Aligos Therapeutics has announced positive topline results from the Phase IIa HERALD clinical trial of ALG-055009, a thyroid hormone receptor beta agonist, for treating metabolic-dysfunction-associated steatohepatitis (MASH).
The double-blind, randomised, placebo-controlled study enrolled 102 subjects with presumed MASH and stage I-III liver fibrosis.
Subjects were assigned to receive one of four doses of ALG-055009 or placebo once a day for 12 weeks.
The primary endpoint focused on the relative variation in liver fat content at week 12.
Safety, pharmacokinetics (PK) and other non-invasive biomarkers/tests were also assessed in the trial.
According to the findings, doses ranging from 0.5mg to 0.9mg of ALG-055009 led to notable median relative reductions in liver fat, with up to 70% of subjects experiencing a ≥30% relative decrease from baseline.
The treatment also had a favourable tolerability profile, with no serious adverse events or signs of clinical hyper/hypothyroidism reported.
Most of the treatment-emergent adverse events in the trial were observed to be mild to moderate.
The incidence of gastrointestinal-related adverse events following ALG-055009 treatment was similar to the placebo group.
In addition to the reduction in liver fat, ALG-055009 treatment resulted in significant decreases in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B.
Aligos Therapeutics chairman, president and CEO Lawrence Blatt said: “The data demonstrates that these enhanced pharmacologic properties did indeed translate into robust improvements in liver fat reduction.
“We are currently in early discussions with potential partners and evaluating a variety of options to fund the continued development. We plan to complete the activities required for a Phase IIb study by the middle of 2025 and are assessing potential Phase IIb clinical trial designs.”
In March 2022, the company stopped dosing of subjects in the first chronic hepatitis B (CHB) group of the Phase I ALG-020572-401 trial of its antisense oligonucleotide drug candidate, ALG-020572.
