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Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency

Provided By GlobeNewswire

Last update: Jun 13, 2024

Company expects to report top-line data and complete study results in Q3 2024

TORONTO, ONTARIO, June 13, 2024 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products and active ingredients for healthcare and cosmetics industries, today announced the clinical completion of its Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency ("CGHD").

The Company confirms that the last patient conducted the last study visit successfully in Europe on June 13, 2024. The DETECT-trial is a multicenter, open-label trial 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 with suspected growth hormone deficiency ("GHD"). The study enrolled 100 subjects in Europe and North America. The Company remains on track to report top-line data for the DETECT-trial in Q3 2024.

Gilles Gagnon, Chief Executive Officer of the Company commented, “The completion of the DETECT-trial represents a major milestone for the Company. In addition to the already approved indication for adults, the successful development of macimorelin as a unique diagnostic tool for the detection of growth hormone deficiency in children would represent a major benefit for patients while significantly expanding this market in endocrinology. On behalf of the Company, I would like to thank the patients and clinical staff for their continued efforts to bring this study across the finish line as well as our shareholders for their continued support. Looking ahead, we are eagerly anticipating the presentation of the top-line data as well as the full study results in the third quarter of this year.”

Read more at globenewswire.com
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