Viking Therapeutics, Inc. (VKTX) stock prices were up by a marginal 0.83% as of the market closing on June 16th, 2021, bringing the price per share up to USD$6.08 at the end of the trading day. Subsequent premarket fluctuations saw the stock rise by a more significant 5.10%, bringing it up to USD$6.39.
VK0214 Clinical Trial
The company announced on June 17th, 2021 the results from its Phase 1 clinical trial of VK0214, the unique, orally available small molecule thyroid receptor beta agonist. Having been both single ascending dose and multiple ascending doses, the trial was designed for the development of the treatment for X-linked adrenoleukodystrophy (X-ALD). As per the results of the study, VK0214 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic (PK) profile. The initiation of Phase 1b of the study of VK0214 in X-ALD patients is set to commence in the upcoming weeks.
Details of the Study
The Phase 1 trial was a double-blind, placebo-controlled study of randomized healthy volunteers, with a primary objective of evaluating the safety and tolerability of VK0214 administered orally over the course of 14 days. The evaluation of the pharmacokinetics of the treatment following single and multiple doses was the secondary objective of the study.
Layout of the Study
The first portion of the study was designed to evaluate single doses of the treatment, with the second portion seeing the administering of VK0214 once daily to the study subjects for a period of 14 days. Both parts of the study reported subsequent cohorts having received higher doses of the treatment successfully.
Results of the Trial
The safety profile of VK0214 was consolidated, with a demonstrated tolerability at all the doses that were evaluated in the study. There were no serious adverse events reported; and no study-related trends were observed for changes in vital signs, gastrointestinal effects, cardiovascular measures, or physical examinations. The treatment demonstrated exposures that were dose-dependent, with no evidence of accumulation subsequent to multiple doses. The half-life of the treatment was also found to be consistent with expected dosing regimens of once a day.
Peripheral Findings
Potential pharmacodynamic effects following exposure to the treatment were determined by laboratory assessments that included a lipid panel. The findings indicated exposure to VK0214 resulted in a reduction in LDL-C triglycerides and apolipoprotein B after 14 days of treatment at all dosage levels. While the study wasn’t powered for it, it did achieve statistical significant in many of the observed lipid reductions.
Future Outlook for VKTX
Armed with the promising development of its flagship treatment, VKTX is poised to continue its trajectory of success. The company is keen to push for the commercialization and proliferation of VK0214. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.
