Novel NAFLD drug dosed for first time, phase 2 trial begins

Viking Therapeutics Inc. announced its orally available VK2809 was dosed in its first patient as part of a phase 2 clinical trial. VK2809 is an original small molecule thyroid receptor agonist that retains selectivity for liver tissue and beta receptor subtype.

About 80 patients with nonalcoholic fatty liver disease and higher than normal LDL cholesterol will receive either VK2809 or placebo once per day for 12 weeks, followed by a 4-week off-drug phase. Evaluation of VK2809’s tolerability, safety and effectiveness vs. placebo will serve as the primary endpoint, with changes in liver fat content, inflammatory markers and triglycerides serving as secondary and exploratory endpoints, according to a press release.

“This study will be critical in validating VK2809’s unique liver-targeted mechanism of action, which we believe provides differentiated benefits by simultaneously reducing hepatic steatosis, an important driver of nonalcoholic steatohepatitis, and improving plasma lipid levels,” Brian Lian, PhD, chief executive officer, Viking, said in a press release. Earlier studies showed VK2809 leads to distinct reductions in LDL cholesterol, triglycerides, and atherogenic proteins in humans, and made accelerated histologic advances in animal models with hepatic steatosis, he added.

According to the press release, these characteristics suggest an extremely distinguished therapeutic profile pertaining to medications currently available for patients with hypercholesterolemia and diseases such as NASH. – by Janel Miller

Disclosure: Lian is employed by Viking.