Benzinga | Jan 24, 2022 07:08AM EST

Viking Therapeutics Announces Clinical Hold On Phase 1b Trial Of VK0214 In Patients With X-ALD

Viking Therapeutics, Inc. (Viking) (NASDAQ:VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that its Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD) has been placed on clinical hold by the United States Food and Drug Administration (FDA). The FDA has requested an additional preclinical study prior to continuing the Phase 1b study of VK0214 in X-ALD. The request is not due to any findings from ongoing or previously completed studies. The company expects to provide the information to the FDA in the second quarter.

The company was recently informed that the FDA considers the ongoing trial to be a Phase 2 trial rather than a Phase 1b. As a Phase 2 trial a rodent genotoxicity study is required prior to continuation. The company had planned to conduct this study prior to 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.

"We look forward to providing the FDA with the requested information in a timely fashion. The current request is in keeping with industry guidance for Phase 2 studies and is not based on data from previously submitted or ongoing studies. We are confident in the overall safety and potential efficacy profile of VK0214 and expect to submit a response with a goal to resume dosing in the study later this year," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics.

VK0214 is a novel, orally available small molecule TR? agonist that has been granted orphan drug designation by the FDA for the treatment of X-ALD. Results from a successful Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy subjects showed that VK0214 demonstrated encouraging safety and tolerability, as well as predictable pharmacokinetics. In addition, subjects who received VK0214 experienced reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B following 14 days of treatment.