Benzinga | Nov 13, 2020 08:08AM EST

89bio Reports Presentation Of Updated Clinical Data From Phase 1b/2a Study Of BIO89-100 In NASH At American Association for the Study of Liver Diseases Meeting

89bio, Inc. (NASDAQ:ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced updated data from its positive Phase 1b/2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). Previously disclosed topline data demonstrated reductions in liver fat with concurrent beneficial effects on lipids and other metabolic parameters, as well as favorable tolerability, with both weekly and every two-week dosing. New analyses from the trial will be presented today in a late-breaking poster (abstract #LP34) at The Liver Meeting Digital Experience(tm) 2020 of the American Association for the Study of Liver Diseases (AASLD).

"I believe that these data highlight BIO89-100's robust potency in reducing liver fat as assessed by MRI-PDFF over a 12-week period. New analyses of the data demonstrate the strong and significant correlation between relative reductions in MRI-PDFF and serum ALT in patients treated with BIO89-100. Responses on these two measures have been shown to translate into histology improvement and potentially a clinically meaningful benefit in patients with NASH," said Rohit Loomba, MD, MHSc, Director of the UC San Diego NAFLD Research Center and Director of Hepatology at UC San Diego School of Medicine. "We saw a remarkable consistency of results across the sub-populations of biopsy-confirmed NASH and phenotypic NASH (PNASH) patients enrolled in the trial. Baseline characteristics were similar across these sub-populations and BIO89-100 treatment resulted in similar reductions in liver fat, ALT, and triglycerides."

"We are moving forward with a comprehensive clinical development program designed to build upon the promising results from BIO89-100's Phase 1b/2a trial, which includes plans to initiate a Phase 2b study in the first half of 2021 and an open-label paired biopsy histology cohort in the near-term. Today's data are encouraging for these planned studies as we believe they demonstrate BIO89-100's compelling risk-benefit profile as a leading FGF21 analog in a class that could become a key part of the NASH treatment paradigm," said Rohan Palekar, Chief Executive Officer, 89bio.

A copy of the poster presentation, entitled "BIO89-100 Demonstrated Robust Reductions in Liver MRI-PDFF, Favorable Tolerability and Potential for Every 2 Weeks Dosing in a Phase 1b/2a Placebo-Controlled, Double Blind, Multiple Ascending Dose Study in NASH," is available on the AASLD website and is also available for download via the 89bio website.

The data presented show:

* Similar reductions in liver fat, ALT and triglycerides between biopsy-confirmed NASH and PNASH patients treated with BIO89-100 and, importantly, their similar baseline characteristics underscored the consistency across these two sub-populations of patients enrolled in the trial.

* Pharmacokinetics of BIO89-100 demonstrated dose proportional PK.

* Positive and highly significant correlation (r=0.540, p<0.001) between relative reduction in liver fat by MRI-PDFF and ALT reduction at Week 13.

* Treatment with BIO89-100 (N=81) resulted in significant reductions in liver fat on MRI-PDFF at Week 13 across all dose groups vs. placebo, with up to 70% and 60% relative reductions for the 27mg-QW and 36mg-Q2W dose groups vs. placebo, respectively (p<0.001).

* Significant proportion of patients responded to therapy with up to 88% and 71% of patients achieving a ?30% and a ?50% reduction in liver fat vs. baseline, respectively.

* Significant benefit in markers of liver injury and fibrosis, with up to 44% reduction in ALT and a 35 Units/Liter (U/L) decrease in patients with high ALT was observed.

* Significant improvements were also observed in triglycerides. Reductions in TGs was more pronounced in patients who had higher levels of TGs at baseline.

* Improvements were also noted across the spectrum of metabolic marker data vs. placebo for the 27mg QW dose group including HOMA-IR, glucose, HbA1c, weight (p<0.05) and adiponectin (p<0.001).

* BIO89-100 was well-tolerated across all doses with no deaths or serious adverse events related to treatment and a low incidence of treatment-related adverse events (TRAEs) that occurred in ? 10% of patients. Low frequency of gastrointestinal (GI) related adverse events was observed with a profile for BIO89-100 that was similar to placebo. Low rates of diarrhea (9.5% vs. 11.1% for placebo) and nausea (4.8% vs. 11.1% for placebo) and importantly, no vomiting were reported in BIO89-100 treated patients. No hypersensitivity AEs, few mild injection site reaction events, no tremor and no adverse effects on heart rate or blood pressure were observed.