TORONTO - Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), a specialty biopharmaceutical company, announced today the clinical completion of its Phase 3 study, known as the DETECT-trial, evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency (CGHD). The last patient visit was completed successfully in Europe on June 13, 2024.
The DETECT-trial, which is a multicenter, open-label study, aimed to assess the safety and efficacy of a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test in pediatric patients with suspected growth hormone deficiency. The trial enrolled 100 subjects across Europe and North America.
Gilles Gagnon, CEO of Aeterna Zentaris, stated that the trial's completion is a significant achievement for the company. He expressed his gratitude towards the patients, clinical staff, and shareholders for their contributions and support. Gagnon also shared the company's anticipation for the upcoming presentation of top-line data and full study results expected in the third quarter of 2024.
Macimorelin is an orally administered peptidomimetic molecule that stimulates the secretion of growth hormone, which is measured in blood samples post-administration for the assessment of growth hormone deficiency. It has been approved for use in adults in the United States, South Korea, Israel, and the European Economic Area under the names Macrilen and GHRYVELIN.
The DETECT-trial is the second and final study required for evaluating the potential use of macimorelin as a diagnostic test in children, following agreements with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the company's Pediatric Investigation Plan.
Aeterna Zentaris specializes in developing and commercializing pharmaceutical and diagnostic products, with a focus on addressing unmet medical needs. Macimorelin is one of the company's lead products, and it is the only oral test approved by the U.S. FDA and European Commission for the diagnosis of adult growth hormone deficiency.
The information reported here is based on a press release statement.
In other recent news, Aeterna Zentaris and Ceapro have finalized their all-stock merger, creating a combined entity with a diversified portfolio. The merger is expected to enhance the company's revenue base and development programs. The new entity anticipates a stable cash flow to support the research and development of high-return pharmaceutical products.
Aeterna Zentaris also announced a reverse stock split, reducing the number of issued and outstanding common shares from approximately 4.86 million to about 1.21 million. The consolidation was a strategic step in the merger process with Ceapro. In addition, Aeterna Zentaris and Ceapro received a final court order to proceed with their merger, which was expected to be finalized in the second quarter of 2024.
InvestingPro Insights
As Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) reaches a pivotal moment with the completion of its Phase 3 DETECT-trial for macimorelin, the financial metrics and analyst outlooks provide a broader picture of the company's position. With a market capitalization of just $5.06 million, Aeterna Zentaris is a relatively small player in the biopharmaceutical field. Despite a gross profit margin of an impressive 90.69% for the last twelve months as of Q1 2024, the company's revenue has seen a steep decline of 62.02% during the same period.
InvestingPro Tips indicate that while Aeterna Zentaris holds more cash than debt on its balance sheet, it is quickly burning through cash, which is reflected in the substantial operating income loss of $19.91 million. The company's stock price has been volatile and has experienced significant declines over various time frames, including a 40.62% drop over the past year. However, analysts predict the company will be profitable this year, which could signal a turning point for the firm.
Investors interested in the detailed analysis and additional insights can explore more InvestingPro Tips for Aeterna Zentaris, which include further discussion on valuation, stock performance, and profitability forecasts. There are 12 additional InvestingPro Tips available at: https://www.investing.com/pro/AEZS. For those considering a deeper dive into the company's financials and future prospects, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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