Benzinga | Jan 10, 2022 07:05AM EST

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

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(r) 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."