Viking Therapeutics has initiated a Phase 1 clinical study to evaluate a novel oral formulation of the company's dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The study, which is an extension of the company's recently completed Phase 1 evaluation of subcutaneously administered VK2735, will evaluate daily oral doses for 28 days. The company believes the results from this study could be available in the second half of 2023.
The Phase 1 trial is a randomised, double-blind, placebo-controlled study in healthy adults with a minimum BMI30kg/m2. The primary objective of the study is to evaluate the safety and tolerability of VK2735 administered as an oral tablet once daily for 28 days. The secondary objective is to evaluate the pharmacokinetics of orally administered VK2735 in healthy subjects. Exploratory pharmacodynamic measures include assessments of changes in body weight and plasma glucose.
"We are excited to announce the initiation of a clinical study with oral VK2735. The injectable formulation has shown great promise in Phase 1 trial results announced earlier today, and we believe our novel tablet formulation represents a significant expansion of the program's overall potential," said Dr Brian Lian, chief executive officer of Viking. "In vivo data to date suggest therapeutic plasma levels of VK2735 may be achieved via oral dosing, and we expect both the subcutaneous formulation and the oral formulation to provide unique benefits to patients. The ability to select either subcutaneous or oral dosage forms of VK2735 creates attractive potential treatment options and further extends the reach of this important programme."
Viking has previously reported results from a 28-day multiple ascending dose Phase 1 study of VK2735 administered subcutaneously, which 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%. The company plans to initiate a Phase 2 study of the subcutaneous formulation of VK2735 in patients with obesity in mid-2023.