SAN DIEGO - 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, 2020, and provided an update on its clinical pipeline and other corporate developments.

Highlights from the Quarter Ended September 30, 2020: 'The third quarter at Viking was highlighted by continued pipeline progress, with enrollment now ongoing in two important clinical programs,' stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. 'The Phase 2b VOYAGE study of our lead NASH program, VK2809, continues and we anticipate completion of enrollment in the first half of 2021. In addition, at the EASL conference in August, we presented new data from the prior 12-week study of VK2809, demonstrating consistent liver fat reductions across high risk subgroups, as well as durable efficacy maintained four weeks after completion of dosing. With respect to our VK0214 program for X-linked adrenoleukodystrophy, we are excited to have moved this important program into the clinic, with the announcement of a Phase 1 SAD/MAD study in healthy subjects. Pending successful completion, in 2021 we plan to initiate a Phase 1b study in patients with X-ALD. Both of these clinical trials continue to advance despite disruptions resulting from the COVID-19 pandemic. Finally, to support both of these programs, we continue to judiciously manage our balance sheet and ended the quarter with $255 million in cash.'

Pipeline and Corporate Highlights

Phase 2b VOYAGE study of VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis continues. 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. The company's ongoing Phase 2b VOYAGE 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 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.

Despite disruption from the coronavirus pandemic, the majority of our U.S. clinical sites are open for enrollment. The company plans to expand the number of clinical sites over the next few months to include over 80 U.S. clinical sites and more than 90 sites globally. The company anticipates completion of enrollment in the first half of 2021.

New data from VK2809 Phase 2 trial highlighted during podium presentation at EASL 2020. New data from the company's prior 12-week Phase 2 study evaluating VK2809 in the treatment of non-alcoholic fatty liver disease and hypercholesterolemia were highlighted during an oral presentation at the 2020 EASL meeting. The newly reported data demonstrated that patients treated with VK2809 experienced highly durable, statistically significant reductions in liver fat content that were maintained at Week 16, four weeks after completion of dosing in the 12-week study. The results showed that among VK2809-treated patients, the median reduction in liver fat content was 45.4% at Week 16, compared to an 18.7% reduction for placebo (p=0.0053). Additionally, at Week 16, 70.4% of all VK2809-treated patients maintained a response, defined as experiencing 30% relative reduction from baseline in liver fat content (p=0.0083). Of note, 100% of patients receiving 5 mg daily doses of VK2809 maintained a response at Week 16.

Additionally, 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.

The overall results from this study, including these new durability data, as well as the observed consistent efficacy across high risk subgroups, 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.

Initiated Phase 1 trial evaluating VK0214 for the treatment of X-ALD. VK0214 is a novel, orally available thyroid receptor beta agonist being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a devastating disease for which there is currently no therapeutic treatment. To date, findings from in vitro and in vivo studies have demonstrated that administration of VK0214 results in a significant reduction of very long chain fatty acids in both plasma and tissue, key biomarkers of disease, suggesting a potential therapeutic benefit.

During the third quarter, the company advanced this program into clinical development by initiating a Phase 1 first-in-human trial. The Phase 1 trial is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy subjects. The primary objectives of the study include evaluation of the safety, tolerability, and pharmacokinetics of single and multiple oral doses of VK0214, as well as the identification of VK0214 doses for further clinical development in the setting of X-ALD. Upon successful completion of the SAD/MAD study, the company plans in 2021 to advance this program into a proof-of-concept trial in patients with X-ALD.

Balance sheet remains strong with over $255 million in cash. Viking completed the third quarter of 2020 with $255.3 million in cash, cash equivalents and short-term investments.

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 potential treatment of X-linked adrenoleukodystrophy (X-ALD). VK0214 is currently being evaluated in a Phase 1 first-in-human clinical trial. 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.

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, timelines and milestones, including the company's expected timing for the potential initiation and completion of clinical studies in X-ALD for VK0214 and plans for completion of the company's VOYAGE Phase 2b study, as well as the company's goals and plans regarding VK0214, VK2809 and their respective 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.

Contact:

Michael Morneau

Tel: 858-704-4660

Email: mmorneau@vikingtherapeutics.com

Excerpt from:
Viking Therapeutics : Reports Third Quarter 2020 Financial Results and Provides Corporate Update - marketscreener.com

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