Viking Therapeutics (VKTX) Announces New, Statistically Significant Data from VK2809 Phasae 1b in Hypercholesterolemia

November 15, 2016 7:03 AM EST
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Viking Therapeutics, Inc. (Nasdaq: VKTX) announced additional data from its previously completed Phase 1b clinical trial of VK2809 in subjects with mild hypercholesterolemia. Data from an analysis of the study participants' atherogenic protein levels demonstrated that subjects experienced statistically significant reductions in lipoprotein(a) [Lp(a)] and apolipoprotein B-100 (apo B). These results were highlighted in a poster presentation on November 14 at the American Heart Association (AHA) Scientific Sessions 2016, in New Orleans, LA.

VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in this patient population. Previously reported data have demonstrated that treatment with VK2809 leads to rapid reductions in plasma LDL cholesterol (LDL-C) and triglycerides in subjects with mild hypercholesterolemia. The new results presented at AHA outline VK2809's effect on additional proteins associated with cardiovascular disease (CVD).

The study was a randomized, double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety, tolerability and pharmacokinetics of a range of VK2809 doses in 56 subjects with elevated serum cholesterol (n = 6 per drug-treated cohort). Following 14 days of VK2809 treatment, subjects experienced statistically significant placebo-adjusted, least square mean reductions in both Lp(a) and apo B across a range of doses. Reductions in apo B ranged from 20.2% at 5 mg (p = 0.0008) to 39.6% at 40 mg (p < 0.0001); reductions in Lp(a) ranged from 31.6% at 5 mg (p = 0.12) to 54.9% at 20 mg (p = 0.002). Comparable results were obtained with or without least square mean adjustments, which account for covariates in patient characteristics.

The therapeutic importance of reducing atherogenic proteins has been highlighted in scientific literature. A report published in the Mayo Clinic Proceedings stated that Lp(a) was an independent, causal, risk factor for atherosclerosis, and that epidemiologic data show a continuous association between Lp(a) and CVD that is multiplied when both LDL-C and Lp(a) are elevated.1 Similarly, determination of apo B levels has been characterized as superior to any other cholesterol index to identify increased risk of CVD and assess the efficacy of lipid-lowering treatment.2 Thus, robust reductions of both Lp(a) and apo B, as demonstrated by VK2809 in this study, may add to the benefits of LDL-lowering therapy by further improving a patient's cardiovascular risk profile.

"These data support the promise of thyroid beta-targeted approaches for the treatment of cardiovascular and other metabolic diseases. We previously reported results showing VK2809's ability to rapidly reduce plasma LDL-C and triglycerides by up to 41% and 79%, respectively, following just 14 days of treatment," said Brian Lian, Ph.D., chief executive officer of Viking. "Today's announcement highlights the added benefit of VK2809 on reducing key proteins associated with elevated cardiovascular risks. The combined benefits from reducing both LDL-C and atherogenic proteins suggest a differentiated therapeutic profile, which may result in improved long-term benefits for patients with lipid or other metabolic abnormalities, including fatty liver disease. We look forward to the results of our ongoing Phase 2 trial of VK2809 in patients with hypercholesterolemia and fatty liver disease, which we expect to complete in 1H17."

Treatment with VK2809 was shown to be safe and well-tolerated at all doses studied in this trial. No serious adverse events were reported and no treatment- or dose-related trends were observed for abnormal vital signs, electrocardiograms, cardiac rhythm or physical examination assessments. Consistent with liver-targeted thyroid receptor activation, mild, asymptomatic elevations in liver enzymes and decreased thyroid hormone levels were observed at higher doses. Metabolically, VK2809 was not eliminated intact through the kidneys, and less than 3% of the administered dose was eliminated through the kidneys as the drug's active metabolite, VK2809A.

Viking previously announced top-line data from the Phase 1b trial which demonstrated clinically and statistically significant placebo-adjusted reductions in LDL-C ranging from 15.2% at the 5.0 mg dose (p=0.026) to 41.2% at the 20 mg dose (p<0.0001). In addition, subjects experienced placebo-adjusted reductions in triglycerides ranging from 34.8% at 5.0 mg dose (p=0.052) to 78.6% at the 40 mg dose (p=0.0001).

The company recently initiated a Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease. The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK2809 in approximately 80 patients with elevated LDL-C and non-alcoholic fatty liver disease.

References:

1Mayo Clinic Proceedings, November 2013; 88(11): 1294-1311. 2J. Intern. Med., March 2006; 259(3): 247-258.



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