Viking Therapeutics Presents Preclinical Data on Novel Dual GLP-1/GIP Agonists at ObesityWeek® 2021

The Company's Dual-Receptor Agonists Demonstrate Potent Weight Loss and Improve Metabolic Profile in Diet-Induced Obese Mice

Company Plans to Initiate First-in-Human Clinical Trial in Coming Months

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Viking Therapeutics, Inc.

Nov 01, 2021, 07:03 ET

SAN DIEGO, Nov. 1, 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 the presentation of preclinical data from a series of internally developed dual agonists of the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors at ObesityWeek^® 2021. The presentations highlight the effects of treatment on body weight and metabolic profile in diet-induced obese (DIO) mice as compared to control cohorts treated with vehicle, the GLP-1 agonist semaglutide, or the dual GLP-1/GIP agonist tirzepatide. The studies are summarized in two poster presentations at the annual meeting of The Obesity Society, being held virtually November 1-5, 2021.

The results of the studies demonstrate that addition of GIP receptor activity improves upon the observed effects resulting from activation of the GLP-1 receptor alone in DIO mouse models. Weight loss, glucose, and insulin effects are enhanced in the Viking series of dual-agonist compounds compared to the effects observed with the GLP-1 agonist comparator, semaglutide, when administered at the same dose for the same time period.

In separate studies, the effect sizes observed with the Viking series of dual agonists were 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 tirzepatide-treated animals.

Highlights from the poster presentations are summarized below.

Poster 206: Novel Co-Agonists of GLP-1 and GIP Receptors Produce Robust Weight Loss in a Rodent Model of Obesity

21-day study comparing a series of novel GLP-1/GIP dual agonists to vehicle and to the GLP-1 agonist semaglutide
Treatment with Viking dual agonists resulted in mean reductions in body weight of up to 27% relative to vehicle (p<0.0001), compared with a mean reduction of 18% among semaglutide-treated animals (p<0.0001 vs. semaglutide)
Treatment with Viking dual agonists resulted in mean reductions in blood glucose of up to 23% relative to vehicle (p<0.0001), compared with a mean reduction of 7% among semaglutide-treated animals (p<0.0001 vs. semaglutide)
Treatment with Viking dual agonists resulted in mean reductions in plasma insulin of up to 57% relative to vehicle (p<0.0001), compared with a mean reduction of 35% among semaglutide-treated animals (p = non-significant vs. semaglutide)

Poster 207: Novel Dual Incretin Receptor Agonists Reduce Body Weight and Improve Metabolic Profile in DIO Mice

14-day study comparing a series of novel GLP-1/GIP dual agonists to vehicle and to the GLP-1/GIP dual agonist tirzepatide
Treatment with Viking dual agonists resulted in mean reductions in body weight of up to 28% (p<0.0001 vs. vehicle) and reductions in plasma glucose of up to 26% (p<0.0001 vs. vehicle). These effects were comparable to those observed among tirzepatide-treated animals (29% and 25% reductions, respectively, vs. vehicle)
Treatment with Viking dual agonists resulted in mean reductions in plasma triglycerides of up to 37% relative to vehicle (p=0.004) compared with a 29% mean reduction among tirzepatide-treated animals (p = non-significant vs. tirzepatide)
Treatment with Viking dual agonists resulted in mean reductions in liver triglycerides of up to 49% relative to vehicle (p=0.01), compared with a 19% mean reduction among tirzepatide-treated animals (p<0.05 vs. tirzepatide)

The results of these and other preclinical studies provide the rationale for Viking's continued advancement of its internal dual GLP-1/GIP agonist development program. The company plans to initiate a first-in-human Phase 1 trial with a lead candidate in the coming months.

"We are excited to report these results, which highlight the potency and promise of these novel compounds," said Brian Lian, Ph.D., chief executive officer of Viking. "These presentations add to the growing body of evidence that supports the targeting of multiple metabolic receptors with a single agent, further enhancing desired metabolic benefits. Our efforts around incretin receptor agonists complement our ongoing clinical studies in NASH, with VK2809, and X-linked adrenoleukodystrophy, with VK0214, where patient enrollment continues. These new dual agonists result from our internal development activities focused on important therapeutic targets and represent an expansion of our pipeline of novel agents for metabolic and endocrine disorders. We look forward to commencing clinical studies with a lead candidate from this program."

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, 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 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 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 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of 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, timelines and milestones, as well as the company's goals and plans regarding its preclinical programs, including those targeting dual 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 VK0214, VK2809, and the company's dual 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.