Date: 2016-06-06
Type of
information: update on patient enrollment
phase: 2b
Announcement: update
Company: Galmed Pharmaceuticals (Israel)
Product: aramchol
Action
mechanism: bile-acid conjugate. Aramchol is a conjugate of cholic acid and arachidic acid. This is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters. Aramchol affects liver fat metabolism and has been shown in a phase IIa clinical study to significantly reduce liver fat content as well as improve metabolic parameters associated with fatty liver disease.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic
area: Hepatic diseases - Liver diseases
Country: China, Israel, USA
Trial
details: ARREST Study is a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol. The trial's primary end-point is a statistically significant reduction of liver fat content measured by Magnetic Resonance Spectroscopy, or MRS, and the trial's secondary end-point is the complete resolution of NASH, as measured by two biopsies (at the beginning and at the end of the ARREST Study), and improvement of the NAFLD Activity Score (NAS), as well as an improvement in the markers of liver inflammation and various metabolic biomarkers.
Latest
news:
- • On June 7, 2016, Galmed Pharmaceuticals announced that it has expanded the clinical operations of its ongoing Phase IIb ARREST study into China. The trial investigator in China is Professor George K.K. Lau, who serves as Co-Director of Hepatology at 302 Hospital in Beijing and Director at Humanity and Health Medical Center in Hong Kong. Professor
- In parallel, Galmed has also initiated a pharmacokinetic study in Chinese subjects who are domiciled in the United States, entitled "Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered under Fed Conditions in Healthy Chinese Volunteers." The company expects to enroll up to 64 subjects in this six-month study, consisting of two parts. In part A, 32 subjects shall receive a single escalating dose; Part B shall enroll 32 subjects which shall receive a multiple escalating dose. Dr. Evelyn Darius will serve as the Study Investigator. If the PK profile from Part A is similar to the existing PK data in non-Chinese subjects, then the study may be stopped prior to enrolling Part B. The results of Part A of the PK study are expected to be available in August 2016.
- • On June 1, 2016, Galmed Pharmaceuticals announced that it had randomized half of the patients (N=120) in the ARREST Study. The company expects to reach full recruitement during the fourth quarter, 2016.
- • On November 9, 2015, Galmed Pharmaceuticals announced the commencement of patient screening for the ARREST Study in Europe.
- • On August 13, 2015, Galmed Pharmaceuticals announced that it has commenced patient screening for the ARREST Study in the United States and Latin America.
- • On March 9, 2015, Galmed Pharmaceuticals announced the beginning of enrollment in its Phase IIb clinical trial, or our ARREST Study, of aramchol in patients with non-alcoholic steato-hepatitis, who also suffer from obesity and insulin resistance. The triak is expected to take place in more than 70 centers in 12 countries, including the United States. In addition, Galmed announced that it has also expanded its clinical activities to include patient recruitment for the ARREST Study in the United States. Galmed expects to release top-line data by the end of 2016.
Is
general: Yes
