89bio announced positive top-line results from a phase 1 study of BIO89-100, a novel long-acting glycopegylated fibroblast growth factor 21 analogue under investigation for the treatment of nonalcoholic steatohepatitis, according to a press release.
“BIO89-100 demonstrated a favorable safety and biomarker profile with a durable response after a single dose,” Hank Mansbach, MD, chief medical officer of 89Bio, said in the release. “We believe these findings support both weekly and every 2-week subcutaneous (SC) dosing. Even more encouraging are the robust pharmacodynamic effects demonstrated across multiple lipid parameters, given the subjects were healthy volunteers with most mean lipid parameters in the normal range at baseline.”
The single-ascending dose randomized control study comprised 58 healthy adult volunteers. BIO89-100 was generally safe and well-tolerated. The most common treatment-related adverse events included mild injection site reactions and mild headaches.
Single dose treatment demonstrated significant improvements compared with baseline in key lipid parameters measured at 8 days and 15 days. Mean changes included reductions in triglycerides (up to 51%) and LDL cholesterol (up to 37%) and increases in HDL cholesterol (up to 36%).
“These data support the advancement of BIO89-100 into a study in patients with liver disease to evaluate its potential to address the complex nature of NASH, especially in patients with metabolic comorbidities,” Rohan Palekar, CEO of 89Bio, said in the release.