Aramchol resolves NASH without worsening of fibrosis in phase 2b study

Galmed Pharmaceuticals announced topline results from a phase 2b study of Aramchol, a once-daily liver-targeted stearoyl-Coenzyme A desaturase 1 modulator designed for the treatment of nonalcoholic steatohepatitis, according to a press release.

“Some studies [of Aramchol] have shown an effect on NASH and some on fibrosis, while this study has shown an effect on both,” Vlad Ratziu, MD, principal investigator of the ARREST study and professor of hepatology at the Sorbonne Université and Hospital Pitié in France, said. “NASH is a chronic disease with complex comorbidities and Aramchol’s favorable safety and tolerability profile support long-term treatment.”

Among 247 patients with biopsy-proven NASH who were overweight or obese, results of magnetic resonance spectroscopy at 52 weeks showed that patients treated with 400 mg of Aramchol (arachidyl amido cholanoic acid) had a significant reduction of liver fat (P = .045) compared with placebo and those treated with 600 mg had a significant reduction of 5% absolute change from baseline (P = .0279) compared with placebo.

Additionally, patients treated with 600 mg of arachidyl amido cholanoic acid were significantly more likely to achieve NASH resolution (19.2% vs. 7.5%; P = .0462) and NASH resolution without worsening of fibrosis (16.7% vs. 5%; P = .0514) compared with placebo; and a higher proportion of the 600-mg arm showed at least one-point improvement in fibrosis score without worsening of NASH (29.5% vs. 17.5%; P = .2110).

The researchers also observed significant reductions in alanine aminotransferase (P .0002) and aspartate aminotransferase levels (P .001) regardless of dose and two or more points of improvement in nonalcoholic fatty liver disease activity score and steatosis, activity and fibrosis score (P < .05).

At 52 weeks, the researchers observed serious adverse events in 12.5% of patients in the placebo arm, 8.9% in the 400-mg arm, and 9.2% in the 600-mg arm.

“Data from my laboratory submitted to an upcoming conference confirm by transcriptomic analysis a broad anti-fibrotic effect of Aramchol in fibrogenic hepatic stellate cells, which is complementary to the data seen in this phase 2b, biopsy-based clinical study,” Scott Friedman, MD, from the Icahn School of Medicine at Mount Sinai in New York, said in the release. “In my view, these results, together with its safety and tolerability, place Aramchol among the leading frontline therapeutic candidates under investigation for NASH.” – by Talitha Bennett

Reference: www.galmedpharma.com