Viking Therapeutics Announces Positive Top-Line Results from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol

– The Study Achieves Primary Endpoint, Demonstrating Statistically Significant Reductions in LDL-C in Patients Receiving VK2809

 – 57% to 60% Median Liver Fat Reduction Observed in VK2809-Treated Patients

 – 77% to 91% of VK2809-Treated Patients Experienced ≥ 30% Reduction in Liver Fat Content

– VK2809 is Safe and Well-Tolerated with No observed severe adverse effects (SAEs)

Viking Therapeutics (VKTX), which is a clinical-stage biopharmaceutical company focused on   developing novel therapies for metabolic and endocrine disorders, announced positive top-line results from a 12-week Phase 2 study of VK2809, in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C).

The study achieved its primary endpoint. Patients receiving VK2809 demonstrating statistically significant reductions in LDL-C compared with placebo.

The secondary endpoint was also achieved, with VK2809-treated patients experiencing statistically significant reductions in liver fat content compared with placebo.

An abstract describing the results has been submitted for consideration for presentation at the annual meeting of the American Association for the Study of Liver Diseases (AASLD), scheduled for November 9-13, 2018, in San Francisco, CA.

Top-Line Study Results

Reduction in LDL-C

– VK2809-treated patients had a statistically  significant reductions in LDL-C of 20% or more, versus placebo-treated patients.

– VK2809 demonstrated statistically significant improvements in other lipids, including atherogenic proteins apolipoprotein B and lipoprotein (a).

Reduction in Liver Fat Content

– Patients receiving VK2809 experienced statistically significant reductions in liver fat content.

Assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF), relative to placebo after 12 weeks of treatment.

VK2809 was well-tolerated in this study.  Gastrointestinal-related side effects such as diarrhea and nausea were numerically higher in placebo-treated patients relative to VK2809-treated cohorts.

Brian Lian, Ph.D., chief executive officer of Viking said, “VK2809’s effect on liver fat at 12 weeks appears to exceed all other oral agents currently in development for NASH, supporting our view that VK2809 has a best-in-class profile. Based on published data from multiple studies, we anticipate that these liver fat reductions would result in longer-term histologic benefit.  In addition, the improvement in lipid parameters observed in this study suggests potential benefits in cardiovascular health, an important consideration in this population.  We look forward to pursuing further development of VK2809 in NASH.”

For detailed study design and other information Read the firm’s press release by clicking at the following here.

The Product

VK2809 is a small molecule orally available agonist of the thyroid beta receptor (TRβ) that possesses selectivity for liver tissue. The product is also an agonist to the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders.

The drug belongs to a family of novel prodrugs, which are cleaved in vivo to release potent thyromimetics.  Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression genes associated with lipid metabolism and clearance.

The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with Glycogen storage disease type Ia (GSD Ia). 

Viking Therapeutics, Inc.

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing  therapies for metabolic and endocrine disorders.

Viking’s clinical programs include:

VK5211, an orally available, non-steroidal selective androgen receptor modulator.  In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo.

VK2809: Read Above

VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.

Additional programs include novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.  

Prohost Observations

Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, including those noted above. These molecules are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.

The news is definitely refreshing and important as it announces improvement in the treatment of Non-Alcoholic Fatty Liver Disease. As we reiterated and will further elaborate in the upcoming Prohost Letters as to why we pick some biotech firms but not others. We are in an era where the attention should be on firms that bring the future into today. These firms have the capabilities to create therapeutics or design approaches to treatments that can improve on the currently marketed products.

Our favorite picks now are firms that can improve the efficacy and safety of currently marketed products and those firms that have investigational products that act on the root-cause of diseases, including the disease causing genes.

The stock is trading at $18.75. UP $8.42 with a market cap of $1.14 billion. A 52-week-high at $24 and a 52-week-low at $1.18.

We will post an article, under Today’s Highlights, after market hours today. 

It will explain and comment on news from CRISPR Therapeutics about the unlimited uses of CRISPR gene editing in improving breakthrough treatments and much more.