Viking Therapeutics' VK0214 Shows Encouraging Safety, Tolerability Profile In Healthy Volunteers

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  • Viking Therapeutics Inc VKTX has announced results from its Phase 1 trial of VK0214 in healthy volunteers.
  • VK0214 demonstrated encouraging safety and tolerability at all doses, as well as a predictable pharmacokinetic (PK) profile.
  • No serious adverse events were reported, and no treatment or dose-related trends were observed for vital signs, gastrointestinal effects, cardiovascular measures, or physical examinations.
  • VK0214 demonstrated dose-dependent exposures, no evidence of accumulation following multiple doses.
  • The results also showed that subjects who received VK0214 experienced reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B following 14 days of treatment at all VK0214 doses.
  • In addition to general lipid assessments, an evaluation of very-long-chain fatty acids (VLCFAs) was also performed.
  • Despite relatively low baseline levels and the presence of a functional ABCD1 gene in healthy volunteers, VK0214 reduced VLCFA levels at all doses above 5 mg.
  • Numerical improvements above 20% from baseline were observed.
  • The company expects to initiate a Phase 1b study of VK0214 for X-linked adrenoleukodystrophy (X-ALD) in the coming weeks.
  • X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells, a process known as demyelination.
  • Price Action: VKTX shares are up 4.6% at $6.36 during the premarket trading session on the last check Thursday.
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