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Phase IIb

ARamachol for REsolution of STeatohepatitis (ARREST)

A Phase IIb, double blind randomized, controlled clinical trial, to evaluate the efficacy and safety of two Aramchol™ doses versus placebo in patients with Non-​Alcoholic Steatohepatitis (NASH)

Study Arms

400mg; 600mg; Placebo (2:2:1)

Treatment Plane

Once-​daily tablet for 12 months and 3 months follow-​up

Primary Endpoint

Percent change in the liver triglyc­erides concen­tration measured by MRS

No. of Subjects

N=247

Secondary Endpoint

Proportion in percentages of subjects with CRN Fribrosis Score Improvement without worsening of NASH

Proportion in percentages of subjects with NAS score improvement — less than two points — without worsening of CRN Fibrosis Score

Proportion in percentages of subjects with NASH Resolution — ballooning 0; inflam­mation 0 or 1 — without worsening of CRN Fibrosis Score

More infor­mation about the ARREST study may be found on ClinicalTrials​.gov (identifier: NCT02279524); this study has been completed

Global Distribution and Baseline Histology of Randomized Patients

The ARREST study is being conducted in 80 centers in 12 countries. Approximately 1/​3 of the patients are from the USA, 1/​3 from Europe and 1/​3 from RoW.

Four Continents, 12 Countries, 80 Centers

ARREST enrolled a population with advanced NASH with fibrosis enabling the design of the pivotal Phase III study with a single dose and optimized primary endpoint. Patients enrolled into the ARREST study showed advanced disease, 60% having stage 2 and 3 fibrosis at baseline and 70% with NAS>5.

Pie chart One: 70 percent of patients have NAS greater than 5. Pie chart Two: 60 percent of patients have fibrosis stage 2 and 3.
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