Viking therapeutics had been carrying out Phase Ib of its trial for adrenoleukodystrophy (X-ALD) patients until the FDA placed a hold on their research in order to seek additional preclinical data.
X-ALD, in addition to being a mouthful, is a rare genetic disorder that impacts the white matter of the brain. White matter contains the axons that relay nerve impulses between cells, and damage to this material in the adrenal cortex causes serious neurological problems. The X comes from ALD being X-linked to recessive genes.
The Viking treatment, called VK0214, is an oral medication that showed encouraging safety and tolerability when given as an ascending dose in Phase I trials.
The FDA has placed a hold on the Viking treatment because it is seen by the agency as a Phase II rather than Phase Ib clinical trial. Before one can conduct a Phase II trial, rodent genotoxicity research is required by the FDA.
The company expects a short-term delay but does not anticipate a longer disruption to the study timeline.
When speaking with Clinical Trials Arena, the Viking CEO, Brian Lian said: “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.”
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