89bio, trying to rise from ashes of NASH failures, posts gains in disease severity, cardiovascular health in small data set

89bio is climbing over the rubble of fallen nonalcoholic steatohepatitis (NASH) treatments with new top-line data from a limited number of patients that show its candidate spurred improvements in disease severity based on several measures.

Pegozafermin, previously known as BIO89-100, is being tested in a phase 1b/2a trial in NASH patients who have liver fibrosis in stages F2 or F3, the stages before cirrhosis. Patients received the therapy once a week for 20 weeks. The data come from 19 out of 20 patients in an expansion cohort who received end-of-treatment biopsies to confirm results.

The results show that 63% of patients achieved a two-point improvement in disease severity without fibrosis worsening, which was based on a scale developed to assess nonalcoholic fatty liver diseases. This was the main goal of the trial. 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.

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89bio also reported that pegozafermin improved a series of cardio-metabolic measures such as glycemic control, lipids and body weight, all of which can be crucial to the management of NASH patients.

The full study features 83 patients, and 89bio reported that safety and tolerability has been steady in the larger group. No adverse events have been reported, and just one patient has discontinued due to the treatment.

Expectations for 89bio’s top-line results were high, as so many companies have crashed in front of them. Bristol Myers Squibb recently abandoned a midstage asset after getting a look at early phase 2b data. The Big Pharma is continuing on with another NASH candidate called Hsp47.

Metacrine walked away from a phase 2 treatment in October after a mixed bag of results from a trial. Enanta Pharmaceuticals did the same that month.

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That left 89bio, as well as Akero, to turn up results that could finally lead to a treatment for the disease, which causes fat to build up in the liver, resulting in inflammation and damage.

89bio is evaluating pegozafermin in a phase 2b trial called ENLIVEN that will include 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 a phase 2 trial called ENTRIGUE. The trials are expected to read out in the first half of 2023 and the second half of 2022, respectively.