89bio's NASH Candidate Shows Improvement In Disease Severity, Cardiovascular Health

89bio Inc ETNB announced topline results from a cohort of 20 patients (Cohort 7) in the Phase 1b/2a proof-of-concept study evaluating pegozafermin (formerly BIO89-100) for nonalcoholic steatohepatitis (NASH).

• The results show that 63% of patients achieved a two-point or greater improvement in disease severity without worsening fibrosis (primary endpoint). 
• 89bio also said 74% of patients achieved the two-point improvement alone.
• NASH resolution without worsening of fibrosis was observed in 32% of patients, and 47% experienced NASH resolution or fibrosis improvement.
• 89bio also reported that pegozafermin improved a series of cardio-metabolic measures such as glycemic control, lipids, and body weight.
• No adverse events have been reported, and one patient has discontinued due to the treatment.
• The Company is evaluating pegozafermin in ENLIVEN Phase 2b trial, including 200 patients with a follow-up biopsy performed after 24 weeks of treatment. 
• The therapy is also being tested in patients with severe hypertriglyceridemia in ENTRIGUE Phase 2 trial. 
• The trials are expected to read out in 1H of 2023 and 2H of 2022, respectively.
• As per the new sub-analysis presented at The Liver Meeting 2021, pegozafermin treatment reduced spleen volume by an average of 11.8% in NASH patients.
• Price Action: ETNB shares are up 2.81% at $9.87 during the premarket session on the last check Tuesday.