Aeterna Zentaris Completes Final Patient Visit in Key DETECT-Trial for Diagnosing Childhood Growth Hormone Deficiency

Aeterna Zentaris Inc., a specialized biopharmaceutical company, announced the completion of its Phase 3 clinical trial, AEZS-130-P02, known as the DETECT-trial, evaluating macimorelin for diagnosing Childhood Onset Growth Hormone Deficiency (CGHD). This trial, aiming to assess the safety and efficacy of macimorelin, successfully concluded on June 13, 2024, with the final patient visit. The multicenter, open-label study involved 100 participants across Europe and North America, examining the impact of a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test (GHST) for pediatric patients suspected of having growth hormone deficiency (GHD). Aeterna Zentaris is set to report the top-line data from this trial in the third quarter of 2024.

The CEO of Aeterna Zentaris, Gilles Gagnon, highlighted the significance of the DETECT-trial's completion, noting it as a considerable milestone for the company. Gagnon emphasized that developing macimorelin as a diagnostic tool for children represents a substantial advancement, potentially broadening the market within endocrinology and offering notable benefits for patients. He expressed gratitude towards the patients, clinical staff, and shareholders for their cooperation and support throughout the study. The company looks forward to sharing the top-line data and comprehensive results in the upcoming months.

The DETECT-trial, being the final required study, aligns with the Pediatric Investigation Plan agreed upon with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This trial is a pivotal part of Aeterna's efforts to expand the diagnostic use of macimorelin, which is already approved for adult growth hormone deficiency (AGHD) diagnosis.

Macimorelin, marketed as GHRYVELIN™ in the European Economic Area and Macrilen® in various other regions, is an oral drug that stimulates growth hormone secretion from the pituitary gland. Approved by the FDA in 2017 and by the EMA in 2019, macimorelin's accuracy in diagnosing AGHD is comparable to the standard insulin tolerance test (ITT) but offers a safer profile and reduces false positives, thus preventing unnecessary treatments.

Aeterna Zentaris Inc. is dedicated to the development and commercialization of a diverse portfolio of pharmaceutical and diagnostic products. One of its leading products, macimorelin, is the only oral test approved by both the U.S. FDA and the European Commission for diagnosing AGHD. The company is also exploring therapeutic assets and proprietary extraction technology to produce active ingredients for cosmeceutical products and potential nutraceuticals or pharmaceuticals.

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