Aramchol has been shown to down-regulate the expre

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Aramchol has been shown to down-regulate the expression and activity of stearoyl-CoA desaturase-1 (SCD1) in hepatic stellate cells, resulting in a direct effect on fibrogenesis.

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When it comes to Israel biopharmaceutical companies I look much closer at their claims. The Israel version of the FDA and SEC seem to be totally lax in their oversight.

There may be some improvement but the methodology is a bit suspect and isn't comparative to a previous study.

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Treatment with Aramchol 300mg BID resulted in a high rate of subjects with fibrosis improvement using NASH CRN, paired ranked reading and Artificial Intelligence (AI) quantitative digital analysis.

- At week 48, both paired and AI evaluations identified more subjects with fibrosis improvement (65% and 100% respectively) compared to NASH CRN scoring.
https://galmedpharma.investorroom.com/2022-04...assessment

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NASH CRN is a composite of all symptomology not just fibrosis. The paired reading is subject to bias. Using AI is simply laughable. It's an open label part of the trial not blinded.

What I find suspect is that this trial has not been submitted to the FDA and is not listed on clinicaltrials.gov. With the U.S. being the most lucrative drug market the main reason you wouldn't submit is you don't want the oversight.

So let's look at Galmed's previous phase 2b trial that was blinded.

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The primary end point was a decrease in hepatic triglycerides by magnetic resonance spectroscopy at 52 weeks with a dose of 600 mg of Aramchol. Key secondary end points included liver histology and alanine aminotransferase (ALT). Aramchol 600 mg produced a placebo-corrected decrease in liver triglycerides without meeting the prespecified significance (-3.1, 95% confidence interval (CI) -6.4 to 0.2, P = 0.066), precluding further formal statistical analysis. NASH resolution without worsening fibrosis was achieved in 16.7% (13 out of 78) of Aramchol 600 mg versus 5% (2 out of 40) of the placebo arm (odds ratio (OR) = 4.74, 95% CI = 0.99 to 22.7) and fibrosis improvement by ≥1 stage without worsening NASH in 29.5% versus 17.5% (OR = 1.88, 95% CI = 0.7 to 5.0), respectively. The placebo-corrected decrease in ALT for 600 mg was -29.1 IU l-1 (95% CI = -41.6 to -16.5).
https://pubmed.ncbi.nlm.nih.gov/34621052/

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Didn't meet primary endpoint. 11.7 % of patients had no worsening of fibrosis and 12% of patients had an improvement in fibrosis. Quite a difference compared to 65% and 100%.