Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The Digital International Liver Congress™ 2020

Rhea-AI Summary

Viking Therapeutics (NASDAQ: VKTX) announced promising results from its Phase 2 study of VK2809 for non-alcoholic fatty liver disease (NAFLD) presented at the Digital International Liver Congress 2020. The 12-week study showed a median reduction of 45.4% in liver fat content at Week 16 for VK2809-treated patients, compared to 18.7% for placebo. Notably, 70.4% of VK2809 patients were responders, achieving ≥30% reduction in liver fat. The findings indicate VK2809's potential as a leading treatment for NASH, providing the basis for future dosing strategies and ongoing development in the Phase 2b VOYAGE study.

Positive

• Statistically significant median reduction of 45.4% in liver fat content at Week 16 for VK2809 patients versus 18.7% for placebo.
• 70.4% of VK2809-treated patients were responders, achieving ≥30% reduction in liver fat.
• VK2809 demonstrated consistent efficacy across various patient risk factors, showing its potential as a leading treatment.

Negative

• None.

SAN DIEGO, Aug. 28, 2020 /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 presentation of new results from the company's 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C) at the Digital International Liver Congress^™ 2020. The study results were featured in an oral presentation at the annual meeting of the European Association for the Study of the Liver (EASL), being held virtually August 27-29, 2020.

Highlights from the oral presentation include newly reported data demonstrating that patients treated with VK2809 experienced durable, statistically significant reductions in liver fat content that were maintained at Week 16, four weeks after administration of the last dose in the 12-week study. Additionally, new analyses of 12 week study results demonstrated that patients receiving VK2809 experienced significant reductions in liver fat content irrespective of various baseline characteristics and common risk factors for non-alcoholic steatohepatitis (NASH).

Data presented at The Digital International Liver Congress 2020 include:

Reduction in Liver Fat Content at Week 16

At Week 16, four weeks following completion of treatment, study results demonstrated that VK2809-treated patients maintained statistically significant reductions in liver fat content, both as compared to baseline and as compared to placebo. VK2809-treated patients experienced a statistically significant median reduction in liver fat content of 45.4% at Week 16 as compared to an 18.7% reduction for placebo. Additionally, at Week 16, 70.4% of all VK2809-treated patients were still considered responders, experiencing ≥ 30% relative reduction from baseline in liver fat content, as compared to 22.2% for placebo-treated patients. Of note, 100% of patients receiving 5 mg of VK2809 dosed daily were still considered responders at Week 16. These results highlight the durability of liver fat content reduction achieved with VK2809 treatment, as patients received their final dose of VK2809 at Week 12, four weeks prior to the Week 16 assessments. The overall data from this study provide strong rationale for further development of VK2809 in the setting of NASH, and may indicate opportunities for multiple dosing strategies, including chronic, intermittent, or the potential cycling of treatment modalities.

Week 16 Results	Placebo	All VK2809-Treated
Percentage of patients experiencing ≥ 30% reduction in liver fat	22.2%	70.4% (p=0.0083 vs. placebo)
Median relative % change in liver fat by MRI-PDFF	-18.7%	-45.4% (p=0.0053 vs. placebo)
Mean absolute % change in liver fat by MRI-PDFF	-2.0%	-7.5% (p=0.0027 vs. placebo)

"We are pleased with the durability of therapeutic response achieved with VK2809 in this study. Not only did patients receiving VK2809 maintain significant liver fat reductions many weeks after their final study dose, but more than 70% of all VK2809-treated patients still qualified as responders four weeks post-treatment," said Brian Lian, Ph.D., chief executive officer of Viking. "Responders, defined as patients achieving at least a 30% decrease in liver fat content, have been shown to demonstrate a higher probability of experiencing histological improvement in NASH, making these results particularly exciting. These latest results offer further support for what we believe is a best-in-class therapeutic profile for VK2809 and we look forward to completing our ongoing Phase 2b VOYAGE study in patients with biopsy-confirmed NASH."

Consistent Reduction in Week 12 Liver Fat Content Reported Across Baseline Characteristics and Common NASH Risk Factors

Common NASH Risk Factors

New analyses of Week 12 study results demonstrated significant reductions in liver fat content among patients receiving VK2809 as compared to placebo regardless of the presence of common risk factors for NASH, including baseline levels of alanine aminotransferase (ALT) above the upper limit of normal (ALT > xULN), body mass index (BMI) ≥ 30, hypertension and Hispanic ethnicity.

