Aeterna Zentaris announced favorable results of its Phase 3 study with AEZS-130 as the first oral diagnostic test for adult growth hormone deficiency (AGHD). AEZS-130, formerly ARD-07, was previously studied by Ardana Biosciences but was discontinued before completion for financial reasons. A Special Protocol Assessment granted by the FDA modified the original study so the completed portion of the previous study and the new part of the study would provide one, complete Phase 3 study. AEZS-130 has reached the primary endpoint of demonstrating >90% AUC (area-under-the-curve) of the Receiver Operating Characteristic curve, which determines the level of specificity and sensitivity of the product. In addition, 8 of the 10 newly enrolled AGHD patients were correctly classified by a pre-specified peak growth hormone threshold level.
AEZS-130 is an orally active, ghrelin agonist that stimulates the secretion of growth hormone.
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