Aligos Therapeutics' ALG-055009 Trial Met Primary Goal In MASH; In Talks For Fund; Stock Drops

(RTTNews) - Aligos Therapeutics, Inc. (ALGS), a clinical stage biopharmaceutical company focused on liver and viral diseases, announced Thursday positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-ß) agonist, in metabolic-dysfunction associated steatohepatitis or MASH subjects.

These results indicate that ALG-055009 warrants further development. The company said it currently is in early discussions with potential partners and evaluating a variety of options to fund the continued development.

In pre-market activity on the Nasdaq, Aligos shares were losing around 9 percent to trade at $12.90.

The company said it plans to complete the activities required for a Phase 2b study by the middle of 2025 and are assessing potential Phase 2b clinical trial designs.

An ongoing inflammatory response to excess fat deposits in the liver is referred to as MASH. In the absence of changes in diet and exercise, the inflammation inherent in MASH persists and may result in progressive fibrosis of the liver, which may result in cirrhosis.

HERALD (NCT06342947) is a randomized, double-blind, placebo-controlled trial that enrolled 102 subjects with presumed MASH and stage 1-3 liver fibrosis. Subjects were randomized to receive one of four doses of ALG-055009 or placebo given orally once daily for 12 weeks.

The company noted that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by Magnetic Resonance Imaging Proton Density Fat Fraction or MRI-PDFF.

ALG-055009 demonstrated a favorable tolerability profile with no serious adverse events, or clinical hyper/hypothyroidism. The majority of treatment emergent adverse events were mild to moderate, with one discontinuation due to worsening insomnia in a subject with pre-existing insomnia.

Lawrence Blatt, Chairman, President, and Chief Executive Officer at Aligos Therapeutics, said, "When designing ALG-055009, our goal was to create a potential best-in-class THR-ß agonist through enhanced potency and a superior PK profile. Today's data demonstrates that these enhanced pharmacologic properties did indeed translate into robust improvements in liver fat reduction. In addition, ALG-055009 demonstrated a favorable tolerability profile, which is important given that MASH medications will likely be administered for prolonged periods of time."

The company plans to present additional results and analyses at a future scientific meeting later this year.

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