89bio gains a little more confidence in NASH treatment with new hormone data

89bio has gained a little more confidence in its non-alcoholic steatohepatitis therapy after new data showed the treatment increased levels of a key hormone linked to anti-inflammatory and anti-fibrotic activity in the liver.

The biotech reported in January that 63% of patients in a phase 1b/2a trial of pegozafermin showed a two-point improvement in disease severity without fibrosis worsening, which was based on a scale developed to assess nonalcoholic fatty liver diseases. With that improvement, the therapy met the trial's main goal. The study covers patients with NASH who have liver fibrosis in stages F2 or F3, the two stages before cirrhosis.

New data from the study has now revealed that the med boosted adiponectin by 87%, according to a fourth-quarter earnings report issued Thursday. Adiponectin is an insulin-sensitizing hormone that can help regulate lipid and glucose metabolism while providing an anti-inflammatory and anti-fibrotic effect in the liver.

“These data increase our confidence in the potential of pegozafermin to show a strong beneficial effect in our ongoing and future NASH trials,” said 89bio Chief Medical Officer Hank Mansbach, M.D.

The latest data will help 89bio develop the phase 2 Enliven trial, which is expected to read out in the first half of 2023.

Analysts were also happy to see an update on the Entrigue trial, a phase 2 study that just closed enrollment; it's examining pegozafermin in patients with severely increased triglycerides. RBC Capital Markets analysts said they're confident that the therapy will meet the trial’s goal of lowering triglycerides by 30%.

Pegozafermin was previously shown to lower triglycerides by 26-32% in a NASH biopsy study. If that result can be replicated in the Entrigue trial, 89bio will have a strong case to advance the treatment to a phase 3 pivotal study, according to RBC. 

“With shares trading around cash and the market ascribing virtually no value to pegozafermin, we see a substantial disconnect versus the agent's profile and opportunity,” RBC said in a Thursday note. “We remain buyers.”

89bio's shares were up slightly Friday morning, rising about 6% to $4.26, compared to a prior close of $3.99. The share price has been declining steadily since the beginning of the year, when 89bio was worth around $15 apiece. 

Should pegozafermin reach the market, RBC sees it having a broad advantage, given its metabolic benefits including weight reduction. This could lead to a $450 million opportunity in just the severe hypertriglyceridemia indication, the firm estimated.

NASH has been an incredibly difficult indication for pharmas big and small. 89bio offered one of the rare glimmers of positive data earlier this year when the first results from the phase 1b/2a expansion cohort were released. The disease has taken down therapeutic efforts from Bristol Myers Squibb, Metacrine, Enanta Pharmaceuticals and others.