Aligos claims mid-stage win in MASH, but investors are skeptical
Aligos claims mid-stage win in MASH, but investors are skeptical
Aligos Therapeutics on Thursday posted topline data from the Phase IIa HERALD study in metabolic dysfunction-associated steatohepatitis, showing that its drug candidate ALG-055009 significantly reduced liver fat.
At 12 weeks, patients who were treated with 0.5-mg, 0.7-mg and 0.9-mg doses of ALG-055009 had significantly lower liver fat, with median placebo-adjusted relative reductions of 24.1%, 46.2% and 43.6%, respectively. The lowest dose group, treated with 0.3-mg ALG-055009, saw a 19.7% decrease in liver fat, which failed to reach statistical significance.
In addition, up to 70% of participants achieved at least 30% relative reduction in liver fat from baseline, according to Aligos.
CEO Lawrence Blatt in a statement said that these findings highlight ALG-055009’s “enhanced pharmacologic properties,” which translated “into robust improvements in lifer fat reduction.” The drug candidate was also well-tolerated in HERALD, with no serious adverse events or episodes of clinical hyper- or hypothyroidism. Most treatment-emergent toxicities were mild to moderate.
Blatt made the case that ALG-055009’s favorable safety profile is “important” especially since treatments for metabolic dysfunction-associated steatohepatitis “will likely be administered for prolonged periods of time.”
With these data from HERALD, Aligos contends that ALG-055009 “warrants further development” and the company is holding “early discussions” with potential partners and is exploring other options to fund the candidate’s development, Blatt said. Aligos expects to complete required activities for a Phase IIb study by mid-2025.
Reuters
