Viking Therapeutics Announces Initiation of Phase 1 Clinical Trial of VK2735, Company's Lead Dual GLP-1/GIP Receptor Agonist

SAN DIEGO, Jan. 10, 2022 /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 initiation of a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2735 is in development for the potential treatment of various metabolic disorders.

The Phase 1 trial is a randomized, double-blind, placebo-controlled, SAD and MAD study in healthy adults. The primary objectives of the study include evaluation of the safety and tolerability of single and multiple doses of VK2735 delivered subcutaneously, as well as the identification of VK2735 doses suitable for further clinical development. Study investigators will also evaluate the pharmacokinetics of single and multiple doses of VK2735. Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content after four weeks of once-weekly administration.

Viking selected VK2735 from a series of internally developed dual GLP-1/GIP receptor agonists evaluated as part of a program focused on the development of best-in-class therapies for metabolic diseases. The results of certain in vivo studies from this program were recently presented at ObesityWeek^® 2021, highlighting the promising effects observed following treatment with VK2735 and other compounds from the series. Data demonstrated improvements in the metabolic profile of diet-induced obese (DIO) mice treated with Viking's compounds as compared to control cohorts.

Weight loss, glucose control, and insulin sensitivity were enhanced following treatment with the Viking dual agonists compared to the effects observed with the GLP-1 mono-agonist semaglutide, when administered at the same dose for the same time period. These results suggest that the addition of GIP receptor activity improves upon the effects achieved with activation of the GLP-1 receptor alone. In separate studies, the effect sizes observed with the Viking series of dual agonists were found to be similar to those observed following treatment with tirzepatide, a dual GLP-1/GIP receptor agonist currently in clinical development. Reductions in liver fat content were generally numerically larger among animals treated with Viking compounds relative to liver fat reductions observed among semaglutide or tirzepatide-treated animals. Based on the results from these and other preclinical studies, the company selected VK2735 as the lead candidate from this program.

"The initiation of clinical development with VK2735 is an important milestone for Viking, as it represents our first internally developed program to reach the clinic and serves to further enhance our position as a leader in the development of novel therapeutics for metabolic disorders. There is growing excitement around the therapeutic promise of single agents designed to target multiple metabolic receptors, and preclinical data thus far suggest that VK2735 has best-in-class potential as a dual GLP-1/GIP agonist. We look forward to completing this initial clinical trial and expect to report topline results later this year," said Brian Lian, Ph.D., chief executive officer of Viking. "VK2735 is the third compound to enter active clinical development at Viking, joining our most advanced program VK2809, a novel thyroid receptor beta agonist in a Phase 2b study in NASH, and VK0214, a second novel thyroid receptor beta agonist in a Phase 1b study in X-linked adrenoleukodystrophy."

About GLP-1 and Dual GLP-1/GIP Agonists

Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic^®, Rybelsus^®, and Wegovy^®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that is currently in clinical development.

About Viking Therapeutics, Inc.

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel 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 2a 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's second clinical candidate is 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 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD. The company's third clinical candidate is VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. VK2735 is currently being evaluated in a Phase 1 clinical trial. The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including VK2809 and VK0214, 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, timelines and milestones, as well as the company's goals and plans regarding its preclinical programs, including those targeting incretin receptor agonists, and their 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 VK2735, VK0214, VK2809, and the company's other incretin receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; 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, 2020, 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.

SOURCE Viking Therapeutics, Inc.