Highlights from the Quarter Ended
Pipeline and Recent Corporate Highlights
Initiated Phase 2 VENTURE Trial Evaluating Dual GLP-1/GIP Agonist VK2735 in Patients with Obesity; Results Expected 1H24. VK2735 is a wholly owned dual agonist of the glucagon like peptide-1, or GLP-1 receptor, and the glucose dependent insulinotropic polypeptide, or GIP receptor, for the potential treatment of various metabolic disorders such as obesity, non-alcoholic steatohepatitis (NASH), and certain rare disorders.
During the first quarter of 2023, the company announced positive results from a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735, which demonstrated that treatment with VK2735 was safe and well-tolerated following weekly dosing for 28 days in healthy obese volunteers. In the SAD portion of the Phase 1 study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic profile. Following single subcutaneous doses, VK2735 demonstrated a half-life of approximately 170 to 250 hours and excellent therapeutic exposures.
In the 28-day MAD portion of the study, VK2735 demonstrated encouraging safety and tolerability, and positive signs of clinical activity. All cohorts receiving VK2735 experienced 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.
VK2735 also demonstrated encouraging safety and tolerability following repeated dosing. The majority of observed adverse events (98%) were reported as mild or moderate, and the majority of gastrointestinal (GI)-related adverse events (99%) were also reported as mild or moderate.
These results were featured earlier this month in an oral presentation at ObesityWeek, the annual meeting of the
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