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GALMED PHARMACEUTICALS LTD.

(GLMD)
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Galmed Pharmaceuticals Ltd. Announces One-Year Results of Global Phase 2b Randomized Placebo-Controlled ARREST Trial of Aramchol in Patients with Non-Alcoholic Steatohepatitis

10/11/2021 | 08:00am EST

Galmed Pharmaceuticals Ltd. announced that the one-year results of the global phase 2b randomized placebo-controlled ARREST Trial of Aramchol in patients with Non-alcoholic Steatohepatitis (NASH) have been published in Nature Medicine. 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 (that is 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% high). 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).


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Financials (USD)
Sales 2021 - - -
Net income 2021 -33,6 M - -
Net Debt 2021 - - -
P/E ratio 2021 -1,84x
Yield 2021 -
Capitalization 60,7 M 60,7 M -
Capi. / Sales 2021 -
Capi. / Sales 2022 -
Nbr of Employees 21
Free-Float 86,0%
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Number of Analysts 5
Last Close Price 2,42 $
Average target price 17,60 $
Spread / Average Target 627%
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Managers and Directors
Allen Baharaff Chairman, President & Chief Executive Officer
Yohai Stenzler Chief Financial Officer
Liat Hayardeny Chief Scientific Officer
Guy Nehemya Chief Operating Officer
Shmuel Nir Independent Director
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