Tuesday, Viking Therapeutics released Phase I results for its weight-loss candidate VK2735, which demonstrated a good safety and tolerability profile and resulted in significant weight reductions.
Pictured: Person stepping on a scale/Courtesy, Getty Images
Tuesday, Viking Therapeutics released Phase I results for its weight-loss candidate VK2735, which demonstrated a good safety and tolerability profile and resulted in significant weight reductions.
Administered subcutaneously, VK2735 showed promising clinical activity in the study’s 28-day multiple-ascending dose portion, decreasing mean body weight up to 7.8% relative to baseline. When compared against the placebo, Viking’s candidate elicited a significantly better mean body weight reduction of 6%.
VK2735 remained significantly better than the placebo until the follow-up at 43 days, according to Viking’s press announcement.
Following the data drop, company shares surged 39% in premarket trading Tuesday.
In the study’s single-ascending dose portion, VK2735 displayed an encouraging safety and tolerability profile, with 98% of observed side effects classified as either mild or moderate in severity.
One patient treated with VK2735 developed acute gallstone obstruction, classified as a serious adverse event. There were no hypoglycemic episodes reported.
While participants in the study were given high doses of VK2735 for a short time, the candidate’s effects showed no signs of plateauing, said Brian Lian, Ph.D., CEO, Viking, in a statement. The company plans to explore longer treatment windows in a Phase II trial, which it expects to launch in mid-2023.
The same day, Viking also announced the assessment of a novel oral formulation of VK2735. Results are expected later this year.
VK2735 is a dual agonist of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, which are well-validated weight-loss targets. For instance, semaglutide, marketed by Novo Nordisk as Ozempic, Wegovy and Rybelsus, works via the former pathway, while Lilly’s Mounjaro (tirzepatide) acts on the latter receptor.
If VK2735 makes it through the clinic and to the market, it will put Viking in direct competition with these heavy hitters in the weight-loss space.
Mounjaro won FDA approval in May 2022 for Type II diabetes. It was launched shortly afterward by Lilly. The drug raked in $482.5 million over approximately half a year.
Novo’s weight-loss portfolio is likewise an imposing industry presence, and the company expects this business to hit around $3.6 billion in sales by 2025. In 2022, Rybelsus sales increased by 134% and Ozempic increased by 77%. Wegovy, along with its other obesity drug Saxenda (liraglutide injection), grew by 101%.
