- Shares in San Diego-based Viking Therapeutics more than doubled at one point on Tuesday, swelling its market capitalization by nearly $800 million on news the biotech's experimental liver disease drug succeeded in a mid-stage study.
- Results from the small Phase 2 trial showed Viking's treatment significantly reduced liver fat in patients with non-alcoholic fatty liver disease, a condition considered a precursor to the more damaging non-alcoholic steatohepatitis, or NASH.
- While early, the data appeared competitive to that of a rival therapy in development for NASH by Madrigal Pharmaceuticals, shares in which fell more than 13%. No drugs are currently approved to treat the disease, which is estimated to affect millions of Americans.
Tuesday's market reaction to Viking's data hints at the level of interest in drugmakers developing treatments for NASH.
Sometimes referred to as a "silent disease," NASH is characterized by liver inflammation due to excessive build-up of fat. Over time, it can progress to scarring and cirrhosis. Estimates vary widely, but it's thought to affect between 3% and 12% of American adults.
Since 2014, when data from a biotech called Intercept Pharmaceuticals widely impressed, market observers have picked the condition as the next large market opportunity for liver-disease focused companies.
A handful of drugmakers, including Intercept, Madrigal and Gilead Sciences, are furthest along in advancing experimental treatments through clinical testing. Viking's data, though, suggest the lesser-known biotech might be in the conversation as well.
After 12 weeks, treated patients with non-alcoholic fatty liver disease experienced a significant drop in liver fat of 58%, compared to about 9% for those given placebo.
More than 80% of the 31 patients on Viking's drug saw a greater than 30% reduction in liver fat versus only 18% of the 14 patients in the control arm. Previous work by Viking suggested the 30% mark was associated with a greater chance of a histological response in NASH, the company said.
Viking's drug, called VK2809, also led to greater reduction of LDL-C, or "bad" cholesterol than did placebo. No serious adverse events were reported by the company.
The results appear to compare favorably to the liver fat lowering posted by Madrigal's experimental drug MGL-3196, which works by a similar mechanism. Cross-trial comparisons, however, are challenging and Madrigal has data stretching out through 36 weeks that's supported by liver biopsy results.
"There are caveats and [Viking's] data is still early [versus] peers," Jefferies analyst Michael Yee wrote in a Tuesday note to investors, indicating further study would be needed before Viking could begin Phase 3 testing.
Viking, though, is bullish on its candidate and believes the data disclosed Tuesday put VK2809 in the running alongside its potential competitors.
"VK2809's effect on liver fat at 12 weeks appeared to exceed all other oral agents currently in development for NASH, supporting our view that VK2809 has a best-in-class profile," company CEO Brian Lian said in a Sep. 18 statement.
Viking plans to unveil more detailed data in November at the annual meeting of the American Association for the Study of Liver Diseases. Madrigal will also present results for MGL-3196 there.