89Bio Stock Soared 55% on Phase 2 Liver Disease Drug Trial Data

The 89bio Inc (NASDAQ: ETNB) stock price soared 55% after announcing positive topline data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH).

During the study, both the  30mg weekly (QW) and the 44mg every two weeks (Q2W) met both the primary histology endpoints, with high statistical significance, as stipulated by the U.S. Food and Drug Administration (FDA’s) guidance on statistical analysis and endpoints.

Investors cheered the news, given the rising cases of liver disease among patients who do not consume alcohol globally. The demand for drugs that can treat NASH globally is increasing, and 89Bio is well-positioned to capitalise on this trend. 

The 30mg QW and the 44mg Q2W dose groups both exhibited at least one-stage fibrosis improvement without worsening of NASH (26% and 27%, respectively), which was 3.5 times the placebo rate of 7% and the NASH resolution without worsening the fibrosis (23% and 26%, respectively), was between 12 to 14 times the placebo rate of 2%.

89Bio enlisted the help of three expert blinded pathologies to score the study biopsies for the ENLIVEN study to minimise the risk of bias based on each reader and the inter-reader variability. 

Arun J. Sanyal, MBBS, M.D., Professor at Virginia Commonwealth University, said: “I was pleased to see the impressive results on the critical histology endpoints and non-invasive tests in the ENLIVEN trial. I was especially encouraged by the significant improvement in fibrosis relative to placebo, as fibrosis is a key driver of NASH disease progression, which can lead to cirrhosis and other negative clinical outcomes,” 

Adding: 

“These data are all the more significant given the rigour of the study methodology, including how the biopsies were read to reduce the impact of reader bias and variability. The ENLIVEN study followed a stringent analytical plan consistent with FDA guidance, and the low placebo response rate provides high confidence that this trial showed the true potential treatment effect of pegozafermin.”

89Bio stock had given up most of its gains at writing, but investor interest in the stock remained high, as evidenced by the 3.48 million 89Bio shares that had changed hands at publishing. 

*This is not investment advice. 

89Bio stock price. 

The 89Bio (ETNB) stock price soared 54.99% to trade at $16.94, from Tuesday’s closing price of $10.93.