Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency

Core Insights - Aeterna Zentaris Inc. has completed its Phase 3 safety and efficacy study (DETECT-trial) for macimorelin, aimed at diagnosing Childhood Onset Growth Hormone Deficiency (CGHD) [1][2][3] - The company plans to report top-line data and complete study results in Q3 2024 [1][2] Company Overview - Aeterna Zentaris is a specialty biopharmaceutical company focused on developing and commercializing a diverse portfolio of pharmaceutical and diagnostic products [7] - One of its lead products, macimorelin, is the first and only FDA and European Commission approved oral test for diagnosing adult growth hormone deficiency (AGHD) [7] Study Details - The DETECT-trial is a multicenter, open-label trial that enrolled 100 subjects in Europe and North America, testing a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test [2][3] - This trial is the second and final study required for evaluating macimorelin's use as a diagnostic test in children, as per agreements with the FDA and EMA [3] Product Information - Macimorelin (Macrilen®; GHRYVELIN™) is an oral drug that stimulates growth hormone secretion from the pituitary gland and is used for diagnosing AGHD [5][6] - The drug was approved by the FDA in 2017 and by the EMEA in 2019, demonstrating accuracy comparable to standard insulin tolerance testing but with a better safety profile [6]