Viking Therapeutics, Inc. (NASDAQ: VKTX) jumps over 4% in pre trading session on Wednesday as the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical study of VK2735 that the business conducted has shown encouraging findings, according to the company. The substance is a new dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) receptors that is being researched as a potential therapy for a variety of metabolic problems. The business intends to start a Phase 2 investigation of VK2735 in individuals with obesity in the middle of 2023 based on these Phase 1 results.
VK2735 showed promising safety and tolerability as well as a predicable pharmacokinetic (PK) profile in the study’s SAD section. After a single subcutaneous injection, VK2735 showed good therapeutic exposures, a half-life of around 170 to 250 hours, and a Tmax (time to reach maximum plasma concentration) ranging from roughly 75 to 90 hours.
VK2735 showed excellent indicators of clinical efficacy and acceptable tolerability throughout the 28-day MAD phase of the research. With a range of up to 7.8%, all cohorts receiving VK2735 showed decreases in mean body weight from baseline. Moreover, VK2735-treated cohorts showed up to 6.0% lower mean body weights than placebo. 21 days after the final dosage of VK2735 was provided, at the Day 43 follow-up time point, statistically significant changes compared to placebo were either maintained or improved. The business thinks that the study’s tolerability outcomes show that greater dosages may be obtained with longer titration windows. In the future Phase 2 experiment, Viking intends to assess additional dosage escalation.
According to Brian Lian, Ph.D., chief executive officer of Viking, “This Phase 1 findings demonstrate VK2735’s favorable early profile, with good safety, tolerability, and positive benefits on body weight.” “The preliminary findings point to outstanding clinical qualities, acceptable tolerability, and a mean weight loss of up to 18 pounds from baseline. No evidence of plateau were seen, despite the fact that patients in this trial were only given greater dosages for a brief period of time. In the Phase 2 trial, we look forward to investigating greater dosages over a longer treatment window.”