Benzinga - by Vandana Singh, Benzinga Editor.
Tuesday, Viking Therapeutics Inc (NASDAQ:VKTX) released top-line results from its Phase 2 trial of VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders such as obesity.
The Phase 2 VENTURE trial achieved its primary endpoint and all secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo.
Additionally, the study showed VK2735 treatment to be safe and well tolerated, with most treatment-emergent adverse events (TEAEs) being categorized as mild or moderate.
Patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline.
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Patients receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 13.1%.
Statistically significant differences compared to baseline and placebo were observed for all doses starting at Week one and continuing throughout the 13-week treatment period.
Reductions in body weight were progressive throughout the study, with no plateau observed for weight loss at 13 weeks.
All doses of VK2735 also demonstrated statistically significant differences relative to placebo on the key secondary endpoint assessing the proportion of patients demonstrating at least 10% weight loss.
Up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo.
We look forward to progressing this important therapy into further clinical development later this year. Separately, we remain on track to report data from a Phase 1 study of an oral formulation of VK2735 later this quarter,” said Brian Lian, CEO.
A total of 23 patients (13%) discontinued treatment in the study, 5 (14%) in the placebo cohort, and 18 (13%) among VK2735-treated cohorts.
Most TEAEs that were gastrointestinal in nature (95%) were also reported as mild or moderate.
The stock went up as much as 98% in premarket trading on Tuesday
Price Action: VKTX shares are up 56% at $60.02 on the last check Tuesday.
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