Galmed Pharmaceuticals initiated ARMOR, a phase III/IV registrational study of Aramchol in subjects With NASH and fibrosis.

Galmed Pharmaceuticals Ltd. announced the initiation of its Phase III/IV ARMOR clinical study to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis . This double-blind, placebo-controlled, global study will be conducted in approximately 185 sites in the U.S., Europe, Latin America and Asia.

The ARMOR study will evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes. A total of 2000 subjects will be randomized 2:1 to receive Aramchol 300mg BID or matching placebo. The study is designed to consist of two parts. In the first part (Histology-Based) 1200 subjects will be treated with Aramchol or matching placebo for 52 weeks. The Histology-Based data will serve as the basis for the submission of a marketing authorization application under regulatory provisions of accelerated/conditional approval. In the second part (clinically-based), all subjects will continue with the same treatment assignment until study completion to confirm clinical efficacy. The ARMOR study is designed based on the phase IIb results and FDA guidance and is powered to meet the two alternative key Histology-Based endpoints: (i) NASH resolution and no worsening of liver fibrosis, and (ii) fibrosis improvement without NASH worsening. Meeting one of these endpoints is expected to suffice for the study success of the first part. More information about the ARMOR Study may be found on ClinicalTrials.gov identifier: NCT04104321.

Prof. Arun Sanyal, Principal Investigator of the study commented, "Aramchol improves both the metabolic underpinning and lipotoxic stress driving NASH and fibrogenic drive by its effects on stellate cells. These pleiotropic beneficial effects along with the excellent safety and tolerability profile plus the positive data from earlier Phase IIA and IIB trials provide a strong rationale to proceed to a Phase III/IV trial. The possibility of developing a safe, well tolerated and effective treatment of active NASH with this molecule is exciting and I look forward to participating in this trial."

Galmed previously announced results from its Phase IIb ARREST study which were subsequently presented at AASLD 2018. Efficacy and safety data from this study included notable effects on key registrational endpoints of NASH resolution and fibrosis improvement and excellent safety supporting initiation of the Phase III/IV study. More recently, Galmed reported results from a study comparing once daily Aramchol 600 mg to twice daily 300 mg with a significant increase in exposure in the twice daily treatment arm and combined with the dose response pattern observed in prior Phase II studies, provides potential for additional efficacy with twice daily dosing.

About Aramchol and Non-alcoholic Steatohepatitis (NASH) : Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.