Benzinga | Oct 11, 2021 08:06AM EDT

Galmed Pharmaceuticals Announces Results Of Its Phase 2b ARREST Trial Of Aramchol Published In Nature Medicine

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the one-year results of the global Phase 2b randomized placebo-controlled ARREST Trial of Aramchol in patients with NASH have been published in Nature Medicine ( https://www.nature.com/articles/s41591-021-01495-3).

The ARREST Phase 2b study randomized 247 patients with NASH confirmed by liver biopsy. Patients were randomized 2:2:1 to receive Aramchol 400mg, 600mg or placebo once daily. The manuscript describes the complete data analyses including reduction in liver fat by imaging, improvements in liver histology and liver enzymes as well as the very good safety profile of Aramchol.

Aramchol is the most advanced down regulator of SCD 1 in clinical development. Aramchol, by targeting this single receptor, an important metabolic master switch, induces cascade of events that leads to two main changes: in hepatocytes, Aramchol elevates the fatty acids oxidation (or in other words -- fat burn) and influences AMPK, which results also in reducing glycemic parameters; and in hepatic stellate cells, Aramchol down regulates collagen production (i.e. fibrosis). Data from the ARREST Phase 2b study published in this paper demonstrate how the mechanism of action of Aramchol translates into clinical performance.

This published study, in addition to mechanistic studies demonstrated and published thus far, provided the rationale for the continued development of Aramchol for patients with NASH and fibrosis and a potential to further improved efficacy using higher drug exposure (>50% higher).

The ARMOR study - a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Aramchol 300mg twice daily in subjects with NASH with an open-label part to evaluate the safety, PK and treatment response kinetics of Aramchol is currently ongoing (NCT04104321).

Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Universit?, the paper's lead author and the ARMOR study co-principal investigator commented "The publication of the detailed results of the ARREST trial in a prestigious general medical journal such as Nature Medicine speaks to the interest of the scientific community towards this molecule with an innovative mode of action and its potential for treating fibrotic NASH. We look forward to seeing the impact of an optimized Aramchol exposure in NASH patients from the Phase 3 ARMOR trial"

"The publication of these data in Nature Medicine speaks to the strong interest from the clinical community in this unmet need area. We are grateful to all the patients and clinical sites that participated in the study around the world", said Allen Baharaff, President and Chief Executive Officer of Galmed. "Coupled with new recent publications elucidating Aramchol's MoA and particularly its direct effect on fibrosis, these results underscore the significant potential of Aramchol as a therapeutic option for patients diagnosed with NASH and Fibrosis. We are committed to evaluating the safety and efficacy of Aramchol in patients diagnosed with NASH and Fibrosis in our ongoing ARMOR Phase 3 study."