- Aeterna Zentaris Inc AEZS has commenced its pivotal Phase 3 DETECT trial evaluating macimorelin as a diagnosis of childhood-onset growth hormone deficiency (CGHD).
- The investigational new drug application multicenter, open-label trial will investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test (GHST) in pediatric patients with suspected GHD.
- The macimorelin test will be compared to clonidine and an arginine test. Both are known standard stimulation tests.
- The study is expected to enroll approximately 100 participants.
- Patient enrollment on track to start this quarter, with trial completion expected in Q3 2022.
- Under new terms and conditions of the license agreement revised in November 2020, Aeterna will coordinate the activities related to the development of macimorelin in CGHD through a joint steering committee with Novo Nordisk A/S NVO.
- Price Action: AEZS shares are trading 2.91% higher at $0.91 during the premarket session on the last check Thursday.
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