Canadian biopharmaceutical firm Aeterna Zentaris has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its ghrelin agonist, macimorelin acetate (AEZS-130), a novel orally-active small molecule.
The submission is based on results from a Phase III trial that showed AEZS-130 has the potential to become the first orally-approved product that induces growth hormone release to assess adult growth hormone deficiency (AGHD), with accuracy compared to existing intravenous and intramuscular testing procedures.
Aeterna Zentaris president and CEO David Dodd said the submission NDA is another major milestone in the company's strategy to bring macimorelin acetate to market as the first approved oral product for AGHD evaluation.
"We are also looking at potential expansion into traumatic brain injury victims and pediatrics which would represent significant growth opportunities for the Company," Dodd said.
According to the company, Macimorelin acetate stimulates the secretion of growth hormone, which plays a major role in growth from childhood to adulthood as well as helps promote a hormonally-balanced health status.
Aeterna Zentaris owns the worldwide rights of AEZS-130 and has completed a Phase III trial to use it for assessing AGHD, which affects about 75,000 adults across the US, Canada and Europe.
Additionally, macimorelin acetate is in a Phase II trial as a treatment for cancer-induced cachexia.
AGHD is mostly caused from damage to the pituitary gland and is usually characterized by a reduction in bone mineral density, lean mass, exercise capacity and overall quality of life.
