Aeterna Zentaris Inc AEZS provided an update for its ongoing pivotal Phase 3 study AEZS-130-P02 (the DETECT-trial) of macimorelin to diagnose childhood-onset growth hormone deficiency (CGHD).
- The DETECT trial investigates 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 growth hormone deficiency (GHD).
- The study will include approximately 100 subjects in Europe and North America.
- The Company says that the site activation and patient enrollment continue to be impacted by the ongoing COVID-19 pandemic.
- Additionally, trial sites planned initially in the Ukraine and Russia are being halted due to the conflict between the countries.
- As a result, further delays with enrollment are expected as the DETECT trial planned to recruit at least 25% (25 subjects) within those countries.
- Aeterna believes recruitment for the DETECT trial may continue until later into 2023.
- Aeterna and its development partner, Novo Nordisk A/S NVO, are actively assessing the full impact of the current situation on timelines and study costs.
- Price Action: AEZS shares are down 0.59% at $0.35 during the market session on the last check Monday.
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