Galmed Pharmaceuticals Provides Business Update and Reports First Quarter 2020 Financial Results

About this update from Galmed Pharmaceuticals Ltd.

[{"type":"text","content":"- Conference Call and Webcast Today at 8:30 a.m. ET / 5:30 a.m. PT -\n\n\nTEL AVIV, Israel, May 14, 2020 /PRNewswire/ --Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (\"Galmed\" or the \"Company\"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, provides today updated information on the Company's clinical development program and reports financial results for the three months ended March 31, 2020. The Company will host a conference call and webcast at 08:30 ET today.\n\n \n \n \n \n \n \n\n \nGalmed announces significant progress in the development of Aramchol meglumine, a salt version of Aramchol which has higher solubility, the same ADME profile, and is expected to have less variability in human plasma. Aramchol meglumine is considered a New Chemical Entity. As such, it is eligible for NCE patent protection until December 2034. Patents have been granted and maintained in 37 European territories, in Japan, Australia, China and Canada. Discussions on the patent protection in the USA with the USPTO are ongoing.\nResults from a single and multiple oral administration doses of Aramchol free acid and Aramchol meglumine in a cross over PK study in dogs, demonstrated bioequivalence with reduced variability. In particular: \nafter single dose administration, the AUCs Aramchol free acid and Aramchol meglumine are almost identical; after multiple dosing (steady state) AUC for the Aramchol meglumine was higher compared to Aramchol free acid; a three-fold reduction in coefficient variation in steady state in the Aramchol meglumine arm compared to Aramchol free acid suggesting lower variability among patients receiving Aramchol meglumine in the future; half-life of Aramchol while administration of both Aramchol free acid and Aramchol meglumine is identical in single and multiple dosing (steady state); and Cmax was higher in Aramchol meglumine compared to Aramchol free acid in steady state. Galmed plans to submit these results along with other supportive data to the FDA and discuss with the FDA, as soon as practical, a plan to appropriately transition from Aramchol free acid to the Aramchol meglumine in the ongoing ARMOR Phase 3 study. Based on Galmed's regulatory and scientific review of...

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