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Viking Therapeutics Liver Candidate Passes Test, Shares Soar

Shares of Viking Therapeutics Inc.VKTX soared more than 87% yesterday on favorable top-line data from a phase II study, evaluating its novel liver-selective thyroid receptor beta agonist, VK2809, for treating non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C).

The stock has skyrocketed 379.3% year to date versus the industry's decrease of 5.9%.

The phase II study on VK2809 met the primary endpoint by demonstrating statistically significant reductions in LDL-C or "bad cholesterol" levels by more than 20% in comparison to placebo. The study also met the secondary endpoint by significantly lowering the liver fat content after 12 weeks of treatment versus placebo.

The median change in liver fat was 58.1% for patients administered with VK2809 as compared to 8.9% for placebo. The percentage of patients having achieved at least 30% reduction in liver fat was 83.3% in the VK2809 arm compared with placebo's 18.2%.

Data from the study showed that VK2809 was well-tolerated with no serious adverse events being reported. Viking Therapeutics CEO Brian Lian said that the quantum of liver fat and bad cholesterol reduction observed in the study shows VK2809 to probably have potential for treating patients with non-alcoholic steatohepatitis (NASH), who stand at the risk of liver fibrosis progression and cardiovascular disease.

Viking Therapeutics remains on track for further development of VK2809 with respect to NASH. The company is also planning to evaluate the candidate in a phase I study for treating patients with glycogen storage disease type Ia (GSDIa).

However, the NASH space remains highly competitive with several companies developing respective candidates for this indication. Late in May 2018, Madrigal Pharmaceuticals MDGL reported positive top-line, 36-week results from a phase II program on patients with biopsy-proven NASH. Findings from the evaluation showed that the company's MGL-3196 candidate achieved a higher reduction in NAFLD activity score (NAS) and greater NASH resolution in patients with 30% or more liver fat decrease achievement at week 12.

Biotech giant Gilead Sciences GILD is also foraying into the emerging NASH domain with its late stage candidate, selonsertib, to combat the persistent decline in its one-time lucrative HCV business. In April, the company announced some encouraging data from a proof-of-concept study of experimental combination therapies for patients with advanced fibrosis due to NASH.

Other companies like Allergan, plc AGN , Intercept Pharmaceuticals, Inc. and Conatus Pharmaceuticals Inc. are also developing treatments for NASH.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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