Aeterna Zentaris Inc. has executed a definitive agreement with Ergomed to manage the new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD").
David A. Dodd, Chairman, President and Chief Executive Officer of the Company remarked regarding the selection of Ergomed, "We have great confidence in Ergomed's ability to conduct our confirmatory clinical study of Macrilen™ on schedule and within budget. Ergomed's performance as our clinical research organization supporting our pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer has been excellent. We are committed to Macrilen™ because of our confidence in its efficacy and safety and the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD."
Miroslav Reljanovic, M.D., CEO of Ergomed said, "We are delighted that Aeterna Zentaris has selected us to manage their confirmatory study of Macrilen™. We have a strong and deep working relationship with the Company's scientific staff and hold them in the highest regard."
About the Study
The confirmatory Phase 3 clinical study of Macrilen™ will be conducted as a two-way crossover study with the insulin tolerance test as the benchmark comparator. The study population will consist of patients with a medical history documenting risk factors for AGHD and will include a spectrum of patients from those with a low risk of having AGHD to those with a high risk of having the condition. Based on meetings with the US FDA as well as the European Medicines Agency (the "EMA") and subsequent written scientific advice, the Company believes that the study meets FDA's and EMA's study-design expectations allowing US and European approval, if successful.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin, under the trade name MacrilenTM, has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this novel patented compound.
About Adult Growth Hormone Deficiency (AGHD)
AGHD affects approximately 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life.