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First patient enrolled in Aeterna Zentaris' late-stage Macrilen confirmatory study

  • Patient enrollment is underway in Aeterna Zentaris' (AEZS -3.3%) confirmatory Phase 3 clinical trial assessing Macrilen (macimorelin) in adult growth hormone deficiency (AGHD). The two-way crossover study will use the insulin intolerance test (ITT) as the benchmark comparator and will recruit at least 55 ITT-positive and 55 ITT-negative subjects with medical histories documenting risk factors for AGHD.
  • The primary endpoint is the validation of a single oral dose of macimorelin for the diagnosis of AGHD as measured by the percent positive and negative agreement with ITT. According to clinicaltrials.gov, the estimated study completion date is October 2016. The study is being conducted to address the issues cited in the FDA's CRL that the company received in November 2014.
  • Orphan Drug-tagged Macrilen is a ghrelin ("hunger hormone") agonist that stimulates the secretion of growth hormone.
  • Previously: Aeterna Zentaris to conduct new Phase 3 study to demonstrate efficacy of Macrilen (April 13)
  • Previously: Aeterna Zentaris slammed after FDA rejection (Nov. 6, 2014)

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