Viking Therapeutics, Inc. announced the completion of patient enrollment in its Phase 2b clinical trial of VK2809, the company's novel liver- selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The company expects to report data for the study's primary endpoint in the first half of 2023. The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter, international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis.

Enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction, as well as F2 and F3 fibrosis. The study allowed for up to 25% of enrolled patients to have F1 fibrosis provided that they also possess at least one additional risk factor, such as diabetes, obesity or hypertension, among others. The primary endpoint of the study will evaluate the change in liver fat content from baseline to Week 12 in patients treated with VK2809 as compared to patients receiving placebo.

Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment. As previously reported, the company's 12-week Phase 2a trial of VK2809 in patients with hypercholesterolemia and non- alcoholic fatty liver disease (NAFLD) successfully achieved both its primary and secondary endpoints, demonstrating significant reductions in liver fat and plasma lipids. Patients treated with VK2809 experienced up to 60% mean relative reductions in liver fat content, and 88% of patients receiving VK2809 experienced at least a 30% reduction in liver fat content.

The observed reductions in liver fat were durable, with the majority of patients remaining responders four weeks after completion of dosing. The study also demonstrated a promising safety and tolerability profile for VK2809. No serious adverse events were reported, and the rate of gastrointestinal disturbances such as nausea and diarrhea was lower among VK2809 treated vs.

placebo patients. Further, patients treated with VK2809 experienced a reduction in plasma lipids. The elevation of such lipids, including LDL-cholesterol, triglycerides and atherogenic proteins, has been correlated with increased cardiovascular risk.

The company believes that the lipid lowering characteristics of VK2809, combined with its significant impact on liver-fat, encouraging safety and tolerability profile, and oral dosing, distinguish it from other drugs in development for this indication and strengthen its position as a best-in-class therapeutic. About VK2809 VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor (TR) that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders. The compound is currently being evaluated in a Phase 2b clinical trial in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH).

VK2809 successfully achieved primary and secondary endpoints in a Phase 2a study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD). Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression of genes associated with lipid metabolism and clearance.