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Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Dual GLP-1/GIP Receptor Agonist VK2735
Up to 6.0% Placebo-Adjusted Mean Weight Loss (7.8% From Baseline) Observed After 28 Days VK2735 Shown to be Safe and Well-Tolerated in 28-Day Study Phase 2
About this update from Viking Therapeutics, Inc.
[{"type":"text","content":"Up to 6.0% Placebo-Adjusted Mean Weight Loss (7.8% From Baseline) Observed After 28 Days\nVK2735 Shown to be Safe and Well-Tolerated in 28-Day Study\nPhase 2 Trial in Obesity Planned for Mid-2023\nSAN DIEGO, March 28, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive results from the company's Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735. The compound is a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders. Based on these Phase 1 results, the company plans to initiate a Phase 2 study of VK2735 in patients with obesity in mid-2023. \n\n \n \n \n \n \n \n\n \nIn the SAD portion of the study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic (PK) profile. Following single subcutaneous doses, VK2735 demonstrated a half-life of approximately 170 to 250 hours, a Tmax (time to reach maximum plasma concentration) ranging from approximately 75 to 90 hours, and excellent therapeutic exposures.\nIn the 28-day MAD portion of the study, VK2735 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%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.0%. Statistically significant differences compared to placebo were maintained or improved at the Day 43 follow-up time point, 21 days after the last dose of VK2735 was administered. The company believes tolerability data from this study indicate that higher doses may be achieved with longer titration windows. Viking plans to evaluate further dose escalation in the upcoming Phase 2 trial. \n\"These Phase 1 data highlight VK2735's attractive early profile, with encouraging safety, tolerability, and positive effects on body weight,\" said Brian Lian, Ph.D., chief executive officer of Viking. \"The initial data suggest excellent clinical characteristics, with good tolerability and up to approximately 18 p...