On December 16, 2022, The Arctic Aurora LifeScience and Arctic Aurora Biotech Select portfolio company Madrigal Pharmaceuticals released positive Phase 3 data in patients with the fatty liver disease known as NASH (Nonalcoholic Steatohepatitis). At time of writing, mid market-day after the result announcement, Madrigal stock is trading approximately 250% up. NASH is characterized by liver buildup of fat, inflammation, and fibrosis – scarring of the liver tissue. In its end-stage fibrosis develops into cirrhosis, where there is little or no healthy tissue left in the liver, which is a life-threatening condition often requiring liver transplant.

The major underlying cause of NASH is obesity and hence the disease represent a large healthcare burden on society. It is estimated that 15 to 30 million people in the US have NASH, but the rate of diagnosis is currently low, with one reason being the lack of good treatment alternatives. Something that looks to change with Madrigal’s NASH data.

In the Phase 3 study, the candidate drug resmetirom was tested in two doses and compared to a group of patients that received placebo. 26% and 30% of the patients in the two drug arms experiences resolution of NASH, compared to 10% with placebo. Those results were fairly expected following Madrigal’s previous Phase 2 results with resmetirom. However, the drug candidate also showed a more unexpected statistically significant improvement on the tougher endpoint of fibrosis reduction. The company now intends to file for an accelerated approval with drug regulators, and if approved, resmetirom will be the first dedicated NASH drug approved.