Aeterna Zentaris’s ongoing DETECT trial is evaluating the drug macimorelin (tradename Macrilen™) for childhood-onset growth hormone deficiency (CGHD).
As recently announced in an article published by GlobeNewsWire, the study (AEZS-130-PO2), investigates the safety and efficacy of one oral dose (1.0 mg/kg) of macimorelin acetate. The test is a growth hormone stimulation test (GHST) for pediatric patients who are suspected of having a deficiency in growth hormones.
About CGHD
In CGHD, the pituitary gland does not produce sufficient growth hormone during childhood resulting in children with unusually short stature. The disorder may be present at birth (congenital) or acquired. Most often there is no clear, cause but there have been several genetic causes suggested. In older children, puberty is often delayed or nonexistent. Current treatments involve growth hormone injections.
About the Trial
Clinical trial sites are now open to recruiting patients in Europe and the United States. Children between the age of two and eighteen with possible deficiencies in growth hormones will be included. National trial approvals and initiation of site activities are ongoing in Europe.
A minimum of forty pre-pubertal and forty subjects in pubertal status will be included in the study. Expectations are that approximately one hundred subjects in North America and Europe will take part in the trial. The GHST of macimorelin is conducted twice to confirm the data’s repeatability.
The two GHSTs included in the trial as controls are Arginine and Clonidine.
COVID and Ukraine
COVID-19 continues to have an impact on patient enrollment and site activation for the trial. Planning for trial sites has been halted in Russia and Ukraine due to Russia’s invasion of Ukraine.
Both situations have caused significant delays in enrollment. Additional delays are expected. Principals in the DETECT trial had planned on a minimum of twenty-five percent enrollment in both Russia and Ukraine.
Analysis by Aeterna and Novo Nordisk on the effect of halting sites and enrollment led planners to estimate a continuance of the DETECT trial through 2023.
Aeterna CEO Klaus Paulini, M.D. said that Ukraine is foremost in their thoughts at such a difficult time. He explained further that the Aeterna team is expending every effort to complete the DETECT clinical trial as efficiently and as quickly as possible.
Dr. Paulini acknowledged that his company and its partner are working on alternate sites that will mitigate the impact on trial completion caused by Russia and Ukraine’s absence.
Additional information is available at EU Clinical Trials #2018-001988-23.
Aeterna Zentaris Biopharmaceutical
Aeterna Zentaris has a diversified pipeline of diagnostic and pharmaceutical products targeting areas of medicine with substantially unmet needs.
Aeterna’s lead product is macimorelin (Macrilen™). The product has the distinction of being the only oral test approved by the Food and Drug Administration and European Commission to diagnose hormone deficiency in adults.
