Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company") announced today that it has executed a definitive agreement with Ergomed PLC ("Ergomed"), pursuant to which Ergomed will 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."