Aeterna Zentaris Says Enrollment In Growth Hormone Deficiency Trial To Continue Into 2023
Aeterna Zentaris Inc (NASDAQ: 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 (NYSE: 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.
See more from Benzinga
Twist Bioscience Launches Synthetic RNA Positive Controls For SARS-CoV-2 Encapsulated Minicapsules
KemPharm's SDX Higher Dose Shows Potential Against Sleep Disorders
Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.