AEZS - Aeterna Zentaris commences late-stage growth hormone deficiency trial

Aeterna Zentaris (AEZS) announces the commencement of its pivotal Phase 3 safety and efficacy study AEZS-130-P02 evaluating macimorelin for the diagnosis of childhood-onset growth hormone deficiency (“CGHD”).The multicenter, open-label trial looks to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as growth hormone stimulation test (“GHST”) in pediatric patients suspected to be affected by the condition.The study is expected to enroll about 100 participants worldwide, with at least 40 participants in pre-pubertal and 40 participants in pubertal status.The company said that the Planned completion of the pivotal Phase 3 study is expected in Q3 2022.Shares up more than 4% premarket.

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Aeterna Zentaris commences late-stage growth hormone deficiency trial