Conference call scheduled for 4:30 p.m. ET today Results From Phase 2 VENTURE Trial of GLP-1/GIP Agonist VK2735 in Obesity Demonstrated Up to 13.1% Placebo-Adjusted Weight Loss (14.7% From Baseline) at 13 Weeks; Shown to be Safe and Well-Tolerated Results From Phase 1 Trial of Oral VK2735 Demonstrated Promising Safety and Tolerability With Up to 3.3% Placebo-Adjusted Weight Loss (5.3% From Baseline) at 28 Days 52-Week Histology Results From Phase 2b VOYAGE Study Evaluating VK2809 for the Treatment of NASH and Fibrosis Expected in 2Q24 Completed Public Offering of Common Stock Raising Gross Proceeds of Approximately $630 Million; Quarter-End Cash Position of $963 Million SAN DIEGO, April 24, 2024 /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 its financial results for the first quarter ended March 31, 2024, and provided an update on its clinical pipeline and other corporate developments. Highlights from the Quarter Ended March 31, 2024, and Other Recent Events: "The first quarter of 2024 was an exceptional period for Viking," stated Brian Lian, Ph.D., chief executive officer of Viking.  "During the quarter, the company reported positive top-line results from the Phase 2 VENTURE study of subcutaneous VK2735 in obesity and encouraging initial data from a Phase 1 study of our novel tablet formulation of this compound.  We plan to meet with regulators to discuss the path forward for both programs and expect to advance each into further development later this year.  In addition, in the first quarter we completed the 52-week biopsies for the Phase 2b VOYAGE study of our thyroid hormone beta receptor agonist VK2809 in biopsy-confirmed NASH and fibrosis.  As we've previously reported, this study successfully achieved its primary endpoint after 12 weeks of treatment and affirmed VK2809's potent effect on liver fat, along with its favorable tolerability and safety profile.  We plan to report data on histologic changes assessed after 52 weeks of treatment later this quarter.  Finally, during the first quarter, the company completed a public offering of common stock, raising approximately $630 million of gross proceeds to aggressively develop our pipeline programs through important clinical milestones." Pipeline and Recent Corporate Highlights Phase 2 VENTURE Trial of VK2735 in Obesity Achieves Primary and Secondary Endpoints Demonstrating Up to 13.1% Placebo-Adjusted Weight Loss (14.7% From Baseline) at 13 Weeks; Shown to be Safe and Well-Tolerated. VK2735 is a wholly owned dual agonist of the glucagon like peptide-1, or GLP-1 receptor, and the glucose dependent insulinotropic polypeptide, or GIP receptor, for the potential treatment of obesity and other metabolic disorders.  During the third quarter of 2023, Viking initiated the Phase 2 VENTURE trial, evaluating VK2735 in patients with obesity. The VENTURE trial was a randomized, double-blind, placebo-controlled multicenter study to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously, once weekly for 13 weeks. The trial was designed to enroll adults who are obese [Body Mass Index (BM)I ≥30 kg/m2] or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbid condition. Due to heightened clinician and patient interest, the trial size was increased to 176 patients, compared with the original target of 125 patients.  The primary endpoint of the study assessed the percent change in body weight from baseline to Week 13 among patients treated with VK2735 as compared with placebo. Secondary and exploratory endpoints evaluated a range of additional safety and efficacy measures. The doses evaluated ranged from 2.5 mg to 15 mg, with titration utilized for final doses ≥5 mg. During the first quarter of 2024, Viking announced positive top-line results from the VENTURE study. The trial successfully achieved its primary endpoint and all secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. Additionally, the study showed VK2735 treatment to be safe and well tolerated, with the majority of treatment emergent adverse events (TEAEs) being categorized as mild or moderate. With respect to the primary endpoint, patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7%, as well as statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%. Statistically significant differences compared to placebo were observed for all doses starting at Week 1 and were maintained throughout the course of the study. Weight loss in all treated cohorts appeared to be progressive through 13 weeks and did not show evidence of plateauing. The company believes this suggests that further weight loss could be achieved through extended dosing beyond the 13-week treatment period of this study. VK2735 also demonstrated encouraging safety and tolerability in the VENTURE study, with the majority of observed adverse events (AEs) being reported as mild or moderate. Treatment and study discontinuation rates among VK2735 cohorts were well-balanced compared with placebo. TEAE rates in the study were slightly higher in VK2735-treated patients relative to placebo treated patients, driven primarily by expected differences in gastrointestinal (GI)-related events. Of the GI-related AEs, 95% were reported as mild or moderate. Across all cohorts in the VENTURE study, GI-related AEs were most prevalent during the first week of the study, with observed rates generally declining through the remainder of the study. Based on these results, Viking intends to meet with the U.S. Food and Drug Administration (FDA) to discuss next steps in the development