results showed no evidence of genotoxicity following exposure to VK0214. The company does not believe that the long-term development timeline for VK0214 has been significantly impacted by the temporary clinical hold.”

The Phase 1b study of VK0214, according to Viking, is designed to enroll patients with the adrenomyeloneuropathy, which is the most common form of X-ALD that affects about half of patients. The study also includes an exploratory assessment of the impact of VK0214 on plasma levels of very long chain fatty acids, and a pharmacokinetics evaluation in these patients.

X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown (demyelination) in the protective barriers surrounding brain and nerve cells. Viking describes VK0214 as a novel, orally available small molecule thyroid hormone beta receptor agonist that has been granted orphan drug designation by FDA for treating X-ALD. It says subjects who received VK0214 “experienced reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B following 14 days of treatment.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome