Viking Therapeutics Reports Positive 52-Week Data from Phase 2b Study of VK2809 in NASH Patients

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company, recently shared positive 52-week histologic data from its Phase 2b VOYAGE study focusing on VK2809, an innovative liver-selective thyroid hormone receptor beta agonist. The study involved patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). Previously, the primary endpoint of the study—statistically significant reductions in liver fat content from baseline to Week 12 compared to placebo—had been met successfully. The latest results emphasize the achievement of the secondary endpoints through histologic evaluation after 52 weeks of VK2809 treatment.

Histologic Efficacy at 52 Weeks

The secondary endpoint of NASH resolution without fibrosis worsening showed that VK2809-treated patients experienced notable improvements. Specifically, NASH resolution was seen in 63% to 75% of VK2809 recipients, compared to just 29% in the placebo group. On a combined analysis, 69% achieved NASH resolution (p<0.0001 vs. placebo), which was defined by a non-alcoholic fatty liver disease activity score (NAS) indicating minimal inflammation and no ballooning.

Regarding fibrosis improvement without worsening NASH, results showed that 44% to 57% of patients treated with VK2809 saw improvements compared to 34% in the placebo group. When combining all VK2809 treatment groups, 51% of patients achieved fibrosis improvement (p=0.03 vs. placebo).

For the endpoint measuring both NASH resolution and fibrosis improvement, VK2809 treatment led to responses in 40% to 50% of cases, against 20% for placebo (p<0.05 for the 5 mg and 10 mg QOD cohorts). Across all VK2809 groups, 44% met this combined endpoint (p=0.003 vs. placebo).

Durability and Sensitivity Analyses

The consistency of the study results was verified through various sensitivity analyses. A more stringent analysis, which considered missing data as non-responders, reaffirmed the robustness of VK2809's efficacy.

Reduction in Liver Fat Content

In addition to achieving histologic endpoints, VK2809 also maintained its efficacy in reducing liver fat content. At Week 12, VK2809-treated patients had shown significant liver fat reductions, which continued through Week 52. The mean change from baseline ranged from 37% to 55%. The response rate, defined by a reduction in liver fat ≥30%, ranged from 64% to 88%, with all VK2809 groups showing considerable improvements compared to placebo.

Impact on Plasma Lipids

VK2809 demonstrated a favorable impact on plasma lipids, with placebo-adjusted reductions in LDL-C by 20% to 25% (p<0.01 for each treatment group). Additionally, the treatment lowered triglycerides and atherogenic proteins like apolipoprotein B (ApoB), lipoprotein (a) [Lp(a)], and apolipoprotein C-III (ApoC-III), suggesting a potential cardio-protective benefit.

Safety and Tolerability

VK2809's safety and tolerability profile was encouraging. Adverse events were mostly mild or moderate, with a low discontinuation rate due to adverse events balanced across VK2809 and placebo groups. Only one serious adverse event (SAE) related to VK2809 was reported, involving a patient with a psychiatric disorder. Gastrointestinal (GI) tolerability was excellent, mirroring the 12-week data.

Study Design and Participants

The VOYAGE study was a randomized, double-blind, placebo-controlled trial spanning multiple centers internationally. It aimed to evaluate VK2809's efficacy, safety, and tolerability in patients with biopsy-confirmed NASH and fibrosis. The primary endpoint focused on liver fat content changes from baseline to Week 12, while secondary objectives included histologic changes after 52 weeks of treatment.

In summary, Viking Therapeutics' VK2809 has shown significant promise in treating NASH and fibrosis, with robust histologic improvements, liver fat reductions, and favorable safety and tolerability profiles. These results underscore the potential of VK2809 as a leading therapeutic agent in addressing metabolic liver diseases.

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