Viking Therapeutics Inc (NASDAQ:VKTX), a US clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced on Tuesday positive top-line results from the company's Phase 2 clinical trial of the oral tablet formulation of VK2735, its dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
VK2735 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity. The Phase 2 VENTURE-Oral Dosing trial successfully achieved its primary and 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 through 13 weeks of daily dosing with most treatment emergent adverse events (TEAEs) being categorised as mild or moderate.
According to the company, participants receiving once daily doses of the oral tablet formulation of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Participants receiving VK2735 also demonstrated statistically significant reductions in mean body weight relative to placebo, ranging up to 10.9%.
"We are excited to report the top-line Phase 2 study results for the once-daily oral tablet of VK2735," said Brian Lian, Ph.D., Viking CEO. "As in prior studies we observed a clear dose response and impressive weight loss across the 13-week treatment period. The progressive nature of the weight loss curves suggests the potential for further improvement with longer dosing periods. The experimental maintenance arm of this study provides an encouraging signal that supports our belief that transitioning patients from higher doses, injectable or oral, to low oral doses represents a promising approach to weight maintenance therapy. We look forward to exploring this further in an upcoming maintenance dosing study."
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