A clinical-stage biopharmaceutical company, 89bio LTD that focusses on NASH (nonalcoholic steatohepatitis), liver and other metabolic disorders, recently announced positive results from Phase 1 SAD (single ascending dose) study on healthy volunteers of its investigational medicine, BIO89-100. The investigational medicine (BIO89-100) is a long acting glycopegylated FGF21 (fibroblast growth factor 21) analogue for treatment of patients with nonalcoholic steatohepatitis, reports source.

Hank Mansbach, Managing Director & Chief Medical Officer, 89bio said that there were consistent results from preclinical studies of BIO89-100 in its first in-human trial. In the study, the investigational medicine confirmed a favorable safety and a biomarker profile with an enduring response with a single dose. It has been expected that these findings will support weekly and 2-week subcutaneous dosing.

The medicine had robust pharmacodynamic effects across multiple lipid parameters, provided the subjects were healthy volunteers with lipid parameters in the normal range, Mansbach added.

Reportedly, BIO89-100 was mostly safe and well tolerated according to its Phase 1 study. The commonly observed adverse events were headache and injection-site reactions, which were mild. The PK (pharmacokinetic) profile of the medicine was generally a dose proportional with a half-life ranging from 53-100 hours, approximately. At single doses of 9.1 mg or higher, the medicine shows significant improvements as compared to baseline in key lipid parameters, measured at 8 & 15 days. The mean changes in comparison to baseline include decline in triglycerides up to 51% and LDL-C up to 37% along with increase in HDL-C up to 36%.

Rohan Palekar, Chief Executive Officer, 89bio, was reportedly quoted saying that the data from the experiment support the advancement of BIO89-100 in study of patients with liver disease, to assess its potential to address the complex nature of nonalcoholic steatohepatitis.

As per sources close to the matter, the first in-human trial of Bio89-100 was double-blind, single ascending dose study designed, randomized & placebo-controlled to evaluate safety, PK profile, tolerability & immunogenicity. It was tested on 58 healthy adult volunteers.

Source credits: https://www.prnewswire.com/news-releases/89bio-reports-positive-top-line-data-from-phase-1-single-ascending-dose-clinical-trial-of-bio89-100-an-investigational-medicine-for-nash-300854790.html