Viking Therapeutics announces results from Phase 1 trial of VK2735

Viking Therapeutics announced results from the company’s Phase 1 single ascending dose and multiple ascending dose clinical trial of VK2735. The compound is a novel dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors in development for the potential treatment of various metabolic disorders. Based on these Phase 1 results, the company plans to initiate a Phase 2 study of VK2735 in patients with obesity in mid-2023. In the SAD portion of the study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic profile. Following single subcutaneous doses, VK2735 demonstrated a half-life of approximately 170 to 250 hours, a Tmax ranging from approximately 75 to 90 hours, and excellent therapeutic exposures. In the 28-day MAD portion of the study, VK2735 demonstrated encouraging tolerability and positive signs of clinical activity. All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.0%. Statistically significant differences compared to placebo were maintained or improved at the Day 43 follow-up time point, 21 days after the last dose of VK2735 was administered. The company believes tolerability data from this study indicate that higher doses may be achieved with longer titration windows. Viking plans to evaluate further dose escalation in the upcoming Phase 2 trial. VK2735 demonstrated encouraging safety and tolerability following repeated dosing. The majority of observed adverse events were reported as mild or moderate. The majority of gastrointestinal related adverse events were also reported as mild or moderate. One serious adverse event was reported in a subject receiving VK2735. A subject with a history of cholelithiasis experienced an SAE of acute choledocholithiasis. Nausea was reported among subjects receiving both VK2735 and placebo. Among subjects receiving VK2735, the majority of reported nausea was characterized as mild. Vomiting was reported in 6/31 VK2735 treated subjects and 1/10 subjects receiving placebo. No subjects were discontinued for nausea, vomiting, or GI adverse events. Despite robust activation of the incretin receptor pathways, no hypoglycemia was reported. The Phase 1 trial was a randomized, double-blind, placebo-controlled SAD and MAD study in healthy adults. The SAD portion of the study evaluated VK2735 in healthy adults, while the MAD portion of the study enrolled healthy adults with a minimum body mass index of 30 kilograms per meter squared. The primary objectives of the study were to evaluate the safety and tolerability of single and multiple doses of VK2735 administered subcutaneously and identify suitable doses for further clinical development. The secondary objective was to evaluate the pharmacokinetics of VK2735 in healthy subjects. The SAD portion of the study evaluated escalating single doses of VK2735. In the MAD portion of the study subjects received VK2735 once weekly for 28 days.