89bio, Inc. Provides Corporate Update, Including its Roadmap for Advancing BIO89-100 in 2021
January 05, 2021 at 01:00 pm
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89bio, Inc. provided a corporate update, including its roadmap for advancing BIO89-100 in 2021. Key 2021 Milestones: Report topline data from the paired-biopsy, open-label histology cohort as part of the Phase 1b/2a trial of BIO89-100 in NASH by year-end 2021; Initiate the Phase 2b NASH trial as part of a potential Phase 2b/3 program in the first half of 2021; and Report topline data from the Phase 2 trial of BIO89-100 in SHTG in the second half of 2021. 89bio plans to initiate a Phase 2b NASH trial as part of a potential Phase 2b/3 trial in the first half of 2021. Additionally, the Company recently initiated a paired-biopsy, open-label histology cohort as part of the Phase 1b/2a trial of BIO89-100 in NASH, with data anticipated by the end of 2021. This cohort will enroll approximately 20 patients with biopsy-confirmed NASH and will provide an early opportunity to demonstrate BIO89-100’s benefits on histology endpoints. These patients will be treated for 20 weeks with 27 mg of BIO89-100 once weekly. The cohort will build on the recent data from 89bio’s Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial. The 13-week trial enrolled a total of 81 patients and demonstrated relative reductions in liver fat of up to 70% versus placebo, as measured by magnetic resonance imaging "proton density fat fraction (MRI-PDFF). A majority of patients achieved a = 30% (up to 88%) or a = 50% (up to 71%) reduction in liver fat. ALT was significantly reduced (up to 44%) in these patients and key lipid markers like triglycerides, LDL, and non-HDL were also significantly improved. Results were consistent across the sub-populations of biopsy-confirmed NASH and phenotypic NASH (PNASH) patients enrolled in the trial and baseline characteristics were similar across these sub-populations as were the reductions in liver fat. The percentage of responders on MRI-PDFF and BIO89-100’s effect on reducing ALT and triglycerides were also similar across these sub-populations. Overall, BIO89-100 had a favorable safety and tolerability profile with rates of gastrointestinal side effects such as nausea, diarrhea and vomiting similar to placebo. The ongoing Phase 2 trial investigating BIO89-100 for the treatment of severe hypertriglyceridemia (SHTG) will enroll approximately 90 patients. In this Phase 2 multi-center, randomized, double-blind, placebo-controlled study designed to evaluate safety, efficacy, and tolerability, BIO89-100 or placebo will be administered in one
of four treatment groups either weekly or every two weeks. The primary endpoint is the reduction in fasting triglycerides from baseline. Key secondary endpoints include the effect of BIO89-100 on other lipids and metabolic markers and change in liver fat measured by MRI-PDFF. Topline data from the study are expected in the
second half of 2021.
89bio, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies for the treatment of liver and cardio-metabolic diseases. The Companyâs lead product candidate, pegozafermin, a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21), is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and for the treatment of severe hypertriglyceridemia (SHTG). Pegozafermin is engineered to protect against proteolysis and reduce renal clearance and optimize its potency, enabling the potential use of a lower dosage/dose. Pegozafermin has been optimally constructed with two mutations via substitutions with natural amino acids at site-specific positions (173 and 176) toward the C-terminus end of the hormone. It conducted a Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics (PK) of pegozafermin.