Dr. Klaus Paulini reports
AETERNA ZENTARIS PROVIDES UPDATE ON ONGOING PIVOTAL PHASE 3 Detect-TRIAL FOR THE DIAGNOSIS OF CHILDHOOD-ONSET GROWTH HORMONE DEFICIENCY
Aeterna Zentaris Inc. has provided an update for its continuing pivotal 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 Detect trial is a multicentre, open-label trial to investigate the efficacy and safety of a single oral dose of one milligram per kilogram macimorelin acetate as growth hormone stimulation test (GHST) in pediatric patients with suspected growth hormone deficiency (GHD).
The first clinical sites in the United States and in Europe are open for patient recruitment. In Europe, national clinical trial approval procedures and site initiation activities are continuing. Children and adolescents from two to less than 18 years of age with suspected growth hormone deficiency are to be included. The study is expected to include approximately 100 subjects in Europe and North America, with at least 40 subjects in prepubertal and 40 subjects in pubertal status. The macimorelin GHST will be performed twice for repeatability data and two standard GHSTs will be used as controls: arginine and clonidine.
Site activation and patient enrolment continues to be impacted by the continuing COVID-19 pandemic. Additionally, clinical trial sites originally planned in the Ukraine and Russia are being halted due to the conflict in Ukraine intensifying following the Russian invasion. As a result, further delays with enrolment are expected as the Detect trial planned to recruit at least 25 per cent (25 subjects) within those countries. Due to those circumstances, and after reviewing the resulting feasibility data from the company's contact research organization on potential mitigation options, Aeterna believes recruitment for the Detect trial may now continue until later into 2023. Aeterna and its development partner, Novo Nordisk, are actively assessing the full impact of the current situation on timelines and study cost.
"Our thoughts are with the patients, clinicians and all of the people of Ukraine during this difficult time. Our team is working to advance the Detect trial towards completion as quickly and efficiently as possible. Although our expected timeline is extended as a result of the delay caused by the pandemic and geopolitical events, we are working diligently in collaboration with our partner to consider alternate sites outside of the Ukraine and Russia to mitigate the potential impact of those events on estimated trial completion dates," commented,
Dr. Klaus Paulini, chief executive officer of Aeterna.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The company's lead product, macimorelin (Macrilen), is the first and only U.S. Food and Drug Administration and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need, in collaboration with Novo Nordisk.
Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing preclinical pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), Parkinson's disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Additionally, the company is developing an oral prophylactic bacterial vaccine against SARS-CoV-2 (COVID-19) and chlamydia trachomatis.
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