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‘Super’-responder analysis gives more power to Viking’s fatty liver drug

Researchers Monday presented more complete results from Viking Therapeutics’ 12-week Phase 2 study of VK2809 at The Liver Meeting 2018, after previously announcing in September that the trial had met its primary and secondary endpoints of reducing “bad” cholesterol and liver fat in patients with non-alcoholic fatty liver disease (NAFLD).
The company announced that VK2809 reduced liver fat content by 50% or more in 67% of patients, according to a ‘super’-responder analysis. Previously, the company said up to 91% of patients had achieved a reduction of at least 30%.
Researchers also highlighted benefits in other markers, including atherogenic proteins, and released more data on the medicine’s effect on alanine aminotransferase (ALT) levels in patients up to 16 weeks.
The super responder data is particularly striking for a relatively short trial and offers hope for the subset of NAFLD patients with non-alcoholic steatohepatitis (NASH), said Rohit Loomba, director of the NAFLD Research Center at the University of California at San Diego and presenter of the VK2809 data. Patients with NASH have hepatitis and cell damage in addition to the fat in the liver.
“We would expect that patients who have their liver fat content reduced by more than half may even have a higher likelihood of improvements in liver histology when assessed in a future biopsy-based trial,” Loomba said in statement from Viking.
The presentation reinforced previously announced data that makes it “hard to dispute the potency of VK2809,” Raymond James analyst Steven Seedhouse wrote in a note to investors. The ALT data showing a reduction below placebo and baseline by week 16 after a transient bump in week 1 should be particularly reassuring, he said.
Investors have been concerned about safety issues that ​Seedhouse called theoretical. He said the overall safety and tolerability profile of the medicine “frankly looks fine” and the full release of ALT data reflects positively on Viking’s management and its disclosure policy.
“We are expecting rationality to eventually prevail over unfounded groupthink as it relates to VK2809’s liver safety profile,” Seedhouse said.
Viking CEO Brian Lian said the study results bode well for NAFLD and NASH patients, with the liver safety data out to week 16 suggesting long-term benefits. “Based on these exciting results, we are aggressively moving forward with further clinical studies of VK2809 in NASH, which we expect to initiate in 2019.”