89bio reports positive data from Phase 1 clinical trial of BIO89-100
Category: #health  By Mateen Dalal  Date: 2019-05-24
  • share
  • Twitter
  • Facebook
  • LinkedIn

89bio reports positive data from Phase 1 clinical trial of BIO89-100

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

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

MoA Technology targets herbicide resistance crisis & raises $8 million
MoA Technology targets herbicide resistance crisis & raises $8 million
By Mateen Dalal

MoA Technology has created three platforms: MoA SELECTTM, MoA TARGETTM and MoA GALAXYTM, which would work together for effective herbicide creation.   MoA Technology is borne out of Oxford University research is aimed at inhibiting herbicide...

Trump refuses to forge deals with Huawei citing national security
Trump refuses to forge deals with Huawei citing national security
By Mateen Dalal

Donald Trump declares the business with Huawei as a national threat and hence forth has declined all the business opportunities with the company.   The existing contract of the Commerce Department is expected to end sooner. The United Stat...

Trovagene to unveil key study data at APAC Prostate Cancer Conference
Trovagene to unveil key study data at APAC Prostate Cancer Conference
By Mateen Dalal

Data from the Phase 2 Onvansertib clinical trial will be presented at the 20th Prostate Cancer Conference.   The trial assesses the efficacies of Onvansertib on patients with Metastatic Castration-Resistant Prostate Cancer. Trovagene, a cl...