Galmed Pharmaceuticals Ltd. (GLMD) said that the FDA agreed with its plan to use Aramchol meglumine in its Phase 3 ARMOR study without the need to conduct additional nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol meglumine.
In Monday pre-market trade, GLMD was trading at $2.70 up $0.21 or 8.43%.
Galmed considers the FDA's agreement a significant validation of Galmed's consistent efforts to maximize the potential of Aramchol in developing a nonalcoholic steatohepatitis or NASH treatment.
The company noted that the FDA supported its limited clinical pharmacology study plan with respect to Aramchol meglumine.
Aramchol meglumine is an improved compound using a salt form of Aramchol that has significantly greater water solubility than the free acid and an NCE patent protection valid until December 2034. Aramchol meglumine contains the same active pharmaceutical ingredient (API) called Aramchol.
The company noted that cinical pharmacology studies in healthy volunteers demonstrated that administration of Aramchol meglumine doubled the systemic exposure of Aramchol compared with that after dosing Aramchol free acid.
Exposure with once daily 383mg Aramchol meglumine oral dosage corresponds to that obtained with the existing twice daily 300mg Aramchol free acid form which is currently being evaluated in the Phase 3 ARMOR study.
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