RTTNews | Jan 24, 2022 07:16AM EST

07:15 Monday, January 24, 2022 (RTTNews.com) - Biopharmaceutical company Viking Therapeutics, Inc. (VKTX) announced Monday that its Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD) has been placed on clinical hold by the U.S. 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.

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.

Read the original article on RTTNews ( https://www.rttnews.com/3256708/viking-therapeutics-says-fda-places-clinical-hold-on-phase-1b-trial-of-vk0214-quick-facts.aspx)

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