89Bio launched a proof of concept phase 1b/2a clinical trial of BIO89-100 for the treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis with the first patient screened, according to a press release.
“We are pleased to advance our clinical development program for BIO89-100 with the initiation of this proof of concept trial following closely on our positive phase 1a data announced in May,” Hank Mansbach, MD, chief medical officer of 89bio, said in the release. "We believe that BIO89-100 has the potential to become a mainstay of NASH therapy by addressing both liver pathologies and the underlying metabolic dysregulation that results in NASH progression. BIO89-100 may also be well suited for extended interval dosing in patients, which could be a convenient option for patients in the treatment of a chronic condition."
The proof of concept trial will evaluate safety, tolerability and pharmacokinetic properties of BIO89-100, a glycopegylated analog of fibroblast growth factor 21, along with imaging and biomarker measurements.
Additionally, the randomized control trial will use multiple ascending dose-ranging cohorts in 83 patients with established NAFLD, established NASH, and those with a high risk for NASH for up to 12 weeks.