[Updated, 2:45 pm ET, see below] There is another update today in the competitive race to treat nonalcoholic steatohepatitis (NASH), an increasingly common liver disease with no FDA-approved therapies. Viking Therapeutics released preliminary results from a Phase 2 study suggesting its experimental drug might impact some of the disease’s many dangerous effects on the liver.
San Diego-based Viking (NASDAQ: [[ticker:VKTX]]) reported that its drug, VK2809, hit its goals in a 12-week, Phase 2 trial of patients with nonalcoholic fatty liver disease (NAFLD) and high levels of LDL or “bad” cholesterol. NAFLD is one of the most common causes of liver disease in the U.S., according to the National Institute of Diabetes and Digestive and Kidney Diseases. NASH is the dangerous form of NAFLD that can lead to liver cancer and cirrhosis, but most patients with NAFLD don’t develop NASH.
While the Viking drug reduced liver fat and cholesterol in NAFLD patients—the goals of this and other trials testing NASH drugs from other companies—it’s not yet clear whether it will do the same in patients with the liver-damaging form of the disease. Nonetheless, Viking has been eying NASH as a target for its drug. Last year, the company released promising results from a preclinical study testing the drug as a NASH treatment. Now, Viking says its drug holds promise for treating NASH because its drug led to larger reductions in liver fat than other NASH drugs in development.
According to the preliminary Phase 2 results, the Viking drug reduced patients’ cholesterol levels compared to placebo—the study’s main goal. The company also reported that the drug met a key secondary objective by cutting liver fat. Investors liked the news, boosting shares of Viking 89 percent Tuesday morning.
In the study, Viking said patients who received one of two different doses of VK2809 had a median reduction of either 56.5 percent (for a dose of once every two days) or 59.7 percent (daily dose) in liver fat, compared to an 8.9 percent reduction for placebo patients.
Additionally, 76.9 percent of patients on the less frequent dose and 90.9 percent of those on the daily dose had at least a 30 percent reduction in liver fat, compared to 18.2 percent for placebo patients.
[Updated with analyst comments] That’s important. Viking hopes to show that its drug can help people with NASH, too, and a 30 percent or greater reduction in liver fat has been associated with a positive effect on NASH in trials of rival drugs, wrote Raymond James analyst Steven Seedhouse in a note Tuesday. In a statement, Viking CEO Brian Lian said that the drug’s effect on liver fat after 12 weeks of treatment “appears to exceed all other oral agents currently in development for NASH, supporting our view that VK2809 has a best-in-class profile.”
Viking also reported no serious side effects from its drug. Most of those effects related to the gut, and included diarrhea and nausea. Those effects were mostly observed in patients who received the placebo, Viking said. More safety data will be presented at an upcoming medical conference.
Viking’s drug is what’s known as a liver-selective thyroid beta agonist. It’s the same type of drug as MGL-3196, from Madrigal Pharmaceuticals (NASDAQ: [[ticker:MDGL]]). Madrigal reported Phase 2 results in May showing that its drug cut patients’ liver fat, compared to placebo, after 12 weeks of treatment. The Madrigal drug also hit statistical significance on a variety of goals relevant to NASH after 36 weeks of treatment. Madrigal’s stock price more than doubled on those results. But early Tuesday, Madrigal shares dipped nearly 15 percent.
VK2809 “clearly looks like the more potent” of the two drugs, Seedhouse wrote. “We see the only advantage retained by Madrigal at this point being time-to-Phase 3.”
A number of companies are also developing potential NASH treatments. Cambridge, MA-based Akero Therapeutics launched in June with $65 million in Series A financing to advance a drug licensed from Amgen (NASDAQ: [[ticker:AMGN]]) into Phase 2 testing. Intercept Pharmaceuticals (NASDAQ: [[ticker:ICPT]]), Gilead Sciences (NASDAQ: [[ticker:GILD]]), and Bristol-Myers Squibb (NYSE: [[ticker:BMS]]) all have NASH drug candidates in Phase 2 or 3 studies.
Viking said that an abstract describing the results has been submitted for consideration for the annual meeting of the American Association for the Study of Liver Diseases, which is scheduled for Nov. 9 to 13 in San Francisco.
Frank Vinluan contributed to this report.
Image by Wikimedia user Nephron via a Creative Commons license
