Aeterna Zentaris To Conduct Macrilen Phase 3 Study - Quick Facts

(RTTNews) - Aeterna Zentaris Inc. (AEZS, AEZ.TO) announced plans to conduct a new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen, a ghrelin agonist, as well as a dedicated thorough QT study to evaluate the effect of Macrilen on myocardial repolarization.

Macimorelin is a 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 adult growth hormone deficiency.

The company said the decision follows a meeting with the U.S. FDA regarding its New Drug Application for Macrilen. The company requested the meeting to gain clarity on the approval deficiencies described in the Complete Response Letter the company received on November 6, 2014.

The company's goal is to conduct a Phase 3 study that will satisfy the registration requirements of the European Medicines Agency (EMA) as well as the FDA. The company believes the completion of the confirmatory Phase 3 study and the QT study will take about 18 months.