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Ionis Pharma’s fatty liver disease drug succeeds in mid-stage trial

Mar 14,2024

Ionis Pharmaceuticals said on Wednesday its experimental drug to treat a type of fatty liver disease met the main goal of reducing inflammation of the critical organ in a mid-stage trial.

The results come as companies race to bring the first approved treatment for the disease and tap into a global market expected to surpass $16 billion by 2030, according to market research firm Vision Research Reports.

Akero Therapeutics last week reported its experimental drug significantly reduced scarring after nearly two years in a mid-stage study while the U.S. Food and Drug Administration is expected to decide on Madrigal Pharmaceuticals ‘ treatment by Thursday.

The trial enrolled 160 metabolic dysfunction-associated steatohepatitis (MASH) patients with scarring or fibrosis at severity of stage two or three, Ionis said.

The company said 32 per cent of patients who received a higher dose of the drug, called ION224, saw improved scarring in the liver by at least one stage as measured by a biopsy, or tissue examination, compared to 12.5 per cent patients on placebo.

Ionis said 44 per cent of patients treated with a higher dose version achieved more than 50 per cent relative reduction in abnormal retention of fat when measured by a quantitative imaging biomarker compared to 3 per cent for placebo.

The company studied the drug – designed to reduce the production of an integral membrane protein – for 51 weeks in a two-part trial.

The condition, earlier called non-alcoholic steatohepatitis (NASH), affects around 5 per cent of the U.S. population.

Ionis said a subgroup analysis indicated significant improvements in the main trial goal in patients with advanced liver scarring.

The company’s shares were up 4 per cent before the bell on Wednesday.

Source: Pharma

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