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

Oral Late Breaker Presentation Summarizes Positive Results Including Successful Achievement of Study's Primary and Secondary Endpoints

Data Support VK2809's Best-in-Class Profile Highlighted by Robust Liver Fat Reductions, Histologic Results Demonstrating NASH/MASH Resolution and Fibrosis Improvement, and Promising Tolerability and Safety

SAN DIEGO, Nov. 19, 2024 /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 that final results from the company's Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred to as metabolic dysfunction associated steatohepatitis, MASH) were highlighted in an oral late breaker presentation at the 75th Liver Meeting® 2024, the annual meeting of the American Association for the Study of Liver Disease (AASLD).  The presentation summarized the final 52-week data from the VOYAGE study, showing that VK2809 successfully achieved the trial's primary and secondary endpoints while demonstrating excellent tolerability and promising safety.

Highlights from the oral presentation included:

Reduction in Liver Fat Content at 52 Weeks

Patients receiving VK2809 demonstrated statistically significant reductions in liver fat at Week 12, which was the primary endpoint in VOYAGE.  Importantly, patients receiving VK2809 continued to demonstrate statistically significant reductions in liver fat content at Week 52, with the mean relative change from baseline ranging from 37% to 55%.  The response rate in this study, defined as the proportion of patients experiencing reduction in liver fat ≥30%, ranged from 64% to 88% at Week 52, with all treatment arms demonstrating statistically significant improvement compared to placebo.

Histologic Results at 52 Weeks

On the secondary endpoint of NASH resolution with no worsening of fibrosis, VK2809-treated patients demonstrated NASH resolution ranging from 63% to 75%, compared with 29% for placebo (p