VK 2735 data raise best-in-class expectations- Viking Therapeutics
In a small Phase 1 study, Viking’s once-daily oral VK 2735 led to dose-dependent reductions in weight with greatest weight loss — an average 6.8% at 28 days — achieved in the highest of the eight doses tested. The results were presented during the ObesityWeek conference in San Antonio. Viking said it plans to start a Phase II test of the tablet by the end of this year.
Viking designed VK 2735 to target and activate the GLP-1 and GIP receptors, the same receptors targeted by Eli Lilly’s injectable metabolic disorder drug tirzepatide, which is marketed as Zepbound for weight management. Viking has reached clinical testing with injectable and oral versions of its drug candidate.
Recently, Viking reported preliminary Phase 1 data for oral VK 2735 showing an average placebo-adjusted weight loss of 3.3% after 28 days. In those results, the highest of the five doses tested was 40 mg. The latest results add data for 27 total patients — nine in each of three additional dose groups. The average 6.8% weight reduction at 28 days was in the 100 mg cohort. Despite the higher doses in these cohorts, the study drug continued to be safe and well tolerated by patients. While gastrointestinal side effects are a known complication of currently available obesity meds, Viking reported that adverse events for oral VK 2735 were classified as mild to moderate. Viking said weight loss persisted as observed in follow-up visits through day 57. Based on a preliminary evaluation of the trajectory of weight loss at multiple dose levels, the company believes continued treatment beyond four weeks may provide further reductions in weight.
Presentation of these results at Obesity Week included new pharmacokinetic data showing all patients who received the study drug maintained the majority of their weight loss four weeks after receiving their last dose of the drug in the clinical trial. Viking said it believes these results show the injectable drug could be dosed once-monthly as a maintenance treatment.
VK 2735 is part of a growing class of drugs that work by mimicking hormones in the gut to spark a range of metabolic effects. Novo Nordisk’s Wegovy targets and activates the GLP-1 receptor. The Viking drug is an agonist of both the GLP-1 and GIP receptors. The preliminary results are from a placebo-controlled Phase II clinical trial that tested four doses of the Viking drug, administered as a once-weekly injection. The study enrolled 176 adults who are obese or overweight with at least one weight-related co-existing condition. The main goal was to measure the percent change in body weight after 13 weeks.
Viking said the statistically significant weight loss was observed for all doses starting at week one and continuing throughout the course of the 13-week study. Furthermore, up to 88% of participants in the treatment groups achieved 10% or greater weight loss compared with just 4% of those in the placebo arm. The Viking drug was safe and well tolerated