Conference call scheduled for 4:30 p.m. ET today
- Results for Phase 2 VENTURE Trial of GLP-1/GIP Agonist VK2735 in Obesity Expected in 1Q24
- Histology Results for Phase 2b VOYAGE Study Evaluating VK2809 for the Treatment of NASH and Fibrosis Expected in 1H24
- Results for Phase 1 Trial of Oral VK2735 Expected in 1Q24
- Strong Year-End Cash Position of $362 Million
SAN DIEGO, Feb. 7, 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 fourth quarter and year ended December 31, 2023, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended December 31, 2023, and Other Recent Events:
"2023 was an event-filled year for Viking, with the company achieving significant progress with each of our four clinical programs," stated Brian Lian, Ph.D., chief executive officer of Viking. "In the first quarter, we reported results from the first Phase 1 trial of VK2735, our newest clinical program, for the treatment of obesity. This study demonstrated early signals of efficacy, as well as promising safety and tolerability. Last fall, we initiated the VENTURE Phase 2 trial to evaluate VK2735's longer term clinical benefits and completed enrollment in an upsized trial more rapidly than expected. In 2023 we also initiated a complementary Phase 1 clinical trial evaluating a novel oral formulation of VK2735, which we believe may expand the market opportunity for this therapeutic. We expect to report topline results from both the VENTURE Phase 2 study and the Phase 1 trial of oral VK2735 in the first quarter of 2024. An additional highlight for 2023 was the announcement of positive topline results from our Phase 2b VOYAGE study of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis with fibrosis. This study affirmed VK2809's best-in-class profile, demonstrating statistically significant liver-fat reduction, unique lipid-lowering properties, and favorable safety and tolerability profile. We look forward to reporting the 52-week biopsy data from this study in the first half of 2024. Importantly, we completed 2023 with a strong cash position that will support our objectives for 2024 and beyond. We look forward to an exciting year ahead and thank our shareholders and partners, as well as the investigators and patients participating in our clinical programs, for their continued support."
Pipeline and Recent Corporate Highlights
- Results for Phase 2 VENTURE Trial of GLP-1/GIP Agonist VK2735 in Obesity Expected in 1Q24. 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 various metabolic disorders such as obesity, non-alcoholic steatohepatitis (NASH), and certain rare disorders. During the first quarter of 2023, Viking announced positive results from a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735 following 28 days of weekly dosing in healthy volunteers. In the MAD portion of the study, VK2735 demonstrated encouraging safety and tolerability, and positive signs of clinical activity. All cohorts receiving VK2735 experienced reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.0%. Statistically significant differences compared to placebo were maintained or improved at the Day 43 follow-up time point, 21 days after the last dose of VK2735 was administered. VK2735 also demonstrated encouraging safety and tolerability following repeated dosing. The majority of observed adverse events (98%) were reported as mild or moderate, and the majority of gastrointestinal-related adverse events (99%) were also reported as mild or moderate. This study also demonstrated VK2735's encouraging impact on liver fat and plasma lipids. Specifically, after four weekly subcutaneous doses of VK2735, subjects in the Phase 1 trial reported liver fat reductions of up to 47% from baseline. Among subjects with non-alcoholic fatty liver disease, placebo-adjusted reductions in liver fat reached approximately 59%. Though the sample size was limited, these results indicate VK2735's potential benefit in patients with various forms of fatty liver disease. With respect to plasma lipids, treatment with VK2735 produced encouraging reductions from baseline in total cholesterol of up to 21%, and reductions in LDL-cholesterol of up to 23%. In addition, plasma levels of apolipoprotein B were reduced by up to 21%. These findings are particularly interesting in light of the fact that these healthy volunteers began the study with normal baseline lipid levels. The results from this trial were featured in an oral presentation at ObesityWeek® in October 2023.During the third quarter of 2023, Viking initiated the Phase 2 VENTURE trial, evaluating VK2735 in patients with obesity. The VENTURE trial is 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 (BMI ≥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 will assess the percent change in body weight from baseline to Week 13 among patients treated with VK2735 as compared with placebo, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures. The doses being evaluated range from 2.5 mg to 15 mg, compared to the 10 mg top dose evaluated in the prior Phase 1 MAD study.The company completed enrollment in VENTURE in 4Q23 and expects to report topline results from this study in 1Q24.
- Results for Phase 1 Trial of Oral VK2735 Expected in 1Q24. Concurrent with the 1Q23 announcement of results from the Phase 1 trial of the injectable formulation of VK2735, Viking announced the initiation of a Phase 1 clinical study to evaluate a novel oral formulation of VK2735. 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.This study is an extension of the SAD/MAD Phase 1 trial described above, and is a randomized, double-blind, placebo-controlled trial in healthy adults with a minimum BMI of 30 kg/m2. 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.The company expects to report the initial data from the oral formulation Phase 1 study in 1Q24.
- Histology Results for Phase 2b VOYAGE Study Evaluating VK2809 for the Treatment of NASH and Fibrosis Expected in 1H24. 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 study also allowed for up to 25% of enrolled patients to have F1 fibrosis, provided that they possess at least one additional risk factor, such as diabetes, obesity or hypertension. 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 topline 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. Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content (p