89bio has gained a little more confidence in its alcohol-free therapy for steatohepatitis after new data showed the treatment increased levels of important hormones associated with anti-inflammatory and anti-fibrotic activity in the liver.
Biotechnology reported in January that 63% of patients in a phase 1b/2a study of pegozafermin had a two-point improvement in disease severity without worsening fibrosis, based on a scale developed to assess the nonalcoholic fatty liver disease. With this improvement, the therapy achieved the main objective of the study. The study focuses on NASH patients with stage F2 or F3 liver fibrosis, the two stages before cirrhosis.
New study data has now revealed that the drug adiponectin is up 87%, according to a fourth-quarter earnings report released on Thursday. Adiponectin is an insulin-sensitizing hormone that helps regulate lipid and glucose metabolism and has anti-inflammatory and anti-fibrotic effects on the liver.
“These data reinforce our confidence in the potential of pegozafermin to demonstrate a strong beneficial effect in our ongoing and future NASH studies,” said Hank Mansbach, MD Medical Director, 89bio.
The latest data will assist 89bio in developing the Phase 2 Enliven study, which is expected to be read in the first half of 2023.
Analysts were also pleased to receive an update on the Entrigue study, a Phase 2 study just completing enrollment; Evaluation of pegozafermin in patients with very high triglyceride levels. Analysts at RBC Capital Markets said they were confident the therapy would meet the study’s goal of reducing triglycerides by 30%.
A NASH biopsy study previously showed that pegozafermin lowered triglycerides by 26-32%. If this finding can be replicated in the Entrigue trial, 89bio will have a strong case to advance the treatment to a critical Phase 3 trial, according to RBC.
“With stocks trading for liquidity and the market adding almost no value to pegozafermin, we see a significant mismatch in agent profile and opportunity,” RBC said in a statement on Thursday. “We remain buyers”.
Shares of 89 Bio rose slightly by about 6% on Friday morning to $4.26 from a previous close of $3.99. The stock price has been falling steadily since the beginning of the year when 89 trillion was worth about $15 a share.
If pegozafermin does hit the market, RBC believes it has major benefits given its metabolic benefits, including weight loss. The company estimates that this could result in a $450 million opportunity for the sole manifestation of severe hypertriglyceridemia.
NASH is an extremely difficult signal for pharmacies large and small. 89bio offered one of the few glimmers of positive data earlier this year when the first results from a phase 1b/2a expansion cohort were released. The disease thwarted therapeutic efforts by Bristol Myers Squibb, Metacrine, Enanta Pharmaceuticals, and others.