Mean Relative % Change in Liver Fat in NASH Risk Factor Subsets at Week 12
NASH Risk Factor	Placebo	All VK2809-Treated
Baseline ALT > xULN	-2.1%	-57.4% (p=0.0001 vs. placebo)
BMI ≥ 30	-7.8%	-51.3% (p=0.0151 vs. placebo)
Hypertension (BP ≥ 140 mmHg)	6.2%	-54.9% (p=0.017 vs. placebo)
Hispanic Ethnicity	-7.2%	-49.0% (p=0.0054 vs. placebo)

Baseline Liver Fat Content and Baseline Glucose Levels

Newly presented data also demonstrated consistent reductions in liver fat content levels for VK2809-treated patients across the spectrum of baseline liver fat content levels. Similarly, consistent liver fat content reductions were seen for VK2809-treated patients at Week 12 regardless of baseline blood glucose levels, including among those with normal baseline blood glucose and those considered pre-diabetic.

"The consistency and durability of efficacy reported with VK2809 in this trial regardless of therapeutic dose, baseline patient characteristics or underlying NASH risk factors is encouraging. Particularly noteworthy is that VK2809-treated patients with NASH risk factors including elevated baseline ALT, obesity and hypertension experienced reductions in liver fat that were significantly greater than observed among patients receiving placebo," stated Rohit Loomba, M.D., MHSc, Director, NAFLD Research Center, and Professor of Medicine, University of California at San Diego. "These latest results build upon the impressive previously-announced findings from this clinical trial and strongly support the ongoing evaluation of VK2809 as a potential important treatment for NASH."

As previously reported, the Phase 2 study of VK2089, Viking's novel liver-selective thyroid receptor beta agonist, successfully achieved both its primary and secondary efficacy endpoints, demonstrating median relative reductions in liver fat ranging from approximately 54% to 60%, and response rates of up to 100%, both of which represent unprecedented efficacy from an oral agent. Additionally, VK2809 was shown to be safe and well tolerated at all doses evaluated in the study. No serious adverse events were reported among patients receiving either VK2809 or placebo.

Viking is currently evaluating VK2809 in the Phase 2b VOYAGE study in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.

Study Design

The Phase 2 study was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of VK2809 dosed orally in patients with elevated LDL-C and NAFLD. Patients were randomized to receive placebo, 5 mg VK2809 dosed daily, 10 mg VK2809 dosed every other day, or 10 mg VK2809 dosed daily for 12 weeks. The trial's primary endpoint assessed the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. The secondary endpoint evaluated changes in liver fat content by magnetic resonance imaging, proton density fat fraction (MRI-PDFF).

About VK2809 and the VOYAGE Trial

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, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. In 2019, the company initiated the Phase 2b VOYAGE trial. This trial 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 ranging from stages F1 to F3. The study is targeting enrollment of approximately 340 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 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. The study's independent data monitoring committee recently convened as part of its scheduled review process and recommended that VOYAGE continue as planned.

About Viking Therapeutics, Inc.

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, orally available, first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. 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 2 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 VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy (X-ALD). The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, 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 development activities and plans regarding VK2809 and its prospects. 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 VK2809 and VK0214; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; risks related to the COVID-19 pandemic; 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, 2019, 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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SOURCE Viking Therapeutics, Inc.

FAQ

What were the results of the VK2809 Phase 2 study presented by Viking Therapeutics?

The Phase 2 study showed a median reduction of 45.4% in liver fat content at Week 16 for VK2809-treated patients, significantly outperforming the 18.7% reduction in the placebo group.

What does the term 'responders' refer to in the VK2809 study?

Responders are defined as patients achieving at least a 30% decrease in liver fat content; in the study, 70.4% of VK2809 patients were classified as responders.

What is the significance of VK2809’s results for patients with NASH?

The study results suggest that VK2809 may lead to higher probabilities of histological improvement in patients with NASH, indicating its potential as an effective treatment.

What are the next steps for Viking Therapeutics after the VK2809 study?

Viking Therapeutics plans to continue developing VK2809, with ongoing evaluation in the Phase 2b VOYAGE study targeting biopsy-confirmed NASH.

How does VK2809 compare in efficacy against placebo?

VK2809 showed statistically significant improvements over placebo, with a higher percentage of patients achieving significant liver fat reductions.