Conference call scheduled for 4:30 p.m. ET today
- Phase 2b VOYAGE Study Evaluating VK2809 for the Treatment of NASH Proceeding
- Phase 1b Proof-of-Concept Trial Evaluating VK0214 in X-ALD Patients Underway
- Data From New Program Evaluating Novel Dual Agonists for Metabolic Disorders Presented at ObesityWeek® 2021
- Balance Sheet Remains Strong, Supporting Advancement of Clinical Programs into Late-Stage Development
SAN DIEGO, Nov. 3, 2021 /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 third quarter and nine months ended September 30, 2021, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Quarter Ended September 30, 2021 and Other Recent Events:
"The third quarter was a busy and productive time for Viking as we continued to make progress with our lead clinical programs targeting NASH and X-ALD, and expanded our pipeline with an additional program for metabolic disorders," stated Brian Lian, Ph.D., chief executive officer of Viking. "Enrollment continues in our Phase 2b VOYAGE trial evaluating VK2809, our novel thyroid hormone beta receptor agonist, in patients with NASH and fibrosis. During the quarter, we also continued enrollment in our Phase 1b clinical trial evaluating VK0214, our second thyroid hormone beta receptor agonist, in patients with X-ALD. VK0214 has demonstrated a promising therapeutic profile in preclinical and clinical studies to date. In addition to our clinical activities, earlier this week we presented two posters at ObesityWeek®, the annual meeting of The Obesity Society, highlighting promising initial data from a series of novel, internally developed dual agonists of the GLP-1 and GIP receptors. These compounds produced significant improvements in metabolic profile in an in vivo model of NASH and obesity, and we expect to begin clinical development with this program in the coming months. Finally, supporting our development activities is a strong balance sheet that has positioned the company well to advance our clinical programs into late-stage development."
Pipeline and Corporate Highlights
- Phase 2b VOYAGE study evaluating VK2809 for the treatment of NASH ongoing. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype. The compound has demonstrated promising therapeutic potential in a range of lipid disorders, including non-alcoholic steatohepatitis (NASH). A prior 12-week Phase 2a study evaluating VK2809 in patients with non-alcoholic fatty-liver disease and hypercholesterolemia, successfully achieved both its primary and secondary endpoints, with treated patients demonstrating highly statistically significant reductions in liver fat content as well as improvements in LDL-cholesterol (LDL-C). Patients receiving VK2809 in this study also demonstrated significant reductions in other plasma lipids, such as triglycerides, apolipoprotein b, and lipoprotein (a). These data suggest important cardiometabolic benefits for patients, a distinction that may represent an advantage compared with mechanisms that have been associated with elevations in lipids known to increase cardiovascular risk. No serious adverse events were reported in this trial among patients receiving VK2809 or placebo. Findings from follow-up evaluations of the Phase 2a data, most recently in an oral presentation during the 2020 EASL conference, where the compound's durability and breadth of activity across various NASH risk factors were highlighted, continue to strengthen the promising therapeutic profile of VK2809.VK2809 is currently being evaluated in a Phase 2b trial in patients with NASH. This trial, called VOYAGE, is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. The study is targeting enrollment of patients across five treatment arms: 1.0 mg daily; 2.5 mg daily; 5.0 mg every other day; 10.0 mg every other day; and placebo. The primary endpoint of the study will evaluate the relative change in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809, as compared to placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing.During the third quarter, screening and enrollment continued at both U.S. and ex-U.S. study sites, and the company expects to report the initial data from this trial in 2022.
- Phase 1b proof-of-concept trial evaluating VK0214 in X-ALD patients underway. VK0214 is a novel, orally available thyroid hormone receptor beta agonist being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a rare neurodegenerative disease for which there are currently no pharmacologic treatment options. Earlier this year, the company completed the first clinical study of VK0214; a randomized, double-blind, placebo-controlled, single ascending dose and 14-day multiple ascending dose Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of VK0214 in healthy volunteers. This study successfully achieved its primary objective, with VK0214 shown to be safe and well-tolerated at all doses evaluated. Subjects receiving VK0214 in the 14-day multiple ascending dose study experienced reductions in LDL-C, triglycerides, and other plasma lipids, many of which reached statistical significance. No serious adverse events were reported in the Phase 1 study, and no treatment- or dose-related trends were observed for gastrointestinal side effects, vital signs, or cardiovascular measures. Treatment with VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily oral dosing.In June 2021, the company initiated a four-week Phase 1b study of VK0214. This trial is a randomized, double-blind, placebo-controlled, multi-center study in adult male patients with the adrenomyeloneuropathy (AMN) form of X-ALD. AMN is the most common form of X-ALD, affecting approximately 50% of those with the disease. The study is initially targeting enrollment across three cohorts: placebo, VK0214 dosed at 20 mg daily, and VK0214 dosed at 40 mg daily. Pending a blinded review of preliminary safety, tolerability, and pharmacokinetic data, additional dosing cohorts may be pursued.The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period, and to assess the efficacy of VK0214 at lowering plasma levels of very long chain fatty acids (VLCFAs) in patients with AMN. Secondary objectives include an evaluation of the pharmacokinetics of VK0214 in this population. The company currently expects top-line results from this study to be available in 2022.
- Data from new program focused on dual incretin receptor agonists presented at ObesityWeek® 2021. The company recently announced results from preclinical studies of a wholly-owned, internally developed series of dual-acting agonists of the glucagon-like peptide-1, or GLP-1, and the glucose-dependent insulinotropic polypeptide, or GIP, receptors. These compounds may provide therapeutic benefit in a range of metabolic disorders, such as NASH, obesity, and type 2 diabetes. Initial data from this program were presented this week in two posters at ObesityWeek 2021, the annual meeting of The Obesity Society. Highlights from the posters include:
- Treatment with Viking dual agonists for 21 days resulted in mean reductions in body weight of up to 27% relative to vehicle (p