Viking Therapeutics Announces Completion of Enrollment in Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH)

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PR Newswire

SAN DIEGO, Jan. 9, 2023

Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Range of VK2809 Doses for up to 52 Weeks; Data for Primary Endpoint Expected in First Half of 2023

SAN DIEGO, Jan. 9, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today 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.

"Thyroid receptor beta agonists are one of the most promising classes of compounds for addressing the therapeutic needs of patients with NASH and the data to date for Viking's VK2809 demonstrate best-in-class efficacy and tolerability," said Brian Lian, Ph.D., chief executive officer of Viking. "With enrollment in the VOYAGE trial now complete, we are an important step closer to generating additional data supporting the compound's anticipated therapeutic benefit for patients with NASH. We look forward to sharing topline results, including the trial's primary endpoint, during the first half of 2023."

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

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Viking Therapeutics Inc

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VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor (TRβ) 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.

About Viking Therapeutics, Inc.

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The company's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company is also developing VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. VK2735 is currently being evaluated in a Phase 1 clinical trial. In the rare disease space, the company is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). VK0214 is currently being evaluated in a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD. The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including VK2809 and VK0214, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.

For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com. Follow Viking on Twitter @Viking_VKTX.

Forward-Looking Statements

This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, and the company's other incretin receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2021, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.

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