Most Read Articles
Pearl Toh, 3 days ago
Not only does the CGRP* inhibitor galcanezumab show sustained efficacy in migraine patients, long-term treatment does not come with excess cardiovascular (CV) risk, according to studies presented at the AAN 2021 Annual Meeting.
01 Apr 2021
Migraine and headache are common ailments of people living in the modern era. Dr Jon Marshall of The Singapore Headache and Migraine Clinic shares his insights with Pearl Toh on how to manage migraine and headache using non-pharmaceutical strategies, with a focus on the manual medicine approach.
Elvira Manzano, 3 days ago
An investigational transdermal amphetamine patch worn for 9 hours on the hip appeared effective in paediatric patients with attention deficit-hyperactivity disorder (ADHD) in a phase II, two-part trial.
Tristan Manalac, 4 days ago
Visceral fat area is the strongest indicator of mobility disability among obese, community-dwelling, older adults, according to a recent Singapore study.

BIO89-100 reduces liver fat in NASH

Elaine Soliven
27 Apr 2021

Weekly (QW) or biweekly (Q2W) treatment with BIO89-100 led to a significantly reduced liver fat and liver fat volume (LFV) in patients with nonalcoholic steatohepatitis (NASH), according to a recent study presented at ENDO 2021.

This phase 1b/2a, double-blind, placebo-controlled, multiple ascending-dose study analysed 81 patients diagnosed with biopsy-proven (n=15) or phenotypic NASH (n=66) who had a baseline liver fat of ≥10 percent, as measured by MRI-PDFF*. Subjects were randomized to receive BIO89-100 QW [3, 9, 18, or 27 mg] or Q2W dosing [18 or 36 mg] (n=62; mean age 51.7 years) or placebo (n=19; mean age 52.6 years) for a 12-week treatment period. [ENDO 2021, abstract P02-53]

At week 13, all BIO89-100 dosing groups experienced significant reductions in liver fat compared with the placebo group (placebo-adjusted relative change, from -46.0 to -70.0 percent [for QW doses] and from -53.0 to -60.0 percent [for Q2W doses]; p<0.001 for all doses), with the most pronounced effect observed in the 27 mg QW dosing group (-70.0 percent).

Majority of the patients treated with BIO89-100 also achieved a clinically meaningful responder rate of ≥30 percent (60.0–86.0 percent and 69.0–88.0 percent for QW and Q2W dosing groups, respectively) and responder rate of ≥50 percent (20.0–71.0 percent and 39.0–50.0 percent, respectively), whereas none was reported with placebo treatment.

BIO89-100 recipients also achieved a significant reduction in LFV at week 13 compared with the placebo recipients (from -36.0 to -65.0 percent [for QW doses] and from -46.0 to -56.0 percent [for Q2W doses] vs 12.0 percent; p<0.001 for all doses).

In a subgroup of patients with elevated ALT+ (>45.0 U/L) at baseline, those on BIO89-100 showed a greater reduction in ALT levels than those on placebo at week 13 (absolute change, -35.0 vs -10.3 U/L; p<0.05).

With regard to lipid profile, particularly those with high triglyceride levels (≥200 mg/dL) at baseline, the BIO89-100 arm demonstrated a decrease in triglyceride (33.0–49.0 percent) and non-HDL cholesterol levels (8.0–29.0 percent).

Fewer patients reported gastrointestinal-related adverse events (AEs), such as diarrhoea and nausea (9.5 percent and 4.8 percent, respectively, vs 11.1 percent), in the BIO89-100 arm vs the placebo arm.

Additionally, two serious AEs were reported, which were both COVID-19 infections, but were considered unrelated to study treatment.

“[Overall,] in subjects with NASH, [both] BIO89-100 [QW and Q2W dosing] led to robust, significant, and clinically meaningful reductions in liver fat and LFV assessed by MRI-PDFF, … with concurrent beneficial effects on lipids and other metabolic parameters,” said the researchers.

“The promising clinical profile of BIO89-100 supports further development in NASH and severe hypertriglyceridaemia,” they added.

 

*MRI-PDFF: Magnetic resonance imaging-proton density fat fraction
**
ALT: Alanine aminotransferase

Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Endocrinology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Pearl Toh, 3 days ago
Not only does the CGRP* inhibitor galcanezumab show sustained efficacy in migraine patients, long-term treatment does not come with excess cardiovascular (CV) risk, according to studies presented at the AAN 2021 Annual Meeting.
01 Apr 2021
Migraine and headache are common ailments of people living in the modern era. Dr Jon Marshall of The Singapore Headache and Migraine Clinic shares his insights with Pearl Toh on how to manage migraine and headache using non-pharmaceutical strategies, with a focus on the manual medicine approach.
Elvira Manzano, 3 days ago
An investigational transdermal amphetamine patch worn for 9 hours on the hip appeared effective in paediatric patients with attention deficit-hyperactivity disorder (ADHD) in a phase II, two-part trial.
Tristan Manalac, 4 days ago
Visceral fat area is the strongest indicator of mobility disability among obese, community-dwelling, older adults, according to a recent Singapore study.