Aeterna Zentaris Phase3 Study For Macrilen In AGHD Meets EMA's Study-Design View

(RTTNews) - Aeterna Zentaris Inc. (AEZS, AEZ.TO) said Tuesday that it has received written scientific advice from the European Medicines Agency or "EMA" regarding the further development plan, including the study design, for the new confirmatory Phase 3 clinical study of Macrilen (macimorelin) for use in evaluating adult growth hormone deficiency or "AGHD", following a Scientific Advice Meeting that was held earlier this month.

As a result of the advice, the Company believes that the confirmatory Phase 3 study that was discussed with the U.S. Food & Drug Administration ("FDA") last March, meets the EMA's study-design expectations.

The multinational confirmatory efficacy Phase 3 clinical study with Macrilen for the evaluation of AGHD 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.

The company noted that it will submit a proposed final protocol to the FDA for their review prior to commencing the confirmatory efficacy Phase 3 study. A dedicated thorough Phase 3 QT study to evaluate the effect of Macrilen on myocardial repolarization is expected to be initiated in early 2016.

Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin, under the trade name Macrilen, has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this novel patented compound.