Viking Therapeutics to Present Phase 2b VOYAGE Study Data on VK2809 in Biopsy-Confirmed NASH/MASH at 75th Liver Meeting 2024

Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company focusing on innovative treatments for metabolic and endocrine disorders, has announced promising results from their Phase 2b clinical trial of VK2809. This study, aimed at patients diagnosed with non-alcoholic steatohepatitis (NASH) through biopsies, will be highlighted at the 75th Liver Meeting 2024 hosted by the American Association for the Study of Liver Disease (AASLD) in San Diego. The presentation is scheduled for November 19, 2024.

The Phase 2b study, named VOYAGE, focused on assessing the efficacy and safety of VK2809, a liver-selective thyroid hormone receptor beta agonist. The trial, which was randomized and placebo-controlled, achieved both its primary and secondary endpoints. Dr. Rohit Loomba, the Director of the NAFLD Research Center and Professor of Medicine at the University of California, San Diego, will present the detailed findings.

VK2809 is designed to target thyroid hormone beta receptors selectively in the liver. This selectivity is crucial because it enables the compound to positively influence lipid metabolism and cholesterol levels through various mechanisms. The trial's success in meeting its endpoints indicates VK2809's potential as a therapeutic option for managing lipid disorders, particularly NASH, which is also known as metabolic dysfunction-associated steatohepatitis (MASH).

Previously, VK2809 had shown similar success in a Phase 2a trial involving patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD). Patients treated with VK2809 experienced significant reductions in LDL-C and liver fat content compared to those who received a placebo. These findings further support the therapeutic potential of VK2809 in addressing lipid and metabolic disorders.

Viking Therapeutics' broader research and development efforts encompass several other promising compounds. The company is also advancing VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2735 is being evaluated for its potential to treat various metabolic disorders, with data from Phase 1 and Phase 2 trials showing a favorable safety profile and signs of clinical benefit. In parallel, Viking is testing an oral formulation of VK2735 in a Phase 1 trial.

Another promising development from Viking is their novel dual amylin and calcitonin receptor agonists (DACRAs) program, targeting obesity and other metabolic disorders. This program represents the company's ongoing commitment to addressing complex metabolic conditions through innovative and effective therapeutic strategies.

In the realm of rare diseases, Viking is developing VK0214, a small molecule selective thyroid hormone receptor beta agonist for X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b trial focused on adrenomyeloneuropathy (AMN), a form of X-ALD, VK0214 was shown to be safe and well-tolerated. It also significantly reduced plasma levels of very long-chain fatty acids (VLCFAs) and other lipids compared to placebo, indicating its potential as a treatment for this rare condition.

Viking Therapeutics continues to leverage its expertise in metabolism to develop first-in-class or best-in-class therapies aimed at improving the lives of patients with metabolic and endocrine disorders. The company's pipeline of innovative compounds underscores its commitment to advancing medical science and offering new hope for individuals affected by these challenging conditions.