The US Food and Drug Administration (FDA) has lifted the hold placed on Viking Therapeutics’ Phase Ib clinical trial of VK0214 in X-linked adrenoleukodystrophy (X-ALD) patients.
VK0214 is a new, orally available small molecule thyroid hormone beta receptor (TRβ) agonist.
With the latest development, the company will commence subject enrolment and dosing in the trial soon.
The decision comes after the FDA carried out a review of findings from an in vivo genotoxicity study sought by the regulatory agency as the trial analysed multiple doses in patients.
Viking intended to carry out this study before commencing Phase II but expedited its execution following a request from the FDA.
The company concluded the study and submitted the data to the agency in the second quarter.
According to the findings, no indication of genotoxicity following exposure to VK0214 was observed.
The long-term VK0214 development timeline may not be affected substantially by the temporary clinical hold, Vikings noted.
The randomised, double-blind, multicentre, placebo-controlled Phase Ib trial of VK0214 will enrol adult male subjects with the adrenomyeloneuropathy (AMN) form of X-ALD.
Assessing the safety and tolerability of once a day dose of VK0214 for 28 days are the trial’s primary objectives.
An exploratory analysis of VK0214’s effect on plasma levels of very long chain fatty acids (VLCFAs) and its pharmacokinetics in these subjects will also be carried out.
Viking Therapeutics CEO Brian Lian said: “We look forward to resuming study activities and working to complete patient enrolment as quickly as possible.
“We are confident in the overall safety and potential efficacy profile of VK0214 to date, and are eager to continue its advancement as a potential disease-modifying treatment for patients with X-ALD.”
A rare metabolic disorder, X-ALD is characterised by demyelination. AMN is a most common kind of X-ALD impacting nearly 50% of such patients.