Aeterna Zentaris has selected Ergomed to manage the confirmatory Phase 3 clinical study demonstrating the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (AGHD).
Regarding the decision to select Ergomed, Aeterna Zentaris president and CEO David A. Dodd said: “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 organisation supporting our pivotal Phase 3 ZoptEC 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.”
Ergomed CEO Miroslav Reljanovic added: "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 Aeterna Zentaris scientific staff and hold them in the highest regard. Ergomed is committed to developing orphan drugs, and we believe that Macrilen has the potential to provide a much needed tool for the evaluation of AGHD.”
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 Aeterna Zentaris believes that the study meets FDA’s and EMA’s study-design expectations allowing US and European approval, if successful.