Viking Therapeutics Unveils Phase 2b VOYAGE Study Results of VK2809 in Biopsy-Confirmed NASH/MASH at 75th Liver Meeting 2024

Viking Therapeutics, Inc. (NASDAQ: VKTX), a clinical-stage biopharmaceutical company developing innovative treatments for metabolic and endocrine disorders, recently revealed positive final results from their Phase 2b clinical trial of VK2809. This liver-selective thyroid hormone receptor beta agonist was evaluated in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). The data was presented at the 75th Liver Meeting® 2024, organized by the American Association for the Study of Liver Disease (AASLD).

The 52-week data from the VOYAGE study indicated that VK2809 achieved the trial's primary and secondary endpoints, showcasing excellent tolerability and promising safety.

Key findings from the study include:

Reduction in Liver Fat Content: Patients treated with VK2809 showed statistically significant reductions in liver fat at both Week 12 and Week 52. At Week 52, the mean relative change from baseline in liver fat content ranged from 37% to 55%. Moreover, the response rate, defined as patients with a liver fat reduction of ≥30%, was between 64% and 88% across different treatment arms, all showing significant improvement over placebo.

Histologic Results: For the secondary endpoint of NASH resolution without worsening fibrosis, VK2809-treated patients showed resolution rates between 63% and 75%, compared to 29% for placebo. Among the combined VK2809 groups, 69% achieved NASH resolution. Improvement in fibrosis without worsening NASH was observed in 44% to 57% of VK2809-treated patients, against 34% in the placebo group. Additionally, 40% to 50% of VK2809-treated patients experienced both NASH resolution and fibrosis improvement, compared to 20% for placebo.

Reduction in Plasma Lipids: At Week 52, VK2809-treated patients exhibited placebo-adjusted reductions in LDL-C between 20% and 25%, along with decreases in triglycerides and atherogenic proteins such as apolipoprotein B, lipoprotein (a), and apolipoprotein C-III, all linked to cardiovascular risk. These findings suggest a potential cardioprotective benefit of VK2809.

Safety and Tolerability: VK2809 demonstrated encouraging safety and tolerability throughout the 52-week treatment period, with the majority of treatment-related adverse events being mild or moderate. Discontinuations due to adverse events were minimal and balanced between placebo and treatment groups. VK2809 also displayed excellent gastrointestinal tolerability, with rates of nausea, diarrhea, stool frequency, and vomiting similar to those in the placebo group.

Dr. Rohit Loomba, Chief of the Division of Gastroenterology and Hepatology at the University of California San Diego School of Medicine, commented that the data strongly supports VK2809's therapeutic potential in NASH/MASH, highlighting the significant reductions in liver fat, high rates of NASH resolution, and fibrosis improvements as notable benefits for patients. Additionally, the improvements in plasma lipids reflect a potential long-term cardioprotective effect.

Brian Lian, Ph.D., CEO of Viking, emphasized the significance of VK2809's success, along with ongoing clinical programs like VK2735 in obesity and preclinical programs targeting amylin receptor agonists. These efforts position Viking as a key player in developing innovative treatments for metabolic disorders.

The VOYAGE study was a randomized, double-blind, placebo-controlled, multicenter international trial designed to evaluate the efficacy, safety, and tolerability of VK2809 in patients with biopsy-confirmed NASH/MASH and fibrosis. The study's primary endpoint was the change in liver fat content from baseline to Week 12, and secondary endpoints included histologic changes assessed after 52 weeks of treatment.

VK2809, an orally available, tissue and receptor-subtype selective agonist of the thyroid hormone beta receptor, shows promise for lipid disorders. The Phase 2b VOYAGE study demonstrated VK2809's efficacy in reducing liver fat, improving NASH resolution, and enhancing fibrosis without worsening NASH, establishing its potential as a therapeutic option for metabolic disorders.