Viking Therapeutics Initiates Phase 1 Trial of VK3019
Viking Therapeutics announced the initiation of a Phase 1 single ascending dose, or SAD, clinical trial of VK3019, an investigational dual amylin and calcitonin receptor agonist, or DACRA. VK3019 is being developed as a potential treatment option for weight loss. The study initiation follows the filing and clearance of VK3019's investigational new drug, or IND, application with the FDA. The Phase 1 trial is a randomized, double-blind, placebo-controlled SAD study in healthy adults with BMI greater than or equal to30. The primary objectives of the study include evaluating the safety, tolerability, and pharmacokinetics of single subcutaneous doses of VK3019. Exploratory pharmacodynamic assessments include evaluations of changes in body weight after a single-dose administration. Preclinical data from Viking's internally developed DACRAs showed impressive effects on body weight, food intake, and metabolism in healthy rats and diet-induced obese, or DIO, mice compared to control-treated animals. Results showed Viking's DACRAs reduced food intake in lean rats within 0 to 72 hours after a single dose. At 72 hours, these compounds reduced body weight by up to 8% compared to controls. In addition to the Phase 1 trial of VK3019, Viking is currently conducting the Phase 3 VANQUISH studies of subcutaneous VK2735, a dual agonist of the glucagon-like peptide 1, or GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP, receptors, in patients with obesity or who are overweight. In parallel with the development of a subcutaneous formulation, Viking is advancing an oral tablet formulation of VK2735. If successful, oral VK2735 would represent the first oral dual agonist to reach the market. The company believes the availability of both oral and injectable formulations is a key differentiating feature of VK2735, compared with competitive agents, as no other dual or triple agonist is currently available in both formulations. Using the same active ingredient across formulations may also reduce the risk of unexpected side effects compared with switching between therapies that do not share the same active agent. The company plans to initiate a Phase 3 trial to evaluate oral VK2735 for the treatment of obesity and overweight later this year. Based on VK2735's promising efficacy and differentiated pharmacokinetic, or PK, profile, the company is evaluating a range of novel dosing regimens for both the induction and the long-term maintenance of weight loss. The company expects to report the results of the study in 3Q.