of VK2735. Phase 1 Trial of Oral VK2735 Demonstrates Encouraging Safety and Tolerability; Positive Signs of Clinical Activity With Up to 3.3% Placebo-Adjusted Weight Loss (5.3% From Baseline) After 28 Days; Shown to be Safe and Well-Tolerated. Viking believes the potential to provide both subcutaneous and oral dosage forms may represent an important option for patients and may significantly expand the market opportunity for VK2735. To this end, in 2023 Viking initiated a Phase 1 clinical study to evaluate a novel oral tablet formulation of VK2735. The tablet formulation study is an extension of the prior single ascending and multiple ascending dose Phase 1 trial of the subcutaneous formulation, and is a randomized, double-blind, placebo-controlled trial in healthy adults with a minimum BMI of 30 kg/m2. The dose levels evaluated to date have ranged from 2.5 mg daily to 40 mg daily. The primary objective of the study is to evaluate the safety and tolerability of VK2735 administered as an oral tablet once daily for 28 days. The secondary objective is to evaluate the pharmacokinetics of orally administered VK2735 in healthy subjects. Exploratory pharmacodynamic measures include assessments of changes in body weight and other metrics. During the first quarter, Viking reported the initial data from this study.  With respect to safety and tolerability, oral VK2735 was shown to be safe and well tolerated following once daily dosing for up to 28 days, at doses that were titrated up to 40 mg. Among subjects receiving oral VK2735, all TEAEs were reported as mild or moderate in severity, with the majority, 76%, reported as mild. Similarly, all GI-related AEs in this study were reported as mild or moderate, with the majority, 79%, reported as mild. Mild nausea was reported in 14% of subjects receiving VK2735. No vomiting was reported among subjects receiving VK2735. Diarrhea was reported in 3% of VK2735 treated subjects, compared with 20% of subjects receiving placebo. Overall, no clinically meaningful differences were reported for GI AEs among subjects treated with VK2735 compared with placebo. Importantly, to date no serious adverse events (SAEs) have been reported in this study. An exploratory assessment of change in body weight showed that subjects receiving oral VK2735 demonstrated dose dependent reductions in body weight, ranging up to 5.3% from baseline. Placebo-adjusted reductions in body weight reached up to 3.3% from baseline. Body weight reductions compared with baseline and placebo were statistically significant at the highest dose evaluated. Weight loss in the 28-day window of this study was progressive at the 20 mg and 40 mg dose levels, with no plateau observed. Given the promising weight loss signal demonstrated, along with the excellent tolerability profile observed thus far, Viking is pursuing further dose escalation in this study. In addition, based on the encouraging trajectory of weight loss observed in this study, and the lack of a plateau at 28 days for higher dose cohorts, the company believes that further benefits might be anticipated from longer dosing periods. To this end, Viking plans to initiate a Phase 2 trial in patients with obesity later this year. Histology Results for Phase 2b VOYAGE Study Evaluating VK2809 for the Treatment of NASH and Fibrosis Expected in 2Q24. VK2809 is an orally available, small molecule agonist of the thyroid hormone receptor that is selective for liver tissue, as well as the beta isoform of the receptor. Viking is currently evaluating VK2809 in the Phase 2b VOYAGE study, in patients with biopsy-confirmed NASH and fibrosis. 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 (MRI-PDFF), as well as F2 and F3 fibrosis. The primary endpoint of the study evaluated 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. During the second quarter of 2023, Viking announced positive top-line results from the VOYAGE study. The trial successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo. The median relative change from baseline in liver fat as assessed by MRI-PDFF ranged from 38% to 55% for patients receiving VK2809. In addition, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content (p<0.0001), a level of reduction that is associated with a greater likelihood of histologic improvement in NASH. Additionally, VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and atherogenic lipoproteins, all of which have been correlated with cardiovascular risk. These results support prior data demonstrating that VK2809 may offer a cardio-protective benefit through its robust reduction in plasma lipids. The results for the primary endpoint of the VOYAGE Phase 2b study were highlighted in a November 2023 presentation at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). A key takeaway from the presentation was the finding that treatment with VK2809 produced comparable liver fat reductions among patients with or without type 2 diabetes, as well as in patients with either F2 or F3 fibrosis. Specifically, among patients with type 2 diabetes, reductions from baseline in liver fat were reported for all VK2809 cohorts, ranging from 36% to 54% at Week 12. This effect size was comparable to that reported for patients without type 2 diabetes. Treatment with VK2809 also demonstrated potent reductions in liver fat among patients with either F2 or F3 fibrosis, with liver fat reductions ranging up to approximately 58% from baseline. These data suggest that activation of the thyroid hormone beta receptor ...