All subjects achieved sustained HBV RNA
Additionally, the late-breaker oral presentation highlighted the best-in-class potential of ALG-055009, a purpose built THR-β agonist discovered by Aligos scientists. 12-weeks of once daily ALG-055009 treatment in MASH patients met the primary endpoint, with robust reductions in liver fat content at Week 12. Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to 46.2% as measured by MRI-PDFF. Up to 70% of subjects achieved ‰¥30% relative reduction in liver fat compared to baseline, a positive prognostic indicator of histological improvements in MASH resolution and fibrosis reduction. Eighteen subjects who were on stable GLP-1 agonist therapy qualified for enrollment in the study, with liver fat content meeting the inclusion criteria of ‰¥10% at baseline as measured by MRI-PDFF. Notably, 11/14 subjects on stable GLP-1 agonists treated with ALG-055009 had liver fat decreases, whereas 4/4 subjects on stable GLP-1 agonists treated with placebo had increases in liver fat over the 12-week dosing period.
Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a) and apolipoprotein B and dose-dependent increases in SHBG were observed. In particular, ALG-055009 demonstrated a dose-dependent reduction from baseline of up to 26.8% at Week 12 for lipoprotein (a), which is an established risk factor for cardiovascular disease that has been resistant to treatment with statin therapy. Treatment with ALG-055009 was well-tolerated, with rates of gastrointestinal-related AEs similar to placebo.
The presentation of longer duration dosing of ALG-000184 in CHB patients strengthens our belief that this therapy will become both first-line for chronic suppression as well as the backbone of next generation HBV treatments aimed at functional cure, stated Lawrence Blatt, PhD, MBA, Chairman, President, & CEO of Aligos Therapeutics. Additionally, we are pleased to have presented the HERALD data, showing robust reductions in liver fat for patients treated with ALG-055009. The subgroup analysis in patients enrolled in the study on stable GLP-1 agonist therapy suggests a role for ALG-055009 to augment liver fat reductions in patients receiving incretin therapy.
Details of the presentations are as follows:
ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B (CHB)
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