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Aeterna Zentaris Starts Research Study On How Well Macimorelin Works For Growth Hormone Deficiency Diagnosis


Benzinga | May 13, 2021 09:33AM EDT

Aeterna Zentaris Starts Research Study On How Well Macimorelin Works For Growth Hormone Deficiency Diagnosis

* Aeterna Zentaris Inc (NASDAQ: AEZS) has commenced its pivotal Phase 3 DETECT trial evaluating macimorelin as a diagnosis of childhood-onset growth hormone deficiency (CGHD).

* The investigational new drug application multicenter, open-label trial will investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test (GHST) in pediatric patients with suspected GHD.

* The macimorelin test will be compared to clonidine and an arginine test. Both are known standard stimulation tests.

* The study is expected to enroll approximately 100 participants.

* Patient enrollment on track to start this quarter, with trial completion expected in Q3 2022.

* Under new terms and conditions of the license agreement revised in November 2020, Aeterna will coordinate the activities related to the development of macimorelin in CGHD through a joint steering committee with Novo Nordisk A/S (NYSE: NVO).

* Price Action: AEZS shares are trading 2.91% higher at $0.91 during the premarket session on the last check Thursday.







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