- Aeterna Zentaris (TSX:AEZS) has successfully recruited patients for its first pediatric study of macimorelin as a Growth Hormone Deficiency diagnostic
- The study will take place in Hungary, Poland, Ukraine, Serbia, and Russia
- The study will seek to find a safe dosage which can also increase growth hormone in patients without GHD
- Results from the study should be available in the second quarter of 2020
- Aeterna Zentaris’ share price is down 2.5 per cent, and is trading at $1.56 per share.
Biopharmaceutical company Aeterna Zentaris (AEZS) has successfully completed patient recruitment for its first pediatric study of macimorelin.
The study will explore macimorelin’s potential as a diagnostic drug, for identifying Growth Hormone Deficiency (GHD) in children.
AEZS-130-P01, also known as Study P01, will take place in multiple countries, including Hungary, Poland, Ukraine, Serbia, and Russia.
Aeterna has enrolled a total of 24 pediatric subjects for testing. Patients range in age from 2 years of age to just under 18 years of age.
The European Medicines Agency has planned for two such studies, of which Study P01 is the first.
The first study will seek to find a macimorelin dosage that is safe for children, and can also increase growth hormone in patients who do not have GHD.
The dosage results of Study P01 are will hopefully come out in the second quarter of 2020. Study P02 will evaluate and further test the dosage results, along with the drugs’ efficacy as a diagnostic tool.
According to Aeterna’s Chief Medical Officer, Dr Nicola Ammer, “in all dosing cohorts of Study P01, macimorelin administration was completed safely at the end of December 2019”.
Aeterna CEO, Dr Klaus Paulini, called the recruitment “a significant milestone and an important step in the pediatric development of macimorelin in this important patient population.”
Aeterna Zentaris’ share price is down 2.5 per cent, and is trading at $1.56 per share.
